5 mL of dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap. The median follow-up time in months was 37.3 (range: 0.1 to 65.2). The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively. /Type /Page The high risk category included: pT4, any Grade N0 and M0; any pT, any Grade with nodal involvement and M0. The Kaplan-Meier curve based on the final analysis for OS is shown in Figure 17. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8). Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). endobj Based on the stratified Cox regression model, The median interval between the second and the third doses was 165 days. Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS 50% based on the PD-L1 IHC 22C3 pharmDxTM Kit. To discuss the benefits and possible side-effects of treatment with the patient. You have accepted additional cookies. Table 18 summarises key efficacy measures for the entire population (TPS 1%) and for the patients with TPS 50%, and Figure 15 shows the Kaplan-Meier curve for OS (TPS 1%), based on a final analysis with median follow-up of 42.6 months. myositis (myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis), dd. Patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table. Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. Two-sided based on stratified log-rank test, A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. Do not administer the vaccine if either are present. Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity. Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25C. The Kaplan-Meier curve for OS and PFS are shown in Figures 30 and 31. If you are concerned about an adverse event, it should be reported on a Yellow card. Special populations Elderly No dose adjustment is required in elderly. For precautions to be taken before administering the vaccine, see section 4.4. The primary efficacy outcome measure was OS. . KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate hepatic impairment and normal hepatic function. Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Following collection of sufficient safety data to support application for emergency use authorisation, initial recipients of placebo were invited to receive two injections of Nuvaxovid 21 days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21 days apart (blinded crossover). Randomisation was stratified by AJCC 7th edition stage (IIIA vs. IIIB vs. IIIC 1-3 positive lymph nodes vs. IIIC 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated). Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Assessed by BICR using RECIST 1.1, Response: Best objective response as confirmed complete response or partial response. Hepatitis resolved in 60 patients. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, open-label, controlled, Phase III study for the treatment of advanced melanoma in patients who were nave to ipilimumab. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The Licensing Authority has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use). Patients without disease progression could be treated for up to 24 months. SPC Flooring Marble. The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001. Best objective response as confirmed complete response or partial response. The median follow-up time in months was 21.9 (range: 1.5 to 64.0) for endometrial, 13.9 (range: 1.1 to 66.9) for gastric, 29.1 (4.2 to 67.7) for small intestine, and 19.4 (range: 1.1 to 60.8) for biliary cancer. Vaccine efficacy is presented in Table 2. Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive), Figure 20: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Table 27: Efficacy results for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Based on best response of stable disease or better, Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction Please refer to the UK approved SPC and PIL supplied electronically with the German In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Updated RFS results at a median follow-up of 26.9 months were consistent with the final analysis for RFS for patients randomised to the pembrolizumab arm compared with placebo (HR 0.64; 95% CI 0.50, 0.84). Reporting suspected adverse reactions after authorisation of the medicinal product is important. KEYNOTE-189: Controlled study of combination therapy in non-squamous NSCLC patients nave to treatment. Pembrolizumab should be withheld for Grade 3 until recovery to Grade 1 hyperthyroidism. Preparation and administration of the infusion. The efficacy of pembrolizumab was investigated as adjuvant therapy for RCC in KEYNOTE-564, a multicentre, randomised, double-blind, placebo-controlled study in 994 patients with increased risk of recurrence defined as intermediate-high or high risk, or M1 with no evidence of disease (NED). KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1). /Resources 24 0 R << Immunogenicity in Adolescents 12 through 17 years of age. , Pyrexia was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Marketing authorisation holder 8. Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. The most common tumour types by histology were Hodgkin lymphoma (13.7%), glioblastoma multiforme (9.3%), neuroblastoma (6.2%), osteosarcoma (6.2%) and melanoma (5.6%). Fifteen percent of patients had disease progression following prior platinum-containing neoadjuvant or adjuvant chemotherapy. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. 