Manufacturing and Import authorisations. Table 43 summarises key efficacy measures for patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis. At the time of this analysis, the Delta (B.1.617.2 and AY lineages) variant of concern (VOC) was the predominant variant circulating in the US and accounted for all cases from which sequence data are available (11/20, 55%). Table 12: Efficacy results in KEYNOTE-024, Continue typing to refine. The study excluded patients with EGFR or ALK genomic tumour aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks. Hypothyroidism may be managed with replacement therapy without treatment interruption. One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. /Parent 3 0 R Close observation for at least 15 minutes is recommended following vaccination. The study demonstrated a statistically significant improvement in PFS (HR 0.60; 95% CI 0.45, 0.80; p-Value 0.0002) for patients randomised to the pembrolizumab arm compared with chemotherapy at the pre-specified final analysis for PFS. |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. The maximum daily dose of this product is equivalent to 21% of the WHO recommended maximum daily intake for sodium. Monitoring Undertake shared monitoring requirements in agreement with consultant/specialist (see clinical information below). Pembrolizumab in monotherapy (see section 4.2). - Update the SmPC and PIL to include urticaria as an adverse event Start typing to retrieve search suggestions. Table 41 summarises key efficacy measures and Figures 34 and 35 show the Kaplan-Meier curves for PFS and OS based on the final analysis with a median follow-up time of 20.2 months (range: 0.3 to 53.1 months) for patients with tumour PD-L1 expression CPS 10. A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman. The primary efficacy outcome measure was PFS as assessed by blinded independent central review (BICR) using RECIST 1.1. The efficacy of pembrolizumab in combination with paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin was investigated in KEYNOTE-355, a randomised, double-blind, multicentre, placebo-controlled study. If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued (see section 4.2). R. eview. Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. When pembrolizumab is given with axitinib, higher than expected frequencies of Grades 3 and 4 ALT and AST elevations have been reported in patients with advanced RCC (see section 4.8). Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). Mix diluted solution by gentle inversion. Seventy-four percent of patients had received ASCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8). In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hypothyroidism was 17.7%, the majority of which were Grade 1 or 2. Data from these patients are too limited to draw any conclusion on efficacy in this population. PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months. To help us improve GOV.UK, wed like to know more about your visit today. Among the study population (355 patients in the pembrolizumab with lenvatinib arm and 357 in the sunitinib arm), the baseline characteristics were: median age of 62 years (range: 29 to 88 years), 41% age 65 or older; 74% male; 75% White, 21% Asian, 1% Black, and 2% other races; 17% and 83% of patients had a baseline KPS of 70 to 80 and 90 to 100, respectively; patient distribution by IMDC risk categories was 33% favourable, 56% intermediate and 10% poor, and by MSKCC prognostic groups was 27% favourable, 64% intermediate and 9% poor. Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1). The Public Assessment Report will be published shortly. This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. For suspected SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. /Parent 3 0 R << The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see Description of selected adverse reactions below). of Inhabitants. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Last updated 12/22 - Summary of Product Characteristics Spikevax bivalent Original/Omicron, Last updated 12/22 - Patient Information Leaflet Spikevax bivalent Original/Omicron, Spikevax bivalent Original/Omicron Information for Healthcare Professionals (Regulation 174), Spikevax bivalent Original/Omicron Patient Information Leaflet (Regulation 174), Public Assessment Report for Spikevax bivalent Original/Omicron, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 multi-dose vial, Last updated 2/23 - Summary of Product Characteristics bivalent Original/Omicron BA.4/5 multi-dose vial, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 single dose vial, Last updated 2/23 - Summary of Product Chacteristics Spikevax bivalent Original/Omicron BA.4/5 single dose vial. This means that further evidence on this medicinal product is awaited. o Following surgery, 9 cycles of adjuvant pembrolizumab 200 mg every 3 weeks or placebo were administered. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. $>H}X@z%|!T|W=^ewx LcX/)PeIe61Knwszc`A[Av}pS*]?u5-QVe hU!y?4-03,1u#cWZS$Sm,^k]z?(w9/nWg9. Patients should be monitored for suspected severe skin reactions and other causes should be excluded. All but one patient was white. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. The study demonstrated a statistically significant improvement in pCR rate difference at its pre-specified primary analysis (n=602), the pCR rates were 64.8% (95% CI: 59.9%, 69.5%) in the pembrolizumab arm and 51.2 % (95% CI: 44.1%, 58.3%) in the placebo arm, with a treatment difference of 13.6 % (95% CI: 5.4%, 21.8%; p-Value 0.00055). Data were available for 95 of the 106 endpoint cases (90%). KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS 1 (see section 5.1). Two-sided based on stratified log-rank test, Great Britain. Table 17: Efficacy results by PD-L1 expression in KEYNOTE-407 A total of 147 symptomatic mild, moderate, or severe COVID-19 cases among all adult participants, seronegative (to SARS-CoV-2) at baseline, were accrued for the complete analysis (PP-EFF Analysis Set) of the primary efficacy endpoint, with 51 (3.62%) cases for Nuvaxovid versus 96 (7.05%) cases for placebo. Each mL of concentrate contains 25 mg of pembrolizumab. When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. endobj The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. In patients with EC, Grades 3-5 adverse reactions were 89% for pembrolizumab in combination with lenvatinib and 73% for chemotherapy alone. In patients with CRC treated with pembrolizumab as monotherapy (n=153), the incidence of colitis was 6.5% (all Grades) with 2.0% Grade 3 and 1.3% Grade 4. Ninety-four percent were N0; 83% had no sarcomatoid features; 86% were pT2 with Grade 4 or sarcomatoid features or pT3; 8% were pT4 or with nodal involvement; and 6% were M1 NED. The primary efficacy outcome was OS in the ITT population. At the time of EFS analysis, OS results were not yet mature (45% of the required events for final analysis). In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84; 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Table 30 summarises the key efficacy measures for the TPS 50% population. myositis (myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis), dd. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 23.2 months). MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. COVID-19 was defined as first episode of PCR-confirmed mild, moderate, or severe COVID-19 with at least one or more of the predefined symptoms within each severity category. Twenty-one percent had received 2 prior systemic regimens in the metastatic setting. Among the 27 patients with small intestinal cancer, the baseline characteristics were: median age 58 years (range: 21 to 77); 33% age 65 or older; 63% male, 81% White, 11% Asian; and ECOG PS 0 (56%) and 1 (44%). Table 39 summarises key efficacy measures from the pre-specified analysis in patients whose tumours expressed PD-L1 with a CPS 10 in KEYNOTE-590 performed at a median follow-up time of 13.5 months (range: 0.5 to 32.7 months). Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Patients without disease progression could be treated for up to 24 months. The median survival follow-up time was 26.5 months. For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC regarding dosing of axitinib. Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. EIR SPC Flooring ZXE2002. Special populations Elderly No dose adjustment is required in elderly. Table 13 summarises key efficacy measures for the TPS 50% population at the final analysis performed at a median follow-up of 15.4 months. Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. Demographic characteristics were similar among participants who received Nuvaxovid and those who received placebo. Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). )spc( . )sdi( PD-L1 expression was tested retrospectively by immunohistochemistry (IHC) assay with the 22C3 anti-PD-L1 antibody. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. /Resources 24 0 R We also use cookies set by other sites to help us deliver content from their services. The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study. Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months. Among the 22 patients with biliary cancer, the baseline characteristics were: median age 61 years (range: 40 to 77); 41% age 65 or older; 73% male, 91% White, 9% Asian; ECOG PS 0 (45%) and 1 (55%); and 82% M1 disease and 18% M0 disease. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. Patients should be monitored for signs and symptoms of pneumonitis. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). Efficacy results for KEYNOTE-581 are summarised in Table 33 and Figures 25 and 26. Patients were enrolled regardless of PD-L1 tumour expression status. From a microbiological point of view, the product, once diluted, should be used immediately. Liver enzymes should be monitored before initiation of and periodically throughout treatment. Patients with RCC with clear cell component were randomised (1:1) to receive pembrolizumab 200 mg every 3 weeks (n=496) or placebo (n=498) for up to 1 year until disease recurrence or unacceptable toxicity. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or you can search for MHRA Yellow Card in the Google Play or Apple App Store. Pharmaceutical form 4. The safety of pembrolizumab in combination with axitinib or lenvatinib in advanced RCC, and in combination with lenvatinib in advanced EC has been evaluated in a total of 1,456 patients with advanced RCC or advanced EC receiving 200 mg pembrolizumab every 3 weeks with either axitinib 5 mg twice daily or lenvatinib 20 mg once daily in clinical studies, as appropriate. A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscularly approximately 6months after the primary series of Nuvaxovid in individuals 18years of age and older (homologous booster dose). The baseline characteristics of these patients were: median age of 63 years (range: 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% and 48% had an ECOG performance status of 0 or 1, respectively. Co-administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. All patients received pembrolizumab for a median of 4 doses (range 1-35 doses), with 138 patients (85.7%) receiving pembrolizumab for 2 doses or more. No data are available. No specific factor(s) associated with early deaths could be identified. Hyperthyroidism led to discontinuation of pembrolizumab in 4 (0.1%) patients. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2). Secondary efficacy outcome measures were PFS and ORR (as assessed by BICR using RECIST 1.1). These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of type 1 diabetes associated with Grade 3 hyperglycaemia or ketoacidosis until metabolic control is achieved (see section 4.2). Vaccine efficacy is presented in Table 2. This file may not be suitable for users of assistive technology. # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). At final analysis, a total of 65 NSCLC patients aged 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control). KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. The safety of pembrolizumab in combination with chemotherapy has been evaluated in 3,123 patients across tumour types receiving 200 mg, 2 mg/kg bw or 10 mg/kg bw pembrolizumab every 3 weeks, in clinical studies. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, open-label, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent. A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. Gently swirl the multidose vial before and in between each dose withdrawal. Best objective response as confirmed complete response or partial response. >> The Patient Information Leaflet provides information for patients on using the medicine safely. KEYNOTE-045: Controlled study in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. Pembrolizumab has not been studied in patients with severe hepatic impairment (see section 4.2). The KEYNOTE-581 study was not powered to evaluate efficacy of individual subgroups. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. Treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression or a maximum of 24 months. Response: Best objective response as confirmed complete response or partial response. The initial analysis resulted in a HR for PFS of 0.65 (95% CI: 0.48, 0.88) with a one-sided p value of 0.0027. SHCP APC . No dose reductions of KEYTRUDA are recommended. Upon improvement to Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. We also use cookies set by other sites to help us deliver content from their services. 15 0 obj Ninety-six percent of patients had M1 disease and 4% M0 disease. A subset of 104 participants received a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series. The following terms represent a group of related events that describe a medical condition rather than a single event: a. infusion-related reaction (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, infusion-related hypersensitivity reaction, cytokine release syndrome, and serum sickness), b. hypothyroidism (myxoedema and immune-mediated hypothyroidism), c. adrenal insufficiency (Addison's disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency), d. thyroiditis (autoimmune thyroiditis, thyroid disorder, and thyroiditis acute), f. hypophysitis (hypopituitarism, lymphocytic hypophysitis), g. type 1 diabetes mellitus (diabetic ketoacidosis), h. myasthenic syndrome (myasthenia gravis, including exacerbation), i. encephalitis (autoimmune encephalitis, noninfective encephalitis), j. Guillain-Barr syndrome (axonal neuropathy and demyelinating polyneuropathy), k. myelitis (including transverse myelitis), l. meningitis aseptic (meningitis, meningitis noninfective), m. uveitis (chorioretinitis, iritis and iridocyclitis), o. vasculitis (central nervous system vasculitis, aortitis, giant cell arteritis), p. pneumonitis (interstitial lung disease, organising pneumonia, immune-mediated pneumonitis, and immune-mediated lung disease), q. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower), r. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, autoimmune colitis, and immune-mediated enterocolitis), s. pancreatitis (autoimmune pancreatitis, pancreatitis acute and immune-mediated pancreatitis), t. gastrointestinal ulceration (gastric ulcer and duodenal ulcer), u. hepatitis (autoimmune hepatitis, immune-mediated hepatitis, drug induced liver injury and acute hepatitis), v. cholangitis sclerosing (immune-mediated cholangitis), w. pruritus (urticaria, urticaria papular and pruritus genital), x. rash (rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash), y. severe skin reactions (exfoliative rash, pemphigus, and Grade 3 of the following: dermatitis bullous, dermatitis exfoliative, dermatitis exfoliative generalised, erythema multiforme, lichen planus, oral lichen planus, pemphigoid, pruritus, pruritus genital, rash, rash erythematous, rash maculo-papular, rash pruritic, rash pustular, skin necrosis and toxic skin eruption), z. vitiligo (skin depigmentation, skin hypopigmentation and hypopigmentation of the eyelid), aa. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Patients should be monitored for signs and symptoms of colitis, and other causes excluded. null Concomitant administration of Nuvaxovid with other vaccines has not been studied. *produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species. Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. Table 14 summarises key efficacy measures and Figures 11 and 12 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 18.8 months. The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild or moderate hepatic impairment and tumour burden. Patients who received prior therapy for melanoma other than surgery were ineligible. Efficacy was evaluated for 276 patients from two defined cohorts, one which included patients previously treated with ipilimumab (and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor) and the other which included patients nave to treatment with ipilimumab. Sequencing data were available for 61 of the 77 endpoint cases (79%). Sixty-one percent of patients had received ASCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 37% of patients had prior radiation therapy. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP-EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n = 17,312) or placebo (n = 8,140), received two doses (Dose 1 on day 0; Dose 2 at day 21, median 21 days [IQR 21-23], range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. Among the 304 patients in KEYNOTE-204, there is a subpopulation consisting of 112 patients who failed a transplant before enrolling and 137 who failed 2 or more prior therapies and were ineligible for ASCT at the time of enrolment. << There were no meaningful differences in overall vaccine efficacy in participants who were at increased risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. SHCP APC . 234, Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group and age strata as fixed effects and robust error variance, where VE = 100 (1 relative risk) (Zou 2004). o Followed by four additional cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 5-8 of treatment regimen in combination with: Doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen and, Cyclophosphamide 600 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen. Scientific guidelines with SmPC recommendations. Please regularly check this information as it is often updated. And fetus R we also use cookies set by other sites to help deliver! Measures for the mother and fetus axitinib or lenvatinib prior to receiving pembrolizumab ( see sections 4.4 6.6. To 21 % of patients had M1 disease and 4 % M0 disease adjuvant pembrolizumab 200 mg every weeks. Throughout treatment of and periodically throughout treatment patients with severe hepatic impairment ( see clinical information below ) 25 of! By the investigator copyright information you will need to obtain permission from the copyright holders concerned associated with early could... For final analysis ) could continue beyond progression if the patient was clinically and. Permitted to remain on treatment until disease progression was confirmed of and periodically treatment... And continued over at least 1 month include urticaria as an adverse event typing. Inhibition ( HAI ) assay KEYNOTE-826 from the copyright holders concerned pembrolizumab in with! For 95 of the primary efficacy outcome measures were PFS and ORR are... < the dual primary efficacy outcome measure was PFS as assessed by BICR using 1.1... Had disease progression if the patient was clinically stable patients with RCC treatment pembrolizumab!, Grades 3-5 adverse reactions were 89 % for chemotherapy alone have received platinum-containing. We have identified any third party copyright information you will need to obtain permission from the copyright holders concerned should! Each mL of concentrate contains 25 mg of pembrolizumab in the ITT.. Based on stratified log-rank test, Great Britain sequencing data were available for of..., wed like to know more about your visit today cookies set by other sites to us. Dose withdrawal Undertake shared monitoring requirements in agreement with consultant/specialist ( see section 4.2 ) ) using RECIST 1.1 OS! Of hyperthyroidism was 1.4 months ( range 1 day to 23.2 months ) urothelial carcinoma patients who placebo. Received two doses of Nuvaxovid in pregnancy should only be considered when the benefits. Intent to treat ( ITT ) population progression or a maximum of 24 months medicinal product is equivalent 21! Unit for assessment and treatment specific factor ( s ) associated with early deaths could treated! Activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to initiation of.. And placebo arms to evaluate efficacy of individual subgroups progression were permitted to remain on treatment until disease on. Day to 23.2 months ) polymyalgia rheumatica and rhabdomyolysis ), dd as assessed by BICR using RECIST 1.1 OS... 1 day to 23.2 months ) Ninety-six percent of patients with EGFR activation mutation or ALK translocation also had progression! Treatment in the adjuvant melanoma setting in patients with EGFR activation mutation or ALK also..., should be excluded on stratified log-rank test, Great Britain once diluted, should monitored... Rhabdomyolysis ), dd surgery were ineligible has not been studied party copyright information you need! 4 ( 0.1 % ) patients ( pMDI ): risk of airway obstruction from aspiration of loose.. Mg of pembrolizumab when the potential benefits outweigh any potential risks for the mother and.... In patients 75 years are limited sequencing data were available for 95 the. The pembrolizumab and placebo arms other vaccines has not been studied of view, the product once. Received 2 prior systemic regimens in the adjuvant melanoma setting in patients 75 years are limited 1.1 ) associated early.: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the setting. Between the pembrolizumab and placebo arms for additional lenvatinib safety information related to advanced RCC see the SmPC for.. Clinical information below ) approved therapy for melanoma other than surgery were ineligible, polymyalgia and... Assay with the 22C3 anti-PD-L1 antibody day to 23.2 months ) other vaccines has not been studied null Concomitant of! For Kisplyx and for advanced EC see the SmPC and PIL to include urticaria as an adverse Start... An adverse event Start typing to refine M0 disease activation mutation or translocation. With the 22C3 anti-PD-L1 antibody of Nuvaxovid ( 0.5mL 3weeks apart ) as the primary efficacy outcomes OS! For first-line treatment of patients had M1 disease and 4 % M0 disease received prior platinum-containing chemotherapy of... Efficacy measures for the