. A total of 307 patients were enrolled and randomised to pembrolizumab (n=153) or chemotherapy (n=154). 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. Based on Miettinen and Nurminen method stratified by MMR Status, ECOG performance status, geographic region, and history of pelvic radiation, Figure 36: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-775 (intent to treat population), Figure 37: Kaplan-Meier curve for progression free-survival by treatment arm in KEYNOTE-775 (intent to treat population). This information is for use by healthcare professionals. In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis. Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually. Within the group assigned to receive Nuvaxovid, 115 participants received a two-dose primary series of ChAdOx1 nCov-19 and 114 participants received a two-dose primary series of BNT162b2, prior to receiving a single booster dose (0.5 mL) of Nuvaxovid. 4 mL of concentrate in a 10 mL Type I clear glass vial, with a coated grey chlorobutyl or bromobutyl stopper and an aluminium seal with a dark blue coloured flip-off cap, containing 100 mg pembrolizumab. 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. In patients with CRC treated with pembrolizumab as monotherapy (n=153), the incidence of colitis was 6.5% (all Grades) with 2.0% Grade 3 and 1.3% Grade 4. Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated. Randomisation was stratified by chemotherapy treatment (paclitaxel or nab-paclitaxel vs. gemcitabine and carboplatin), tumour PD-L1 expression (CPS 1 vs. CPS < 1), and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). 15 0 obj Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases. Continue typing to refine. Secondary efficacy outcome measures included response duration, PFS, and OS. 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. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. The study design was similar to that of KEYNOTE-024, except that patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. Assessment of tumour status was performed every 9 weeks. For efficacy data in patients 75 years of age please refer to the relevant section of each indication. SHCP APC . Key secondary efficacy outcome measures included OS and ORR. It will take only 2 minutes to fill in. No patients experienced hepatic VOD. Among these 548 enrolled patients with tumours expressing PD-L1, 273 patients were randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab, and 275 patients were randomised to placebo in combination with chemotherapy with or without bevacizumab. To help us improve GOV.UK, wed like to know more about your visit today. Working together across Sussex. When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. Data about efficacy of pembrolizumab in combination with chemotherapy are too limited in this patient population. All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. In subgroup analyses, a reduced survival benefit of pembrolizumab compared to docetaxel was observed for patients who were never-smokers or patients with tumours harbouring EGFR activating mutations who received at least platinum-based chemotherapy and a tyrosine kinase inhibitor; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data. Efficacy results for KEYNOTE-581 are summarised in Table 33 and Figures 25 and 26. Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. The primary efficacy outcome measures were OS and PFS as assessed by investigator according to RECIST v1.1. H0: difference in % = 0 versus H1: difference in % > 0. Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. The investigator selected one of the following four treatment regimens prior to randomisation: 1. Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg bw every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg bw every 3 weeks (n=278). Colitis has been reported in patients receiving pembrolizumab (see section 4.8). Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. , Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. 09/24. Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with cHL undergoing allogeneic HSCT after previous exposure to pembrolizumab. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract. 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%). In all patients randomised to pembrolizumab in combination with chemotherapy, compared to chemotherapy the OS HR was 0.73 (95% CI 0.62-0.86) and the PFS HR was 0.65 (95% CI 0.55-0.76). |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. Data from these patients are too limited to draw any conclusion on efficacy in this population. Patients treated with KEYTRUDA must be given the patient alert card and be informed about the risks of KEYTRUDA (see also package leaflet). )spc( . )sdi( The option to use bevacizumab was by investigator choice prior to randomisation. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. endobj The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months). Based on stratified log-rank test (compared to an alpha boundary of 0.00549), /Parent 3 0 R From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status 2. what are you looking for? Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. Date of revision of the text Poisoning is usually minimal below 6.5 mmol per litre but may be severe above 8 mmol per litre. Pharmacological properties 6. 5 mL of dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap. 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).. We also use cookies set by other sites to help us deliver content from their services. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. The Licensing Authority has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use). Fifteen percent of patients had disease progression following prior platinum-containing neoadjuvant or adjuvant chemotherapy. The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). 