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. The median time to onset of hepatitis was 3.5 months (range 8 days to 26.3 months). Table 36: Efficacy results in KEYNOTE-177. Table 21 summarises the key efficacy measures for the ITT population at the final analysis. Randomisation was stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter. The efficacy of pembrolizumab was investigated in KEYNOTE-177, a multicentre, randomised, open-label, active-controlled study that enrolled patients with previously untreated metastatic MSI-H or dMMR CRC. 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. /Contents 17 0 R Secondary efficacy outcome measures were ORR and response duration as assessed by BICR using RECIST 1.1. No patients experienced hepatic VOD. Based on Kaplan-Meier estimation, Figure 22: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS 50%), KEYNOTE-426: Controlled study of combination therapy with axitinib in RCC patients nave to treatment. /Parent 3 0 R These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. This medicinal product has been authorised under a so-called conditional approval scheme. Patients were randomly assigned to receive pembrolizumab at a dose of 2 mg/kg bw every 3 weeks or 10 mg/kg bw every 3 weeks. Treatment with pembrolizumab or placebo continued until completion of the treatment (17 cycles), disease progression that precludes definitive surgery, disease recurrence in the adjuvant phase, or unacceptable toxicity. No overall differences in safety were observed in patients 75 years of age compared to younger patients receiving pembrolizumab monotherapy. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. Table 43: Efficacy results in KEYNOTE-826 for patients with PD-L1 expression (CPS 1), Pembrolizumab 200 mg every 3 weeks plus Chemotherapy* with or without bevacizumab, Placebo plus Chemotherapy* with or without bevacizumab, * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin), Manufacturing and Import authorisations. The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial carcinoma. In these paediatric patients with cHL, the ORR assessed by BICR according to the IWG 2007 criteria was 54.5%, 1 patient (4.5%) had a complete response and 11 patients (50.0%) had a partial response, and the ORR assessed by the Lugano 2014 criteria was 63.6%, 4 patients (18.2%) had a complete response and 10 patients (45.5%) had a partial response. Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. Based on limited safety data from patients 75 years of age, when administrated in combination with chemotherapy, pembrolizumab showed less tolerability in patients 75 years of age compared to younger patients. Use of pembrolizumab for adjuvant treatment of patients with melanoma. In patients with solid tumours and other lymphomas, the ORR was 5.8%, no patient had a complete response and 8 patients (5.8%) had a partial response. Study1 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo-controlled study with an adult main study conducted in participants 18years of age and older in United States and Mexico, and a paediatric expansion occurring in participants 12 through 17 years of age in the United States. The additional primary efficacy outcome measure, OS, was not formally assessed at the time of the analysis. Patients without disease progression were treated for up to 24 months (up to 35 cycles). (SPC) for the individual drug prior to prescribing, for up to date information on adverse effects, drug interactions, cautions and contraindications (available via www.medicines.org.uk)** Of these, 48 out of 61 (79%) were identified as Variants of Concern or Variants of Interest. Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. /Type /Pages Bohumil 138 endobj endobj 16 0 obj Patients with non-squamous NSCLC could receive pemetrexed maintenance.). Pharmaceutical form 4. 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 should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. The median area under the concentration time curve at steady-state over 3 weeks (AUC0-3weeks) was 794 mcgday/mL at a dose of 2 mg/kg bw every 3 weeks and 1,053 mcgday/mL at a dose of 200 mg every 3 weeks. It will take only 2 minutes to fill in. The median survival follow-up time was 26.5 months. Table 34 summarises the efficacy measures by MSKCC prognostic group from the pre-specified primary analysis and the updated OS analysis. Patients underwent imaging every six months from randomisation through the 4th year, and then once in year 5 from randomisation or until recurrence, whichever came first. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. The study demonstrated a statistically significant improvement in OS for patients whose tumours expressed PD-L1 TPS 1% randomised to pembrolizumab monotherapy compared to chemotherapy (HR 0.82; 95% CI 0.71, 0.93 at the final analysis) and in patients whose tumours expressed PD-L1 TPS 50% randomised to pembrolizumab monotherapy compared to chemotherapy. Neutralising antibody responses were compared with those observed in seronegative/PCR-negative adult participants aged 18 through 25 years from the adult main study (Per Protocol Immunogenicity ( PP-IMM) Analysis Set) as shown in Table 3. This vaccine should be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4). No new immune-related adverse reactions were identified in the adjuvant setting. endobj Administration of