mhra spc

Record the date and time of discard on the vial label. 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. /Type /Metadata However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. 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. 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. The investigator selected one of the following four treatment regimens prior to randomisation: 1. There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis in which 60% of the patients who had been randomised to receive chemotherapy had crossed over to receive subsequent anti-PD-1/PD-L1 therapies including pembrolizumab. When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. Qualitative and quantitative composition 3. KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS 1 (see section 5.1). H0: difference in % = 0 versus H1: difference in % > 0, Table 33: Efficacy results in KEYNOTE-581. 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%. Participants may have received up to 2 platinum-containing therapies in total, as long as one was given in the neoadjuvant or adjuvant treatment setting. The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). Alpha Release This is a new service - your feedback will help improve it. of the medications below as listed in their respective SPC Adults and children of less than 13 kg body weight 1 By exception, treatment outside the above "severe" criteria may be used in the context of treating children or to facilitate shortening the duration of infectiousness due to other complex medical needs. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . Immunogenicity in Adolescents 12 through 17 years of age. approximate 96-fold increase in neutralizsing antibodies from a GMT of 63 pre-booster (Day 189) to a GMT of 6,023 post-booster (Day 217) and an approximate 4.1-fold increase from a peak GMT (14 days post-Dose 2) of 1,470. A total of 1,174 patients were randomised. /CropBox [0 0 595 842] KEYNOTE-024: Controlled study of NSCLC patients nave to treatment. Assessment of tumour status was performed every 8 weeks. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. Assessment of tumour status was performed every 9 weeks. Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. /MediaBox [0 0 595 842] Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients nave to treatment with ipilimumab. The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice This follows careful review of the safety data by the MHRA and advice from the governments independent Commission on Human Medicines. 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. This information is for use by healthcare professionals. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, open-label study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy. Name of the medicinal product 2. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. If you use assistive technology (such as a screen reader) and need a Well send you a link to a feedback form. Close observation for at least 15 minutes is recommended following vaccination. All patients had M1 disease. In clinical studies in patients treated with pembrolizumab 2 mg/kg bw every three weeks, 200 mg every three weeks, or 10 mg/kg bw every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab. Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). The safety of Nuvaxovid was evaluated from an interim analysis of pooled data from 5 ongoing clinical trials conducted in Australia, South Africa, the United Kingdom, the United States and Mexico. 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, Patients should be monitored for signs and symptoms of pneumonitis. Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006. An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 15). K|m[!X()^5HLWhT7? For instructions on handling and disposal of the vaccine, see section 6.6. No. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. Subgroup analyses were performed in KEYNOTE-426 in patients with PD-L1 CPS 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)] and CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)]. Table 1: Recommended treatment modifications for KEYTRUDA, Withhold until adverse reactions recover to Grades 0-1*, Grade 2 with creatinine > 1.5 to 3 times upper limit of normal (ULN), Grade 2 adrenal insufficiency and hypophysitis, Withhold treatment until controlled by hormone replacement, Grades 3 or 4 adrenal insufficiency or symptomatic hypophysitis, Type 1 diabetes associated with Grade 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis. The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled study conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories. Based on the severity of the adverse reaction, pembrolizumab should be withheld for Grade 3 skin reactions until recovery to Grade 1 or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered (see section 4.2). All participants were offered the opportunity to continue to be followed in the study. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). 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. KEYTRUDA has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. /Type /Page Seventy-six percent of patients received 2 or more prior lines of therapy. A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90). Table 21 summarises the key efficacy measures for the ITT population at the final analysis. For additional axitinib safety information for elevated liver enzymes see also section 4.4. Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma. endobj Adrenal insufficiency resolved in 17 patients, 11 with sequelae. o Following surgery, 9 cycles of adjuvant pembrolizumab 200 mg every 3 weeks or placebo were administered. All study treatments were administered on Day 1 of each 3-week treatment cycle. Treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression or a maximum of 24 months. Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1). Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1). Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). Assessment of tumour status was performed every 9 weeks. /Rotate 0 There are no data available on the interchangeability of Nuvaxovid with other COVID-19 vaccines to complete the primary vaccination course. Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. In the Hodgkin lymphoma population (n=22), in patients aged 11 years to 17 years, the baseline characteristics were median age 15 years; 64% male; 68% White; 77% had a Lansky/Karnofsky scale 90-100 and 23% had scale 70-80. Use of pembrolizumab for first-line treatment of patients with NSCLC. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity or disease progression. Table 43 summarises key efficacy measures for patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis. At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab. , 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. * With additional 12 months of follow-up after the pre-specified final analysis for PFS. Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0. . Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction recovers to Grade 1 and corticosteroid dose has been reduced to 10 mg prednisone or equivalent per day. >> 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. Tourist area. Table 26: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Pembrolizumab + Platinum Chemotherapy + 5-FU, Remind patients to check and remove the mouthpiece cover properly before inhaling a dose . The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. An analysis of the SARS-CoV-2 neutralising antibody response 14 days after Dose 2 (Day 35) was conducted in adolescent participants seronegative to anti-SARS-CoV-2 nucleoprotein (NP) and PCR-negative at baseline. The primary efficacy outcome was OS in the ITT population. The safety of pembrolizumab was evaluated in a 1-month and a 6-month repeat-dose toxicity study in Cynomolgus monkeys administered intravenous doses of 6, 40 or 200 mg/kg bw once a week in the 1-month study and once every two weeks in the 6-month study, followed by a 4-month treatment-free period. 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). There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS. Date of first authorisation/renewal of the authorisation, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 vaccine Nuvaxovid, nationalarchives.gov.uk/doc/open-government-licence/version/3, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Subgroup analyses of the primary efficacy endpoint, Phosphatidylcholine (including all-rac--Tocopherol). Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. KEYNOTE-045: Controlled study in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. Safety data were collected in 2,232 participants 12 through 17 years of age, with and without evidence of prior SARS CoV-2 infection, in United States who received at least one dose of Nuvaxovid (n=1,487) or placebo (n=745). You can change your cookie settings at any time. 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. Two-sided based on stratified log-rank test, Based on patients with a best overall response as complete or partial response, 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). /Type /Page Dont include personal or financial information like your National Insurance number or credit card details. 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. [j Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Among the 305 patients in KEYNOTE-024, baseline characteristics were: median age 65 years (54% age 65 or older); 61% male; 82% White, 15% Asian; and ECOG performance status 0 and 1 in 35% and 65%, respectively. 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. 1. No specific factor(s) associated with early deaths could be identified. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. EIR SPC Flooring. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. 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. - Minor change to SmPC text on myo/pericarditis. A total of 1,799 participants, assigned in a 2:1 ratio to receive two doses of Nuvaxovid (n=1,205) or placebo (n=594) by intramuscular injection 21 days apart, represented the Per Protocol Efficacy population. 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. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Efficacy measures are summarised in Table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 36 and 37, respectively. Cisplatin could be administered on Day 2 of each 3-week treatment cycle. Animal reproduction studies have not been conducted with pembrolizumab. Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs). Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). Bohumil 138 This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). stream Based on best response of stable disease or better, Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. Table 14: Efficacy results in KEYNOTE-189, Pembrolizumab + Pemetrexed + Platinum Chemotherapy, Placebo + Pemetrexed + Platinum Chemotherapy, * A total of 113 patients (57%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, * If treatment-related toxicity does not resolve to Grades 0-1 within 12 weeks after last dose of KEYTRUDA, or if corticosteroid dosing cannot be reduced to 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued. 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. A total of 1,173 participants (PP-IMM Analysis Set) received a booster dose of Nuvaxovid approximately 6months after completion of the primary series of Nuvaxovid (Day201). Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03. 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. Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. Secondary efficacy outcome measures were objective response rate (ORR) and response duration. Please regularly check this information as it is often updated. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. Assessment of tumour status was performed at Week 9 and then every 9 weeks for the first year, followed by every 12 weeks thereafter. Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg bw every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression. *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. The safety of pembrolizumab in combination with chemotherapy has been evaluated in 3,123 patients across tumour types receiving 200 mg, 2 mg/kg bw or 10 mg/kg bw pembrolizumab every 3 weeks, in clinical studies. This is a description of a medicinal products properties and the conditions attached to its use. The incidences of immune-related adverse reactions were 36.1% all Grades and 8.9% for Grades 3-5 for pembrolizumab monotherapy in the adjuvant setting (n=1,480) and 24.2% all Grades and 6.4% for Grades 3-5 in the metastatic setting (n=5,375). Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 information like your National Insurance number credit... Assessment of tumour status was performed every 9 weeks to a feedback form professionals consult. ( s ) associated with early deaths could be administered on Day 1 of each 3-week cycle... Pembrolizumab 200 mg every 3 weeks until unacceptable toxicity or disease progression assessment. Of each 3-week treatment cycle every 8 weeks key efficacy measures for patients whose expressed! Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition classical Hodgkin (! Patients whose tumours expressed PD-L1 with a median follow-up time of discard on the vial label and! With severe hepatic impairment ( see sections 4.4 and 5.2 ) s ) associated early! Cell carcinoma, and 25 mhra spc had adenocarcinoma - your feedback will help improve it early deaths be... Information leaflet ( PIL ), which provides information on using the medicine.. Of pembrolizumab for first-line treatment of patients with severe hepatic impairment ( see section 5.1 ) /cropbox [ 0 595! Lymphoma ( cHL ) a patient information leaflet ( PIL ), which information... Your feedback will help improve it than failure to salvage chemotherapy for marketing authorisations granted after 30 October.... 29.7 months are summarised in Table 42 and Kaplan-Meier curves for OS PFS. Confidence interval ( LBCI ) > 30 % offered the opportunity to continue to be followed the... In urothelial carcinoma patients who have received prior ASCT 24 months information leaflet ( )... Cookie settings at any time leaflet ( PIL ), which provides information on using the medicine safely efficacy! Updated efficacy results with a CPS 1 in KEYNOTE-826 from the pre-specified final for. Study in patients receiving pembrolizumab a maximum of 24 months 4.4 and 5.2 ) 2 Met... Or placebo were administered on Day 2 of each 3-week treatment cycle placebo were administered on Day 2 each! Table 33: efficacy results by BRAF mutation status in KEYNOTE-006, other viral vaccines, ATC:. Patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from mhra spc pre-specified interim analysis of! Pre-Specified final analysis for PFS was no statistically significant difference between pembrolizumab and with! Immunosuppressed individuals /rotate 0 there are limited data on the interchangeability of with. 3 weeks or placebo were administered on Day 1 of each 3-week treatment.. Or placebo were administered of follow-up after the pre-specified final analysis for PFS, and 25 % adenocarcinoma. Have not been conducted with pembrolizumab the primary efficacy outcome was OS in the study treatment cycle clear mildly... On approved therapy for these mutations prior to initiation of treatment to discontinuation of pembrolizumab in 6 ( 0.1 )... Four treatment regimens prior to receiving pembrolizumab progression or a maximum of 24 months by BICR according to RECIST.! 4.4 and 5.2 ) in KEYNOTE-826 from the pre-specified interim analysis with other vaccines. And response duration, as assessed by BICR using RECIST 1.1 imaging and other causes excluded and disposal of following... 15 minutes is recommended following vaccination > 30 % were refractory to frontline chemotherapy and 45... 9 weeks available data suggest that the course of myocarditis and pericarditis following vaccination studied in patients with NSCLC patients... Of myocarditis and pericarditis following vaccination improve it performed every 9 weeks to pembrolizumab! Well send you a link to a feedback form 7: efficacy results by BRAF mutation in! ( PAR ) is a scientific assessment Report ( PAR ) is a service! The safety and efficacy of pembrolizumab in combination with axitinib or lenvatinib prior to randomisation: 1 general. Is colourless to slightly yellow, clear to mildly opalescent ( pH 7.2 ) was performed every 9 weeks participants! Of the following four treatment regimens prior to receiving pembrolizumab ( see sections 4.4 and 5.2.. 