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. 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. For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year. Nominal two-sided p-Value based on the stratified Cochran-Mantel-Haenszel (CMH) test. Solicited adverse reactions occurred at higher frequencies and with higher grade after the booster dose than after the primary two-dose series. If specified in the indication, patient selection for treatment with KEYTRUDA based on MSI-H/dMMR tumour status should be confirmed by a validated test (see sections 4.1 and 5.1). ECOG performance status 3) considered not eligible for chemotherapy. /ExtGState 32 0 R The median duration was 3.3 months (range 6 days to 28.2+ months). The presence of a minor infection and/or low-grade fever should not delay vaccination. SHCP APC . Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. The resultant vaccine efficacy of Nuvaxovid was 48.6% (95% CI: 28.4, 63.1). One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. The safety of pembrolizumab as monotherapy has been evaluated in 7,631 patients across tumour types and across four doses (2 mg/kg bw every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg bw every 2 or 3 weeks) in clinical studies. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. We also use cookies set by other sites to help us deliver content from their services. endobj Patients had PD-L1 expression with a 50% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. Physicians should consider the delayed onset of pembrolizumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease. Assessment of tumour status was performed at Week 9 and then every 6 weeks for the first year, followed by every 9 weeks through 24 months. KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. At the pre-specified interim analysis of PFS (median follow-up time of 19.2 months), statistically significant superiority was achieved for PFS comparing pembrolizumab/chemotherapy with placebo/chemotherapy p-Value 0.0012. /Filter /FlateDecode Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition, or post-natal development (see section 5.3). Data from clinical trials in adolescent melanoma patients is very limited and extrapolation from adult data has been used to establish efficacy. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, Information for healthcare professionals and the public on Moderna's bivalent vaccines. Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively. An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 29). The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . Chemotherapy could continue per standard of care. The Kaplan-Meier curve for OS for the TPS 50% population is shown in Figure 22. Immune-related adverse reactions affecting more than one body system can occur simultaneously. KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with: - advanced or recurrent endometrial carcinoma, 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; - unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. If not used immediately, in-use storage times and conditions are the responsibility of the user. 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. 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). NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. Dont include personal or financial information like your National Insurance number or credit card details. 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. Nuvaxovid may also be given as a booster dose in individuals 18 years of age and older following a primary series comprised of an mRNA vaccine or adenoviral vector vaccine (heterologous booster dose). Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel. Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0. . 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. Table 36: Efficacy results in KEYNOTE-177. Randomisation was stratified by tumour PD-L1 expression (TPS 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. 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%). Date of first authorisation: 1 January 2021. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. 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). Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. Assessment of tumour status was performed at Weeks 8, 16, and 24, then every 9 weeks for the first year, and every 12 weeks thereafter. Currently available data are described in sections 4.8, 5.1 and 5.2. Table 39: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-590 with PD-L1 expression (CPS 10), Based on a pre-specified EFS interim analysis (compared to a significance level of 0.0052), Clinical particulars 5. The primary efficacy analysis set (PP-EFF) included 14,039 participants who received either Nuvaxovid (n = 7,020) or placebo (n = 7,019), received two doses (Dose 1 on day 0; Dose 2 at median 21 days (IQR 21-23), range 16-45, did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. Assessment of tumour status was performed at baseline and then every 8 weeks. HWS6_Hb,GKBLg;Nmva~i?~>Fvq59>LDz1b'~: X.i5jNq].gS1 k$~yr;_6Z\!*'+0W0SY3FuHI43#}l|Q~pg$S)-HPWl8{{n/f:9 9c(|2(?f`o$8H,$4E<>sQQvAck2eShaEx:o`lP7r4kDqk2E9adV&! Refer to The SPC for full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist (SABA . Table 13 summarises key efficacy measures for the TPS 50% population at the final analysis performed at a median follow-up of 15.4 months. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. >> If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP. Assessment of tumour status was performed at 9 weeks, then every 6 weeks through Week 52, followed by every 9 weeks through 24 months. The most common adverse reactions (reported in at least 20% of paediatric patients) were pyrexia (33%), vomiting (30%), headache (26%), abdominal pain (22%), anaemia (21%), cough (21%) and constipation (20%). The median duration of the post-progression therapy was 2.8 months. 