Among the 976 patients, the baseline characteristics were: median age of 61 years (range 16-87; 39% age 65 or older; 2 adolescent patients [one per treatment arm]); 60% male; and ECOG PS of 0 (93%) and 1 (7%). The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; current diagnosis or treatment for cancer; autoimmune disease/condition; received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90 days; bleeding disorder or continuous use of anticoagulants; history of allergic reactions and/or anaphylaxis; were pregnant; or had a history of laboratory-confirmed diagnosed COVID-19. Based on Kaplan-Meier estimation, Figure 13: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407, Figure 14: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407. Response: Best objective response as confirmed complete response or partial response. Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. Seventy-six (47.2%) patients had 1 or more Grades 3 to 5 adverse reactions of which 5 (3.1%) patients had 1 or more adverse reactions that resulted in death. OS results met the pre-specified efficacy boundary of 0.0113 for statistical significance. Any questions on the content of this database should be addressed to [email protected]. Manufacturing and Import authorisations. Dose delay or discontinuation (see also section 4.4). Dont worry we wont send you spam or share your email address with anyone. Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. 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. << Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. Secondary efficacy outcome measures were duration of response, PFS, and OS. 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. The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). Dont worry we wont send you spam or share your email address with anyone. The baseline characteristics of these 249 patients were: median age 34 years (11% age 65 or older); 56% male; 80% White and 7% Asian and 58% and 41% with an ECOG performance status 0 and 1, respectively. *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. Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study. /Filter /FlateDecode 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. Identification of the Alpha variant was based on S gene target failure by PCR. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. All patients had a tumour histology of adenocarcinoma. Table 34 summarises the efficacy measures by MSKCC prognostic group from the pre-specified primary analysis and the updated OS analysis. Nephritis has been reported in patients receiving pembrolizumab (see section 4.8). Table 8 summarises efficacy results by PD-L1 expression. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. lichenoid keratosis (lichen planus and lichen sclerosus), bb. If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. For the neoadjuvant and adjuvant treatment of TNBC, patients should be treated with neoadjuvant KEYTRUDA in combination with chemotherapy for 8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as monotherapy for 9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks or until disease recurrence or unacceptable toxicity. Renfe Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours. either cisplatin or carboplatin with gemcitabine) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. Events of anaphylaxis have been reported with Nuvaxovid vaccines. An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. Assessment of tumour status was performed every 9 weeks through the first year, then every 12 weeks thereafter. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. Sixty-four percent had Stage IIB and 35% had Stage IIC. Two patients experienced hepatic VOD, one of which was fatal. Use within 6 hours after first puncture. We use some essential cookies to make this website work. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8). Forty-seven percent of patients received 2 or more prior lines of therapy. Patients were randomised 1:1:1 to one of the following treatment arms: Pembrolizumab 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU), Cetuximab 400 mg/m2 load then 250 mg/m2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU). Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045, Number (%#) of patients with duration 6 months, Number (%#) of patients with duration 12 months, When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. /MediaBox [0 0 595 842] Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease. >> One-sided p-Value based on log-rank test stratified by chemotherapy on study (taxane vs. gemcitabine and carboplatin) and prior treatment with same class of chemotherapy in the neoadjuvant setting (yes vs. no). Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. /ExtGState 32 0 R The median duration of treatment for pembrolizumab plus lenvatinib was 17.0 months. The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15). >> The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by nodal status, tumour size, and choice of carboplatin, # One-sided p-Value based on log-rank test stratified by nodal status, tumour size, and choice of carboplatin. /Contents 25 0 R 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. Otherwise treatment should be discontinued. A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in 1% of tumour and tumour-associated immune cells relative to all viable tumour cells MEL score) vs. PD-L1 negative. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates for male and female participants and racial groups, and across participants with medical comorbidities associated with high risk of severe COVID-19. Cardiology SPC abbreviation meaning defined here. endobj % Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel. 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. Continue typing to refine. Disease characteristics were squamous (21%) and non-squamous (70%); stage IIIA (2%); stage IIIB (7%); stage IV (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%). If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2C to 8C. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. Forty-one percent of patients received 2 or more prior lines of therapy. Represents (n1, n2) populations defined as: n1 = number of participants in adult main study (18 through 25 years) with non-missing neutralizing antibodies result Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2). Table 36 summarises the key efficacy measures and Figures 28 and 29 show the Kaplan Meier curves for updated PFS and OS based on the final analysis with a median follow-up time of 38.1 months (range: 0.2 to 58.7 months). The baseline characteristics of these 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours. It must be administered by infusion over 30 minutes. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. This means that further evidence on this medicinal product is awaited. The companies those comply their GMP regulations can export their pharmaceutical products to UK. Hi, As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults. Patients with autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. See section 4.8 for how to report adverse reactions. For Grades 3 or 4 infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2). Monitor for the development or worsening BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). The safety profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally, twice daily. The PFS HR (95% CI) for the favourable, intermediate and poor risk groups were 0.81 (0.53, 1.24), 0.69 (0.53, 0.90) and 0.58 (0.35, 0.94), respectively. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. The management guidelines for these adverse reactions are described in section 4.4. For efficacy data in patients 75 years of age please refer to the relevant section of each indication. /CropBox [0 0 595 842] Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible. Since the original supply disruption alert (SDA/2019/005) was issued on 15 October 2019, MHRA investigations have progressed. Pack sizes of 10, 20, 30, 40, 60 or 90 capsules. Patients were randomised (2:1) to receive one of the following regimens: Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=410), Placebo with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=206). Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor. The study demonstrated a statistically significant improvement in OS and PFS for all pre-specified study populations. Enrolment was completed in November 2020. Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anti-cancer agents. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Healthcare professionals or members of the public can use this service to find: The service provides the following types of documents: Summaries of Product Characteristics (SPCs) is a description of a medicinal products properties and the conditions attached to its use. Table 32: Efficacy results in KEYNOTE-426 by IMDC risk category, * n (%) for favourable, intermediate and poor risk categories for pembrolizumab/axitinib vs. sunitinib were: 138 (32%) vs. 131 (31%); 238 (55%) vs. 246 (57%); 56 (13%) vs. 52 (12%), respectively, KEYNOTE-581: Controlled study of combination therapy with lenvatinib in RCC patients nave to treatment. Use of pembrolizumab in combination with chemotherapy. Response: Best objective response as confirmed complete response or partial response, Figure 38: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1), * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin) with or without bevacizumab, Figure 39: Kaplan-Meier curve for progression free survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1). Nodular-sclerosis was the more represented cHL histological subtype (~ 81%) and bulky disease, B symptoms and bone marrow involvement were present in approximately 21%, 28% and 4% of patients, respectively. Assessed by investigator using RECIST 1.1, # One-sided p-Value for testing. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. KEYNOTE-361 is a Phase III, randomised, controlled, open-label clinical study of pembrolizumab with or without platinum-based combination chemotherapy (i.e. /CropBox [0 0 595 842] The safety and efficacy of pembrolizumab were investigated in KEYNOTE-010, a multicentre, open-label, controlled study for the treatment of advanced NSCLC in patients previously treated with platinum-containing chemotherapy. Placebo on Day 1 of each three-week cycle in combination with cisplatin 80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles and 5-FU 800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. endobj The safety and efficacy of pembrolizumab were investigated in KEYNOTE-002, a multicentre, double-blind, controlled study for the treatment of advanced melanoma in patients previously treated with ipilimumab and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor. EVUSHELD is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see sections 4.2, 5.1 and 5.2).. /Resources 18 0 R The results of a post-hoc exploratory subgroup analysis indicated a trend towards reduced survival benefit of pembrolizumab compared to chemotherapy, during both the first 4 months and throughout the entire duration of treatment, in patients who were never-smokers. Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance. Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. For 143 patients treated with chemotherapy, 56% received mFOLFOX6 with or without bevacizumab or cetuximab and 44% received FOLFIRI with or without bevacizumab or cetuximab. From a microbiological point of view, the product, once diluted, should be used immediately. Immune-related adverse reactions affecting more than one body system can occur simultaneously. Qualitative and quantitative composition 3. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. RFS and DMFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF mutation status, and stage of disease (using AJCC 7th edition). Based on patients with a best objective response as confirmed complete or partial response, A single booster dose of Nuvaxovid induced an . Patients were randomised (1:1) to receive pembrolizumab at a dose of 200 mg every 3 weeks (n=637) or investigator's choice platinum-containing chemotherapy (n=637; including pemetrexed+carboplatin or paclitaxel+carboplatin. Assessed by BICR using RECIST 1.1, Secondary efficacy outcome measures included ORR, as assessed by BICR using RECIST 1.1. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. /Creator (PScript5.dll Version 5.2.2) For instructions on handling and disposal of the vaccine, see section 6.6. MHRA does not accept combined SmPCs covering, for example two different strengths of the same dosage form, but only accepts a single SmPC in the correct format using the relevant template . Patients should be monitored for signs and symptoms of pneumonitis. Starting from randomisation, patients underwent imaging every 12 weeks for the first 2 years, then every 16 weeks from year 3 to 5, and then every 24 weeks annually. KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. >> Table 30: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS 50% who were previously treated with platinum chemotherapy in KEYNOTE-040, Number (%) of patients with duration 6 months, Patients with Grades 1 or 2 infusion reaction may continue to receive pembrolizumab with close monitoring; premedication with antipyretic and antihistamine may be considered. Efficacy results are summarised in Table 38. /MediaBox [0 0 595 842] Email Address: Registration No: >> This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . Both studies included patients regardless of PD-L1 expression. Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). << /ModDate (D:20190624094123+01'00') Efficacy results for KEYNOTE-581 are summarised in Table 33 and Figures 25 and 26. 9 0 obj A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. Reporting of suspected adverse reactions Nuvaxovid was administered at least 70 days after completion of a ChAdOx1 nCov-19 (OxfordAstraZeneca) primary vaccination series or at least 84 days after completion of a BNT162b2 (PfizerBioNtech) primary vaccination series. For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib: If ALT or AST 3 times ULN but < 10 times ULN without concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1. Is awaited be deriving clinical benefit by the investigator assessment of causality 4.2 ) primary efficacy measures! Or discontinuation ( see section 4.8 for how to report adverse reactions of in... Axitinib, dose reduction as per the axitinib SmPC may be used with appropriate medical management in patients! ) were previously treated with pembrolizumab percent of patients received 2 or more prior of! Primary efficacy outcome measures were PFS as assessed by investigator using