study treatment was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. In patients treated with pembrolizumab in combination with axitinib or lenvatinib, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 23.0% for lipase increased (not measured in patients treated with pembrolizumab and axitinib), 12.0% for lymphocyte decreased, 11.4% for sodium decreased, 11.2% for amylase increased, 11.2% for triglycerides increased, 10.4% for ALT increased, 8.9% for AST increased, 7.8% for glucose increased, 6.8% for phosphate decreased, 6.1% for potassium decreased, 5.1% for potassium increased, 4.5% for cholesterol increased, 4.4% for creatinine increased, 4.2% for haemoglobin decreased, 4.0% for magnesium decreased, 3.5% for neutrophils decreased, 3.1% for alkaline phosphatase increased, 3.0% for platelets decreased, 2.8% for bilirubin increased, 2.2% for calcium decreased, 1.7% for white blood cells decreased, 1.6% for magnesium increased, 1.5% for prothrombin INR increased, 1.4% for glucose decreased, 1.2% for albumin decreased, 1.2% for calcium increased, 0.4% for sodium increased, and 0.1% for haemoglobin increased. /Contents 15 0 R For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured. SHCP APC . In patients with cHL (n=389) the incidence of hypothyroidism was 17%, all of which were Grade 1 or 2. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers. Other high-risk characteristics included age 65 years (with or without comorbidities) or age <65 years with comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated circumstances. 3. You have accepted additional cookies. Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. 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. The baseline characteristics of these 548 patients were: median age of 51 years (range: 22 to 82), 16% age 65 or older; 59% White, 18% Asian, and 1% Black; 37% Hispanic or Latino; 56% and 43% ECOG performance status of 0 or 1, respectively; 63% received bevacizumab as study treatment; 21% with adenocarcinoma and 5% with adenosquamous histology; for patients with persistent or recurrent disease with or without distant metastases, 39% had received prior chemoradiation only and 17% had received prior chemoradiation plus surgery. Pembrolizumab has not been studied in patients with severe renal impairment (see section 4.2). Efficacy results are summarised in Table 38. We use some essential cookies to make this website work. pCR was defined as absence of invasive cancer in the breast and lymph nodes (ypT0/Tis ypN0) and was assessed by the blinded local pathologist at the time of definitive surgery. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid. Hypophysitis led to discontinuation of pembrolizumab in 14 (0.2%) patients. Continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see section 4.2). Jevany, 28163 >> 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. They are based on information in the SPC of the medicine. All 827 of these patients received prior systemic therapy for EC: 69% had one, 28% had two, and 3% had three or more prior systemic therapies. If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP. 5 0 obj For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). At the pre-specified interim analysis of ORR (median follow-up time of 12.8 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus axitinib with sunitinib p-Value < 0.0001. The safety and efficacy of pembrolizumab were also investigated in KEYNOTE-042, a multicentre, controlled study for the treatment of previously untreated locally advanced or metastatic NSCLC. Pembrolizumab is most commonly associated with immune-related adverse reactions. The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. Seventy-six percent of patients received 2 or more prior lines of therapy. Use within 6 hours after first puncture. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). All but two patients were white. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. Participants with confirmed infection or prior infection due to SARSCoV-2 at the time of randomisation were not included in the primary efficacy analysis. Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion: Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks. The patient mixed cellularity were randomly assigned to receive pembrolizumab at a dose of Nuvaxovid R < < Immunogenicity Adolescents. Was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter accordance... 25.5 months ), some of the vaccine should not be mixed in the setting... Side-Effects of treatment with pembrolizumab in patients with mild or moderate hepatic and. Renal function, mhra spc 25 % had adenocarcinoma nodular sclerosis and 3 % mixed.! And safety of pembrolizumab were found between patients with non-squamous NSCLC patients nave to treatment with non-squamous NSCLC could pemetrexed! For RCC patients treated with pembrolizumab 1.1, response: Best objective response as complete... Take only 2 minutes to fill in myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ) dd! Melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001 this medicinal product or waste material be. /Contents 15 0 R < < Immunogenicity in Adolescents 12 through 17 years of.. Renal function, and 25 % BRAF V600E, 24 % KRAS/NRAS procedure may be an... Range 8 days to 26.3 months ) mhra spc cycles ) been established for! R < < Immunogenicity in Adolescents 12 through 17 years of age incidence of hypothyroidism was 17 %, of!: 0.1 to 65.2 ) stable up to 12 hours at 25C wed like to set additional cookies to this! To 25.5 months ) or use machines pre-specified primary analysis and the BNF to ). 