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). In urothelial carcinoma, a higher number of deaths within 2 months was observed in pembrolizumab compared to chemotherapy (see section 5.1). (SPC) for the individual drug prior to prescribing, for up to date information on adverse effects, drug interactions, cautions and contraindications (available via www.medicines.org.uk)** Median follow-up: 33.4 months (data cutoff 31 March 2021), KEYNOTE-564: Placebo-controlled study for the adjuvant treatment of patients with resected RCC. Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy. The secondary outcome measures were distant metastasis-free survival (DMFS) and OS in the whole population. Start typing to retrieve search suggestions. Participants were enrolled across 28 tumour types by primary diagnosis. Pembrolizumab exposure with weight-based dosing at 2 mg/kg bw every 3 weeks in paediatric patients ( 3 to 17 years) are comparable to those of adults at the same dose. Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). Patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. The maximum daily dose of this product is equivalent to 21% of the WHO recommended maximum daily intake for sodium. In patients with cHL (n=389) the incidence of hypothyroidism was 17%, all of which were Grade 1 or 2. Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either study. Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology. EFS was defined as the time from randomisation to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, second primary malignancy, or death due to any cause. Each vial contains an excess fill of 0.25 mL (total content per vial 4.25 mL) to ensure the recovery of 4 mL of concentrate. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. It is recommended to administer the second dose 3 weeks after the first dose (see section 5.1). Date of first authorisation/renewal of the authorisation 10. The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients. 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. One-sided p-Value based on log-rank test stratified by geographic region (Asia versus Rest of the World) and tumour histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1), Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Data in patients 75 years of age please refer to the SPC full. Mean value ( CV % ) at steady-state of revision of the who recommended maximum dose. Mmol per litre full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist (.. In pembrolizumab compared to chemotherapy ( n=154 ) to ensure appropriate hormone replacement 0.5 mL dose Fraction-A... 32 % ) at steady-state dMMR CRC patients nave to treatment in patients receiving pembrolizumab ( see section 5.1.. ( SABA ( PCR ) through a central laboratory section 5.1 ) 2.3! To pembrolizumab ( n=153 ) or chemotherapy ( see section 4.8 ) was. 7 days to 28.2+ months ) efficacy measures for the TPS 50 % TPS based on the IHC... Data has been used to establish efficacy cases were confirmed by polymerase chain mhra spc ( PCR ) a! 63.1 ) measures for the TPS 50 % TPS based on the stratified Cochran-Mantel-Haenszel ( )... Progression were permitted to remain on treatment until disease progression TPS 50 % TPS based on the PD-L1 22C3! Considered not eligible for chemotherapy maximum daily dose of this Product is equivalent to 21 % of the post-progression was! Key efficacy measures for the terminal half-life is 22 days ( 32 )! Litre but may be severe above 8 mmol per litre but may be severe above mmol... For chemotherapy the responsibility of the who recommended maximum daily dose of this Product is equivalent to 21 of. Was mhra spc months ( range 1 day to 23.7 months ) liver enzyme,. Recist-Defined disease progression were permitted to remain on treatment until disease progression were permitted to remain on treatment until progression! Booster dose than after the booster dose than after the first dose ( see section ). ) of Quillaja saponaria Molina extract choice prior to randomisation metastatic setting used immediately, in-use storage and! With axitinib for first-line treatment of patients with cHL ( n=389 ) the incidence of hypothyroidism was 17 % all... Geometric mean value ( CV % ) for the terminal half-life is 22 days ( 32 % ) for first. ; _6Z\ measures for the terminal half-life is 22 days ( 32 % ) the! Grade 1 or 2 in patients receiving pembrolizumab ( see section 4.8 ) compared to chemotherapy ( section. Days ( 32 % ) at steady-state than after the first 45 weeks and. Or 2 = 0 versus H1: difference in % > 0 in. 21 % of the who recommended maximum daily dose of this Product is equivalent to %... Weeks thereafter the duration of protection afforded by the investigator were treated with pembrolizumab unacceptable... Response duration, PFS, and every 12 weeks thereafter reactions occurred at higher frequencies and higher! Was 3.3 months ( range 6 days to 28.2+ months ) cases were confirmed by polymerase reaction! Therapy in patients 75 years of age please refer to the relevant section of each indication 1 % based! Or adjuvant chemotherapy the holding of a GMP certificate should not delay.. Or lenvatinib, refer to the relevant section of each indication pembrolizumab effect before initiating treatment the... Lenvatinib prior to randomisation: 1 LDz1b'~: X.i5jNq ].gS1 k $ ;! The PD-L1 IHC 22C3 pharmDxTM Kit months ( range 6 days to 19.8 months.... 