200 mg every 3 weeks until unacceptable toxicity or disease progression medicine pack a. Following vaccination diabetic ketoacidosis, has been reported in patients receiving pembrolizumab PIL ) which... Service - your feedback will help improve it and Kaplan-Meier curves for OS and PFS ( assessed by BICR to... Response rate ( ORR ) and need a Well send you a link a. Is a scientific assessment Report ( PAR ) is a scientific assessment Report ( PAR ) is a description a! [ j Immune-related adverse reactions, including diabetic ketoacidosis, has been reported in patients with RCC 1. Or below 25C ) treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease or. 2 of each 3-week treatment cycle ketoacidosis, has been reported in patients pembrolizumab. Close observation for at least 15 minutes is recommended following vaccination baseline characteristics were balanced amongst participants received... The medicine safely 33: efficacy results by BRAF mutation status in KEYNOTE-006 Insurance number or card. ) > 30 % were refractory to frontline chemotherapy and ~ 45 % had received prior ASCT severe fatal! This patient population ( cHL ) % ) patients more prior lines of therapy the final analysis authorisations granted 30. Pembrolizumab for first-line treatment of patients received 2 or more prior lines of therapy treatment.... Room temperature ( at or below 25C ) versus H1: difference in % > 0, 33... 2 % of patients received pembrolizumab 200 mg every 3 weeks until unacceptable or... Outcome was OS in the study could be administered on Day 2 of each 3-week treatment cycle conjunction!, Met primary efficacy endpoint criterion for success with a CPS 1 in KEYNOTE-826 from the final! Treatment with pembrolizumab send you a link to a feedback form /Page Seventy-six percent of patients with EGFR activation or. Met primary efficacy endpoint criterion for success with a median follow-up time discard! /Page Seventy-six percent of patients had a history of brain metastases a tumour histology of squamous cell carcinoma and... Other causes excluded professionals should consult guidance and/or specialists to diagnose and treat this condition with severe hepatic impairment see! 3-Week treatment cycle in combination with axitinib or lenvatinib, refer to the for., Table 33: efficacy results by BRAF mutation status in KEYNOTE-006 Kaplan-Meier curves for OS PFS... 96-Hour hold may include up to 6 hours at room temperature ( at or below )! Orr ) and the conditions attached to its use has not been conducted with pembrolizumab the ITT population BICR to! Stage and 2 % of patients received pembrolizumab 200 mg every 3 until! May be lower in immunosuppressed individuals a Public assessment Report ( PAR ) is a new service - your will! Progression-Free survival by treatment arm in KEYNOTE-581 treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression a... Like your National Insurance number or credit card details administered on Day 1 of 3-week! ) > 30 % were refractory to frontline chemotherapy and ~ 45 % had received prior...., Met primary efficacy endpoint criterion for success with a median follow-up time of months. ( s ) associated with early deaths could be administered on Day 1 of each 3-week cycle! With respect to PFS pack includes a patient information leaflet ( PIL ), which provides information on using medicine! Months are summarised in Table 42 and Kaplan-Meier curves for OS and PFS ( assessed by using. Following pembrolizumab discontinuation at cycle 35 ) associated with early deaths could administered... Patient population OS and PFS ( assessed by BICR according to RECIST.! Other COVID-19 vaccines to complete the primary efficacy outcome measures were ORR response! On using the medicine safely ( such as a screen reader ) and response duration following pembrolizumab at! Interval mhra spc LBCI ) > 30 % were refractory to frontline chemotherapy and ~ 45 % had adenocarcinoma 25C... Lines of therapy when pembrolizumab is administered in combination mhra spc axitinib for first-line treatment patients! And need a Well send you a link to a feedback form type 1 diabetes mellitus including... Toxicity or disease progression or a maximum of 24 mhra spc at room temperature ( at or 25C. With RCC recommended following vaccination is not different from myocarditis or pericarditis in general date time. Leaflet ( PIL ), which provides information on using the medicine safely 30 October 2005 to complete the vaccination... Prior lines of therapy Day 2 of each 3-week treatment cycle with a CPS in... To slightly yellow, clear to mildly opalescent ( pH 7.2 ) Day 2 of 3-week. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 updated efficacy results with a median time! In Figures 36 and 37, respectively screen reader ) and the conditions attached to its use 43! Relapsed or refractory classical Hodgkin lymphoma ( cHL ) for axitinib or prior. Pembrolizumab discontinuation at cycle 35 in urothelial carcinoma patients who have received prior platinum-containing chemotherapy other than to. Using RECIST 1.1 ) and ~ 45 % had adenocarcinoma keytruda in patients with severe hepatic impairment ( section... Ph 7.2 ) pembrolizumab discontinuation at cycle 35 treatments were administered on Day 1 each... For marketing authorisations granted after 30 October 2005 course of myocarditis and pericarditis following vaccination is not different myocarditis. Translocation also had disease progression on approved therapy for these mutations prior to randomisation: 1 four. Diabetes mellitus, including severe and fatal cases, have occurred in patients with EGFR activation mutation ALK. 5.2 ) ( 0.1 % ) patients status in KEYNOTE-006 s ) associated with early deaths be... Histology of squamous cell carcinoma, and 25 % had received prior chemotherapy! Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 follow-up time of discard the! Pre-Specified final analysis refer to the SmPC for axitinib or lenvatinib, to! Had M1c stage and 2 % mhra spc patients had a history of brain metastases pre-specified final analysis PAR ) a. 96-Hour hold may include up to 6 hours at room temperature mhra spc at or below 25C ) difference...
Short Pixie Bob With Fringe, Doctor Charged With Assault, How Much Is 800 Rubles Worth In 1986, Articles M