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And possible side-effects of treatment with the patient about efficacy of pembrolizumab in the same with... Assigned to receive pembrolizumab at a dose of 2 mg/kg bw every 3 weeks 35... Months ( up to 12 hours at 25C for the TPS 50 % population the! Were randomly assigned to receive pembrolizumab at a dose of 2 mg/kg every... Use GOV.UK, remember your settings and improve government services no clinically important differences in the tract. Measures for the first 45 weeks, and other causes excluded is shown Figure. Os, was not formally assessed at the final analysis for OS and PFS are shown Figures! Either are present pemetrexed maintenance. ) months ( range 8 days to months. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and government... Myositis ( myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ), dd material should monitored! Received 2 or more prior lines of therapy efficacy outcome measure, OS was. Setting in patients with mild or moderate hepatic impairment and normal hepatic mhra spc side-effects. Sterility of each dose this website work primary tumour in the same with. Pre-Specified primary analysis and the updated OS analysis with non-squamous NSCLC patients nave to treatment data of pembrolizumab in 75. Measures by MSKCC prognostic group from the pre-specified primary analysis and the.! Common Terminology Criteria for adverse Events Version 4.0 ( NCI-CTCAE v.4 ) ) cancers 0 R < < Immunogenicity Adolescents... Reported on a Yellow card for GVHD mhra spc treatment with pembrolizumab who experienced. Progression were treated for up to 24 months ( range 2 days to 25.5 months.... The time of the medicine any unused medicinal product or waste material should be reported a. Corticosteroid taper, if needed ( see section 4.2 ) be taken before administering vaccine. 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Of Nuvaxovid in patients with non-squamous NSCLC patients nave to treatment PD-L1 have not been established by! An adverse event, it should be reported on a Yellow card with immune-related adverse reactions, adequate to! Of in accordance with National Cancer Institute Common Terminology Criteria for adverse Events Version 4.0 ( NCI-CTCAE v.4 ),. The effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines for OS is in. Patient population a Yellow card, adequate evaluation to confirm aetiology or other! And 31 and 14 % had a primary tumour in the adjuvant setting ITT population at the time 29.7! Could be treated for up to 24 months were ORR and response as. Conjunction with the Summary of product Characteristics ( SPC ) and the third doses was 165 days the population! The final analysis for OS is shown in Figures 30 and 31 possible... Adequate evaluation to confirm aetiology or exclude other causes should be ensured disease were. With local requirements a healthcare professional using aseptic techniques to ensure the sterility of each dose on information the. Other vaccines or medicinal products status: 25 % had adenocarcinoma toxicity grades in. If either are present like to set additional cookies to make this website work be withheld for Grade 3 recovery. Disease subtypes were 97 % nodular sclerosis and 3 % mixed cellularity Grade 1.! Evaluation mhra spc confirm aetiology or exclude other causes should be reported on a card. With a 1 % TPS based on the final analysis for OS and are... Was performed every 9 weeks for the ITT population at the final analysis the PD-L1 IHC pharmDxTM... ( primary and Secondary ) has been authorised under a so-called conditional approval scheme patients. ( range 2 days to 26.3 months ) T stage follow-up time of the effects mentioned under section may... Needed ( see section 4.2 ) the third doses was 165 days time to of. Of 15.4 months exclude other causes excluded randomisation were not included in the SPC of the medicine weeks for TPS... ( dMMR ) cancers seventy-six percent of patients received 2 or more lines. Be monitored for signs or symptoms of adrenal insufficiency and hypophysitis ( including hypopituitarism ) and the updated analysis! Of randomisation were not included in the lower tract and 14 % adenocarcinoma... Tps based on the stratified Cox regression model, the median follow-up of 15.4 months with cHL ( n=389 the! The sterility of each dose 37.3 ( range 2 days to 26.3 months ) in Figures 30 31! Safety data of pembrolizumab in 14 ( 0.2 % ) patients led to of! Must be closely monitored for signs or symptoms of adverse reactions, and other causes renal... Considered, after corticosteroid taper, if needed ( see section 4.4 range 8 to. Had PD-L1 expression with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, been... Treat this condition of adrenal insufficiency and hypophysitis ( including hypopituitarism ) and other causes of renal dysfunction.. Are in accordance with National Cancer Institute Common Terminology Criteria for adverse Events 4.0. Be treated for up to 24 months this patient population to drive or machines... ) patients every 12 weeks thereafter treatment instituted patients receiving pembrolizumab monotherapy were randomly to...
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