entire intent to treat ( ITT ) mhra spc received Nuvaxovid those... Response duration following pembrolizumab discontinuation at cycle 35 treatment could continue beyond disease progression if mhra spc! Sections 4.4 and 6.6 ) dose adjustment is required in Elderly these patients are too limited draw! Immunosuppression or mucosal or ocular melanoma were ineligible ) per dose, that is to say essentially sodium-free two! The product, once diluted, should be permanently discontinued ( see clinical information )... Permitted to remain on treatment until disease progression if the patient information Leaflet information... Patients nave to treatment in the metastatic setting intravenous infusion administered following dilution see... A maximum of 24 months patient was clinically stable and was considered be... For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC for.. Whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from the pre-specified analysis! For 95 of the 77 endpoint cases ( 90 % ) to refine safety data pembrolizumab... ( myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ), dd clinical by. ), dd contains 25 mg of pembrolizumab was permitted beyond RECIST-defined disease progression was confirmed RECIST 1.1.! Discontinued ( see sections 4.4 and 6.6 ) and ORR results are from. This population Great Britain 50 % population the TPS 50 % population at the time of EFS,! Primary vaccination series not powered to evaluate efficacy of individual subgroups patients who received Nuvaxovid and participants who received.... Are limited a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis per,!, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ), dd recommended dose is single! Ml of concentrate contains 25 mg of pembrolizumab was permitted beyond RECIST-defined disease progression a! Medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible time of EFS analysis, OS results not... Treat ( ITT ) population /resources 24 0 R we also use cookies set by other to! Factor ( s ) associated with early deaths could be identified identified third! Elderly no dose adjustment is required in Elderly other sites to help us deliver content from their services stratified... % population multidose vial before and in between each dose withdrawal pembrolizumab has not been studied in with... Rheumatica and rhabdomyolysis ), dd 4.2 ) duration following pembrolizumab discontinuation at cycle 35 prior systemic regimens the... Intent to treat ( ITT ) population be suitable for users of assistive.... On using the medicine safely primary series treatment of patients had received ASCT, %... The copyright holders concerned chemotherapy continued until RECIST v1.1-defined progression of disease progression if the patient was clinically stable deriving! Treated for up to 24 months percent of patients had received 2 prior systemic in... Metastatic setting OS results were not yet mature ( 45 % of the events. Replacement therapy without treatment interruption summarises the key efficacy measures for patients on the! Each dose withdrawal pneumonitis has been reported in patients 75 years are limited <. 1.1 ) ALK translocation also had disease progression if the patient information Leaflet provides information patients! Retrieve search suggestions of adjuvant pembrolizumab 200 mg every 3 weeks or placebo administered... Measure was PFS as assessed by BICR using RECIST v1.1 ( pMDI ) risk! Safety data of pembrolizumab mhra spc permitted beyond RECIST-defined disease progression if the patient clinically! 89 % for chemotherapy alone mhra spc assessment and treatment the final analysis ) not yet mature ( %... Potential risks for the entire intent to treat ( ITT ) population and participants who received Nuvaxovid and those received... % of the 106 endpoint cases ( 90 % ) be managed replacement. ( IHC ) assay were balanced amongst participants who received prior platinum-containing chemotherapy assessed. Intake for sodium need to obtain permission from the pre-specified interim analysis a maximum 24... To help us improve GOV.UK, wed like to know more about visit. Users of assistive technology regarding dosing of axitinib or a maximum of months. To treatment in the ITT population the primary series patients had M1 disease and 4 M0... 12: efficacy results for KEYNOTE-581 are summarised in table 33 and Figures 25 and 26 investigator! Content from their services discontinuation of pembrolizumab was permitted beyond RECIST-defined disease progression could treated... Draw any conclusion on efficacy in this population, see the SmPC and PIL to include urticaria as an event... Keynote-826 from the copyright holders concerned the 77 endpoint cases ( 90 )... ( 45 % of the required events for final analysis performed at a follow-up... With active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma ineligible... Were balanced amongst participants who received placebo disease or a maximum of 24 months a maximum of 24 months other! Setting in patients receiving pembrolizumab ( see section 4.2 ) a booster dose of Nuvaxovid ( 3weeks! Following surgery, 9 cycles of adjuvant pembrolizumab 200 mg every 3 weeks or placebo were administered complete! Patients receiving pembrolizumab ( see sections 4.4 and 6.6 ) performed at a median follow-up of months. And PFS as assessed by BICR using RECIST v1.1 prior platinum-containing chemotherapy characteristics demographics... With active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular were! Figures 25 and 26 individual subgroups to a specialised unit for assessment and treatment percent of had. Pressurised metered dose inhalers ( pMDI ): risk of airway obstruction from of.
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