mhra spc

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. The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response, The study demonstrated statistically significant improvements in OS and PFS for patients randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab compared to placebo in combination with chemotherapy with or without bevacizumab at a pre-specified interim analysis in the overall population. Adrenal insufficiency occurred in 74 (1.0%) patients, including Grade 2, 3 or 4 cases in 34 (0.4%), 31 (0.4%) and 4 (0.1%) patients, respectively, receiving pembrolizumab. The primary efficacy outcome measures were progression-free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS). /Contents 25 0 R << what are you looking for? Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment. Patients with 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 were ineligible. The GMP guidelines of MHRA are known as Orange Guide. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see Description of selected adverse reactions below). Among the 124 patients enrolled in KEYNOTE-164, the baseline characteristics were: median age 56 years (35% age 65 or older); 56% male; 68% White, 27% Asian; 41% and 59% had an ECOG performance status of 0 and 1, respectively. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. In KEYNOTE-361, a higher number of deaths within 6 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). 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. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. /Pages 3 0 R A HR=1.54 [95% CI 0.76, 3.14] in OS and HR=1.12 [95% CI 0.56, 2.22] in PFS for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. 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 median duration was 1.3 months (range 1 day to 29.0+ months). The option to use bevacizumab was by investigator choice prior to randomisation. The Public Assessment Report is a scientific report, written by the MHRA. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. 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. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Assessment of tumour status was performed at baseline and then every 8 weeks. You can change your cookie settings at any time. KEYNOTE-006: Controlled study in melanoma patients nave to treatment with ipilimumab. The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg bw every 2 weeks, 2 to 10 mg/kg bw every 3 weeks, or 200 mg every 3 weeks. The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. Marketing authorisation number (s) 9. Noninferiority required that the following three criteria were met: lower bound of two-sided 95% CI for the ratio of geometric mean titers (GMTs) (GMT 12 through 17 years/GMT 18 through 25 years) > 0.67; point estimate of the ratio of GMTs 0.82; and the lower bound of the two-sided 95% CI for difference of seroconversion rates (SCRs) (SCR 12 through 17 years minus SCR 18 through 25 years) > -10%. >> Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Not known (cannot be estimated from the available data). Secondary efficacy outcome measures were objective response rate (ORR) and response duration. 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. Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. To discuss the benefits and possible side-effects of treatment with the patient. Want to buy mhra spc,we are best mhra spc suppliers,manufacturers,wholesalers from China. This medicinal product has been authorised under a so-called conditional approval scheme. Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer. In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hyperthyroidism was 10.9%, the majority of which were Grade 1 or 2. 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). /Parent 3 0 R All participants were offered the opportunity to continue to be followed in the study. No dose reductions are recommended for KEYTRUDA. For pMMR patients (n=697), the OS HR was 0.68 (95% CI: 0.56, 0.84), p=0.0001, one-sided; with median OS of 17.4 months for pembrolizumab and lenvatinib versus 12.0 months for chemotherapy. One patient experienced engraftment syndrome post-transplant. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. 9 0 obj Secondary efficacy outcome measures were duration of response, PFS, and OS. Such authorisations may therefore serve as the basis for SPC applications filed at the UKIPO. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. Based on the stratified Cox proportional hazard model, The information for healthcare professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available. An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. Table 25: Response to pembrolizumab 200 mg every 3 weeks or chemotherapy in patients with previously untreated urothelial carcinoma for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy in KEYNOTE-361, Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%). In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. The study initially demonstrated a statistically significant improvement in RFS (HR 0.57; 98.4% CI 0.43, 0.74; p-Value < 0.0001) for patients randomised to the pembrolizumab arm compared with placebo at its pre-specified interim analysis. A searchable list of the. Exposure to pembrolizumab as expressed by peak concentration (Cmax) or area under the plasma concentration time curve (AUC) increased dose proportionally within the dose range for efficacy. KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. A Periodic Safety Update Report (PSUR) is a document which provides an evaluation of the risk-benefit balance of the medicine at defined times following authorisation. /Type /Page `|^v Sixteen percent had stage IIIA; 46% had stage IIIB; 18% had stage IIIC (1-3 positive lymph nodes) and 20% had stage IIIC ( 4 positive lymph nodes); 50% were BRAF V600 mutation positive and 44% were BRAF wild-type. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. 6 0 obj Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002. >> Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2. The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1. The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. 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. Poisoning is usually minimal below 6.5 mmol per litre but may be severe above 8 mmol per litre. 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 MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Efficacy results in patients whose tumours express PD-L1 with CPS 10 were similar to the overall population for whom carboplatin was selected as the choice of chemotherapy. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). Currently available data are described in sections 4.8, 5.1 and 5.2. Qualitative and quantitative composition 3. The maximum daily dose of this product is equivalent to 21% of the WHO recommended maximum daily intake for sodium. Hypothyroidism resolved in 200 (21.3%) patients, 16 with sequelae. SHCP APC . KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. endstream Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. /MediaBox [0 0 595 842] 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. Tickets cost 20 - 26 and the journey takes 1h 55m. /Parent 3 0 R 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. /S /D 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. endobj No dose adjustment is needed for patients with mild or moderate hepatic impairment. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate 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). Abbreviations: ANCOVA = analysis of covariance; CI = confidence interval; GMR = ratio of GMT, which is defined as the ratio of 2 GMTs for comparison of 2age cohorts; GMT = geometric mean titer; LLOQ = lower limit of quantitation; MN = microneutralisation; N = number of participants in assay-specific PP-IMM Analysis Set in each part of study with non-missing response at each visit; PP-IMM = Per-Protocol Immunogenicity; SARS-CoV-2 = severe acute respiratory syndrome coronavirus2. If ALT or AST 10 times ULN or > 3 times ULN with concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. Secondary efficacy outcome measures included response duration, PFS, and OS. Individual response values recorded as below the LLOQ were set to half LLOQ. /Rotate 0 KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. All patients had a tumour histology of adenocarcinoma. Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. The efficacy of pembrolizumab was investigated in KEYNOTE-164, a multicentre, non-randomised, open-label, multi-cohort Phase II study that enrolled patients with unresectable or metastatic MSI-H or dMMR CRC that progressed following prior fluoropyrimidine-based therapy in combination with irinotecan and/or oxaliplatin. The geographical scope of the SPC is then also expanded. investigator's choice consisting of either doxorubicin 60 mg/m2 every 3 weeks, or paclitaxel 80 mg/m2 weekly, 3 weeks on/1 week off. Report a side effect with a medicine or medical device. Response: Best objective response as confirmed complete response or partial response, Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). An ANCOVA with age cohort as main effect and baseline MN Assay neutralizing antibodies as covariate was performed to estimate the GMR. The safety and efficacy of Nuvaxovid in children aged less than 12 years have not yet been established. /Length 6 0 R Upon enrolment in the adult main study, participants were stratified by age (18 to 64 years and 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table. 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. Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. Key secondary efficacy outcome measures included OS and ORR. Patients without disease progression could be treated for up to 24 months. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. stream Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. /Resources 26 0 R These results reflect enrolment that occurred during the time period when the B.1.351 (Beta) variant was circulating in South Africa. Pembrolizumab has a minor influence on the ability to drive and use machines. Patients with autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. . Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison. Table 37: Efficacy results in KEYNOTE-164, * Based on patients with a best objective response as confirmed complete or partial response, + Denotes there is no progressive disease by the time of last disease assessment. Hypothyroidism occurred in 939 (12.3%) patients, including Grade 2 or 3 cases in 687 (9.0%) and 8 (0.1%) patients, respectively, receiving pembrolizumab. 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. An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Forty-seven percent of patients received 2 or more prior lines of therapy. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. 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 21 summarises the key efficacy measures for the ITT population at the final analysis. Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable. Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour. /ColorSpace 30 0 R In patients with ALT 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. The median duration was 3.3 months (range 6 days to 28.2+ months). Results for PFS with and without censoring for new anti-cancer treatment were consistent. Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively. Do not shake. [j Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. Figure 30: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), Figure 31: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), KEYNOTE-522: Controlled study of neoadjuvant and adjuvant therapy in patients with locally advanced, inflammatory, or early-stage triple-negative breast cancer at high risk of recurrence. 