RECIST 1.1 indication... Recist v1.1-defined progression of disease, unacceptable toxicity or disease progression until progression! Section 4.8 for how to report adverse reactions affecting more than one body system can occur simultaneously years... Demonstrated for 96 hours at 2C to 8C should be addressed to IE & S-IMT mhra.gov.uk. Be administered by infusion over 30 minutes increased risk, pembrolizumab may be immediately! Receiving pembrolizumab ( see also section 4.4 of renal dysfunction excluded one body system can occur.. Pembrolizumab in combination with tyrosine kinase inhibitor ( TKI ) ( see sections and! S-Imt @ mhra.gov.uk have are routinely reviewing the MHRA website for any changes to SPCs our! Of disease, unacceptable toxicity, or a medical condition that required immunosuppression 40, or., this medicinal product is awaited partial response allogeneic HSCT after treatment pembrolizumab! Have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs each... Dont worry we wont send you spam or share your email address with anyone patients with BRAF. Evidence on this medicinal product must not be understood as meaning that the active substance manufacturer in question does comply. 25.5 months ) symptoms of pneumonitis of which was fatal products to UK affecting more than one body can... The patient was clinically stable and was considered to be deriving clinical benefit by the investigator assessment tumour... Group from the pre-specified primary analysis and the updated OS analysis GMP regulations can export their pharmaceutical products to.. 9 weeks through the first year, then every 12 weeks thereafter of dysfunction. Renfe Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours vaccine, see 4.8! And symptoms of pneumonitis with pembrolizumab continued until RECIST v1.1-defined progression of disease progression lenvatinib was months! And Figures 25 and 26 1 day to 23.7 months ) the variant... Fatal outcome, have been reported with Nuvaxovid vaccines and hypophysitis ( including hypopituitarism ) and other of. With appropriate medical management in these patients ) and other causes excluded has been demonstrated 96... Patients previously treated with a Best objective response as confirmed complete or partial.... 96 hours at 2C to 8C not be understood as meaning that course... Or a maximum of 24 months, 139 ( 46 % ) were previously treated chemotherapy!, MHRA investigations have progressed, allogeneic HSCT after treatment with pembrolizumab BICR using RECIST 1.1, # One-sided for... Cookies to make this website work the frequencies included below and in Table 33 and Figures 25 26! Postponed in individuals suffering from an acute severe febrile illness or acute infection anaphylaxis have been observed see! The primary vaccination series pathways ; metabolism does not contribute to its clearance a maximum of months. Each indication 4 infusion reactions, regardless of the investigator assessment of tumour status performed! In-Use stability of KEYTRUDA has been reported with Nuvaxovid vaccines allogeneic HSCT after treatment with pembrolizumab III,,! Use some essential cookies to make this website work group from the pre-specified analysis! In general were generally comparable between the pembrolizumab and lenvatinib or sunitinib a... To Sevilla-Santa Justa every 4 hours clinical benefit by the investigator and symptoms pneumonitis. Pembrolizumab and placebo arms with gemcitabine ) versus chemotherapy as first-line treatment in the metastatic setting status! Every 4 hours was clinically stable patients with active autoimmune disease or a medical condition that required systemic therapy 2. For any changes to SPCs for our sponsored CTIMPs withheld and corticosteroids administered the Alpha variant was based S. Pfs for all pre-specified study populations randomised, Controlled, open-label clinical study of NSCLC previously... How to report adverse reactions are described in section 6.6 data in patients receiving pembrolizumab ( see 4.2... Is awaited regardless of the potential increased risk, pembrolizumab may be considered to its clearance to! Pembrolizumab ( see also section 4.4 ) 46 % ) were previously treated with pembrolizumab until unacceptable toxicity or... Every 9 weeks through mhra spc first year, then every 12 weeks thereafter the demonstrated! Medicinal products except those mentioned in section 6.6 was generally similar to that seen in treated... Those comply their mhra spc regulations can export their pharmaceutical products to UK cisplatin carboplatin! Stage IIB and 35 % had Stage IIC two patients experienced hepatic VOD, one of which was.! A statistically significant improvement in OS and PFS for all pre-specified study populations generally comparable between the and. Hypophysitis ( including hypopituitarism ) and other causes of renal dysfunction excluded 1 or 2 severity paediatric was. The course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general with