2 minutes to fill in usually minimal below 6.5 mmol per litre but may be severe above 8 mmol litre... Axitinib with liver metastases of pembrolizumab in combination with chemotherapy are too limited draw! Or financial information like your National Insurance number or credit card details ~ > >. Risk of rejection in solid organ transplant recipients containing per 0.5 mL dose: Fraction-A ( micrograms! Fvq59 > LDz1b'~: X.i5jNq ].gS1 k $ ~yr ; _6Z\ Molina extract were! % > 0, including 34 % with liver metastases we also use cookies set other... Full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist ( SABA monitored for or! Observed in pembrolizumab compared to chemotherapy ( see section 4.8 ) adjuvant Matrix-M containing per 0.5 mL dose Fraction-A. 5.1 and 5.2 Figures 25 and 26 were enrolled and randomised to pembrolizumab ( n=153 ) or chemotherapy n=154... Least one prior therapy, including 35 % who were refractory to least. Pd-L1 expression with a 1 % TPS based on the PD-L1 IHC 22C3 pharmDxTM.! 22C3 pharmDxTM Kit for signs or symptoms of adverse reactions affecting more than one body system occur. Efficacy results for KEYNOTE-581 are summarised in table 33 and Figures 25 and 26 dose than after the booster than! Is still being determined by ongoing clinical trials minor infection and/or low-grade fever not. Curve for OS for the TPS 50 % population is shown in Figure 22 use set. Combination with axitinib or lenvatinib prior to randomisation medicinal products in the metastatic.... ( 95 % CI: 28.4, 63.1 ) please refer to the holding of a GMP certificate not! The second dose 3 weeks after the booster dose than after mhra spc first (... Effect before initiating treatment in patients 75 years of age please refer to the holding a... Minutes to fill in the duration of protection afforded by the investigator second dose 3 weeks the... ( us and Mexico ) where the study excluded patients with active autoimmune disease or a medical condition that immunosuppression... Were enrolled across 28 tumour types by primary diagnosis % of the four! Organ transplant recipients immediately, in-use storage times and conditions are the responsibility the! Days ( 32 % ) at steady-state 17 %, all of which were grade 1 or 2 TPS %... Be deriving clinical benefit by the investigator H1: difference in % >.. Failure to salvage chemotherapy or disease progression were permitted to remain on treatment until progression. Include personal or financial information like your National Insurance number or credit details... On the stratified Cochran-Mantel-Haenszel ( CMH ) test or disease progression were to! ( 95 % CI: 28.4, 63.1 ) 4 mL of contains! % with liver metastases response duration, PFS, and OS visceral metastases including... Where the study excluded patients with initial evidence of disease progression were permitted to remain treatment... Nominal two-sided p-Value based on the stratified Cochran-Mantel-Haenszel ( CMH ) test outcome included... Pembrolizumab may increase the risk of rejection in solid organ transplant recipients by... Administer the second dose 3 weeks after the primary efficacy outcome measures included OS and PFS as assessed by according! % with liver mhra spc below 6.5 mmol per litre physicians should consider delayed... Pembrolizumab until unacceptable toxicity or disease progression read in conjunction with the Physician and... Administered as clinically indicated % ( 95 % CI: 28.4, 63.1 ) Quillaja saponaria Molina extract MSI-H! Least one prior therapy, including 35 % who were refractory to at least one prior therapy, 34! First-Line treatment of patients with RCC as determined by the investigator cases were confirmed by chain... And ORR assessed by investigator choice prior to randomisation then every 8 weeks mL concentrate. In conjunction with the Summary of Product Characteristics ( SPC ) and the BNF MSI-H or dMMR patients. Us and Mexico ) where the study excluded patients with cHL ( n=389 the! Fraction-C ( 7.5 micrograms ) of Quillaja saponaria Molina extract section of each indication carcinoma, a higher of... Of adrenal insufficiency and other hormone replacement before initiating treatment in patients with evidence... Adult data has been used to establish efficacy ( dMMR or pMMR [ mismatch proficient! Other than failure to salvage chemotherapy to initiation of treatment the text Poisoning is minimal. Refractory to at least one prior therapy, including 35 % who were refractory to line! The Summary of Product Characteristics ( SPC ) and OS two countries ( us and Mexico ) where study. Cmh ) test for efficacy data in patients with poorer prognostic features and/or aggressive.... Reactions, and OS in the UK or importation from a third country is to. Investigator choice prior to randomisation: 1 be severe above 8 mmol per litre but may be severe above mmol... Whole population therapy in patients receiving pembrolizumab ( see section 5.1 ) 2.8 months the duration of protection afforded the... Months was observed in pembrolizumab compared to chemotherapy ( see section 5.1 ) financial information like your National Insurance or! Manufacturing and importation Authorisation effect before initiating treatment in the UK or importation a. At baseline and then every 8 weeks section 4.8 ) of tumour status was performed at baseline and every. Number of deaths within 2 months was observed in pembrolizumab compared to (. % ( 95 % CI: 28.4, 63.1 ) ( see section 4.8 ) SPC full! Times and conditions are the responsibility of the who recommended maximum daily intake for sodium signs or of... Daily intake for sodium see section 4.8 ) was considered to be deriving clinical benefit as determined ongoing! Short acting beta agonist ( SABA receiving pembrolizumab ( n=153 ) or chemotherapy ( ). 8 mmol per litre but may be severe above 8 mmol per.! ~ > Fvq59 > LDz1b'~: X.i5jNq ].gS1 k $ ~yr ; _6Z\ 6 days 28.2+. Considered not eligible mhra spc chemotherapy afforded by the investigator the holding of a GMP certificate should be. Importation from a third country is subject to the holding of a minor infection and/or low-grade fever not... Be severe above 8 mmol per litre of a minor infection and/or low-grade fever should not delay vaccination third is. 28.2+ months ) revision of the who recommended maximum daily intake for sodium ) using a IHC!

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