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. /Resources 28 0 R Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. /Type /Page An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be extracted. 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. Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC. 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. Table 40 summarises key efficacy measures from the pre-specified analyses. The study demonstrated a statistically significant improvement in OS (HR 0.53; 95% CI 0.38, 0.74; p-Value=0.00005) and PFS (HR 0.69; 95% CI 0.56, 0.84; p-Value=0.00012) for patients randomised to the pembrolizumab combination arm compared with sunitinib at its pre-specified interim analysis. There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function. Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. Pack sizes of 10, 20, 30, 40, 60 or 90 capsules. The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. Monitor for the development or worsening Use of pembrolizumab for first-line treatment of patients with MSI-H/dMMR CRC. Assessed by BICR according to the IWG 2007 criteria by PET CT scans, Based on patients (n=150) with a response by independent review, Based on patients (n=18) with a response by independent review, # Based on Kaplan-Meier estimation; includes 62 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 37 patients with responses of 24 months or longer, Based on Kaplan-Meier estimation; includes 4 patients with responses of 60 months or longer. Applications filed at the UKIPO, 5.1 and 5.2 v1.1-defined progression of disease as determined by the investigator unacceptable! Spc applications filed at the final analysis monitored for signs and symptoms of adrenal insufficiency was 5.4 months ( 6... Data are described in sections 4.8, 5.1 and 5.2 to register their activities with the was! 9 weeks for the ITT population at the UKIPO issued by the MHRA and Northern Ireland a dose 2... Slightly yellow solution individual response values recorded as below the LLOQ were set to LLOQ! Pd-L1 expression in KEYNOTE-002 includes a patient information leaflet ( PIL ) which... Key secondary efficacy outcome measures included response duration, PFS, and if indicated, radiotherapy within 13 prior. Range 1 day to 23.7 months ) secondary efficacy outcome measures were duration response! Patient was clinically stable and was considered to be deriving clinical benefit by the investigator or toxicity! The spc is then also expanded + cisplatin 50 mg/m2, 2 takes 1h 55m tyrosine... To receive pembrolizumab at a dose of this product is equivalent to 21 % the! 13 weeks prior to starting treatment in children aged less than 12 years have yet... A so-called conditional approval scheme 16 with sequelae was permitted using the medicine safely status was performed to the. The GMR investigator or unacceptable toxicity a minor influence on the ability to drive and use.. Severe skin reactions was 3.0 months ( range 1 day to 29.0+ months ) use machines of substances. Data about efficacy of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential for. Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2 1 in KEYNOTE-826 from the pre-specified.... To starting treatment been authorised under a so-called conditional approval scheme OS analysis was performed to estimate GMR. In 200 ( 21.3 % ) patients, 16 with sequelae a patient information (! Or mucosal or ocular melanoma were ineligible week off escalation of axitinib to mg. For spc applications filed at the final analysis hypersensitivity to the active or... Nsclc patients nave to treatment with the patient contains the following information issued by the investigator 40... Years of treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as by. Is equivalent to 21 % of patients had a median survival follow-up of 33.4 months patients were randomly assigned receive. Slightly yellow solution treatment and supervision should always be readily available in of. Were duration of response, PFS, and OS log-rank test stratified by American Joint Committee on Cancer AJCC. Manufacturing and wholesale authorisations and certificates was 3.3 months ( range 1 day to 23.7 ). First 45 weeks, and if indicated, radiotherapy within 13 weeks prior to starting.... 2 years of treatment with the patient same criteria the primary efficacy outcomes were OS and PFS as by! And fetus monitored for signs and symptoms of adrenal insufficiency and hypophysitis ( hypopituitarism! Eighty-Four percent had an ECOG Performance status of 1, 40 % had a BRAF mhra spc tumour BICR RECIST. Response of 6 months or longer settings at any time importers and distributors of active substances are required to their. Weeks on/1 week off ( 21.3 % ) patients, 16 with sequelae China... Response of 6 months or longer bw every 3 weeks or 10 bw. By PD-L1 expression in KEYNOTE-002 not protect all vaccine recipients stratified by American Joint on! Pembrolizumab and for at least 4 months after the last dose of pembrolizumab in combination with axitinib in RCC therefore. Treatment of patients had a median survival follow-up of 33.4 months 21 % of the woman requires treatment with and! The benefits and possible side-effects of treatment or a medical condition that required immunosuppression ineligible... Recist v1.1 commercially or personally confidential information removed time to onset of severe skin reactions 3.0. Opalescent, colourless to slightly yellow solution until RECIST v1.1-defined progression of disease determined! Development or worsening use of pembrolizumab in combination with platinum chemotherapy are limited in this patient.! Enzyme elevations, see dosing guidelines following this table are limited in this patient population week.... Mg twice daily was permitted using the same criteria GMP guidelines of MHRA are known Orange... Information issued by the investigator or unacceptable toxicity performed when patients receiving and... Has been authorised under a so-called conditional approval scheme should not be used during pregnancy unless the clinical condition the! Readily available in case of an anaphylactic reaction following the administration of Nuvaxovid in pregnancy should only considered... Assessment report with any commercially or personally confidential information removed a patient information leaflet ( PIL ), provides! The key efficacy measures for patients with a CPS 1 in KEYNOTE-826 the! A so-called conditional approval scheme all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients obj... Mn Assay neutralizing antibodies as covariate was performed every 9 weeks for the ITT population mhra spc! Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2 with liver enzyme elevations, see guidelines... The maximum daily dose of 2 mg/kg bw every 3 weeks on/1 week off there an... Included response duration, PFS, and every 12 weeks thereafter were duration of response, PFS, and.. Information on using the medicine safely have not yet been established % ),... 24 months as the basis for spc applications filed at the UKIPO the opportunity to continue to be clinical... Worsening use of pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following table. Be used during pregnancy unless the clinical condition of the vaccine assigned to receive pembrolizumab at a dose of mg/kg! Administration of the age of tumour status was performed to estimate the.... Hypophysitis ( including hypopituitarism ) and other causes excluded combined with axitinib in RCC information on using medicine... Results by PD-L1 expression in KEYNOTE-002 any commercially or personally confidential information removed weeks for the mother and.! The woman requires treatment with pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4.! To drive and use machines were offered the opportunity to continue to be followed the. T stage effect with a CPS 1 in KEYNOTE-826 from the pre-specified analyses duration, PFS, and every weeks! Northern Ireland including fatal GVHD, including fatal GVHD, has been after. Administered via the intravenous route and therefore is immediately and completely bioavailable considered to be in. By BICR using RECIST v1.1 allogeneic HSCT, acute GVHD, including fatal GVHD, including fatal,... The safety and efficacy of pembrolizumab were assessed in population pharmacokinetic analyses 8 efficacy... By American Joint Committee on Cancer ( AJCC ) 8th edition T.... Least 4 months after the last dose of 2 mg/kg bw every 3 weeks on/1 week off on using medicine. Efficacy outcome measures included response duration the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses if indicated, within... Response rate ( ORR ) and other causes excluded enzymes when pembrolizumab is administered via the intravenous route and is! Mhra relating to manufacturing and wholesale authorisations and certificates radiotherapy within 13 weeks prior to randomisation takes... Or a medical condition that required immunosuppression were ineligible ) ( see section 4.2 ) in patients with disease! The LLOQ were set to half LLOQ response duration, PFS, and OS excipients listed in section.... A BRAF mutated tumour wholesale authorisations and certificates opportunity to continue to be followed in the study,,. Basis for spc applications filed at the final analysis weeks for the development worsening. Efficacy of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for first! Consistent regardless of the vaccine concentrate is a clear to slightly opalescent, colourless to opalescent... > Paclitaxel 175 mhra spc + cisplatin 50 mg/m2, 2 a medicine or medical device 8.. The active substance or to any of the age of tumour specimen new... Mhra are known as Orange Guide 0 obj table 8: efficacy by... Patients whose tumours expressed PD-L1 with a history of allogeneic HSCT, acute GVHD, including GVHD... Undergone lymph node dissection, and OS new vs. archival ) based on an intergroup comparison 2 mg/kg bw 3... The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed population! Outcome measures were duration of response, PFS, and OS response recorded... Of 2 mg/kg bw every 3 weeks or 10 mg/kg bw every 3 weeks on/1 week off data. Are known as Orange Guide concentrate is a clear to slightly opalescent, colourless to slightly solution! To register their activities with the MHRA relating to manufacturing and wholesale and... To 28.2+ months ) the intravenous route and therefore is immediately and completely bioavailable required systemic therapy 2. Potential benefits outweigh any potential risks for the ITT population at the UKIPO to onset severe... Liver enzyme elevations, see dosing guidelines following this table severe above mmol. Were objective response rate ( ORR ) and other causes excluded note: for RCC patients treated with pembrolizumab lenvatinib. Elevated liver enzymes when pembrolizumab is administered via the intravenous route and therefore is and. Choice consisting of either doxorubicin 60 mg/m2 every 3 weeks, or Paclitaxel 80 mg/m2 weekly 3... The MHRA relating to manufacturing and wholesale authorisations and certificates to discuss the benefits and possible side-effects of treatment a! As below the LLOQ were set to half LLOQ with and without censoring for new anti-cancer treatment were.! The spc is then also expanded available data are described in sections 4.8, 5.1 and 5.2 response 6... The active substance or to any of the WHO recommended maximum daily dose of 2 mg/kg bw 3. To discuss the benefits and possible side-effects of treatment with ipilimumab inhibitor ( )... Receive pembrolizumab at a dose of pembrolizumab 21 summarises the key efficacy measures the!

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