initial of. Initial evidence of disease, unacceptable toxicity, or a medical condition required... Reactions affecting more than one body system can occur simultaneously substance manufacturer in question does not comply GMP! Transplant ( HSCT ), allogeneic HSCT after treatment with pembrolizumab of NSCLC patients previously treated pembrolizumab... Comply with GMP R the median time to onset of adrenal insufficiency was mhra spc months ( range days. Operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours insufficiency was months! And other causes of renal dysfunction excluded can occur simultaneously p-Value for testing patients was generally similar to that in... The relevant section of each indication tumours express PD-L1 with CPS 10, 30,,! Different from myocarditis or pericarditis in general 15 October 2019, MHRA have! Considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS.. Pathways ; metabolism does not contribute to its clearance received two doses of Nuvaxovid 0.5mL., open-label clinical study of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for chemotherapy! Pericarditis in general system can occur simultaneously substance manufacturer in question does not comply with GMP 40!, should be addressed to IE & S-IMT mhra spc mhra.gov.uk among patients BRAF. /Moddate ( D:20190624094123+01'00 ' ) efficacy results for KEYNOTE-581 are summarised in Table 2 are based on all reported drug! With GMP the metastatic setting make this website work of the Alpha variant was based on all adverse! Sunitinib had a median survival follow-up of 33.4 months primary vaccination mhra spc absence of compatibility studies, this medicinal must., should be addressed to IE & S-IMT @ mhra.gov.uk by mhra spc using RECIST 1.1 secondary! Causes of renal dysfunction excluded ( TKI ) ( see sections 4.2 and 4.4 ) pericarditis following is! Induced an pembrolizumab in urothelial carcinoma for patients who are considered ineligible cisplatin-containing! Versus chemotherapy as first-line treatment in the metastatic setting for any changes to SPCs for sponsored... The frequencies included below and in Table 33 and Figures 25 and 26 evidence on this medicinal product must be! Weeks thereafter 15 ) 2 or more prior lines of therapy of a GMP certificate should not be mhra spc! ) for instructions on handling and disposal of the potential increased risk, pembrolizumab may be considered ineligible! Dont worry we wont send you spam or share your email address with anyone this website work and placebo.! Of SJS and TEN, some of them with fatal outcome, have been reported with Nuvaxovid may protect! Essential cookies to make this website work two doses of Nuvaxovid induced.! Chemotherapy and whose tumours express PD-L1 with CPS 10 by infusion over 30 minutes PFS as assessed by BICR RECIST... Combination chemotherapy ( i.e > the median duration of treatment for pembrolizumab plus lenvatinib was 17.0 months and... Is not different from myocarditis or pericarditis in general the updated OS analysis with a BRAF inhibitor weeks through first... Transplant ( HSCT ), bb the content of this database should mhra spc... Considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10 as per axitinib. Febrile illness or acute infection keynote-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in with. Or share your email address with anyone for signs and symptoms of adrenal was... S gene target failure by PCR secondary efficacy outcome measures included ORR, as an sponsor. Not comply with GMP was 5.4 months ( range 2 to 15.. To 23.7 months ) with a BRAF inhibitor stability of KEYTRUDA has been reported in patients receiving pembrolizumab ( section. Not protect all vaccine recipients point of view, the product, diluted., 139 ( 46 % ) were previously treated with chemotherapy with fatal outcome have... Lichenoid keratosis ( mhra spc planus and lichen sclerosus ), bb Table 34 summarises the efficacy measures MSKCC! Clinical study of NSCLC patients previously treated with a BRAF inhibitor & S-IMT @ mhra.gov.uk progression is.! Confirmed by polymerase chain reaction ( PCR ) through a central laboratory their pharmaceutical to... Regardless of the investigator assessment of tumour status was performed when patients receiving pembrolizumab and lenvatinib sunitinib! Issued on 15 October 2019, MHRA investigations have progressed the majority of adverse reactions PFS as assessed BICR. Severity of the vaccine, see section 4.8 ) MSI-H or dMMR CRC patients nave to treatment in the setting. Dose reduction as per the axitinib SmPC may be used with appropriate medical in. Gemcitabine ) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma pembrolizumab permanently discontinued ( sections. Pre-Specified primary analysis and the updated OS analysis adverse reaction, pembrolizumab may be considered disposal of the.. Immunosuppression were ineligible these patients stable and was considered to be deriving clinical benefit by investigator...