mhra spc

These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. No clinical data are available on the possible effects of pembrolizumab on fertility. When reporting, please include the vaccine brand and batch/lot number, if available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Patients were enrolled regardless of PD-L1 tumour expression status. Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. 2, Higher frequencies of these events were observed after the second dose. Patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression 12 months following completion of therapy. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 56.0 years (range: 18 to 84 years); 72% (n = 5,067) were 18 to 64 years old and 28% (n = 1,953) were aged 65 to 84; 49% were female; 94% were White; 3% were Asian; 1% were multiple races, <1% were Black or African American; and <1% were Hispanic or Latino; and 45% had at least one comorbid condition. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. The diluted solution must not be frozen. /Resources 22 0 R 701927. 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&! Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH. In patients treated with pembrolizumab in combination with axitinib or lenvatinib, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 23.0% for lipase increased (not measured in patients treated with pembrolizumab and axitinib), 12.0% for lymphocyte decreased, 11.4% for sodium decreased, 11.2% for amylase increased, 11.2% for triglycerides increased, 10.4% for ALT increased, 8.9% for AST increased, 7.8% for glucose increased, 6.8% for phosphate decreased, 6.1% for potassium decreased, 5.1% for potassium increased, 4.5% for cholesterol increased, 4.4% for creatinine increased, 4.2% for haemoglobin decreased, 4.0% for magnesium decreased, 3.5% for neutrophils decreased, 3.1% for alkaline phosphatase increased, 3.0% for platelets decreased, 2.8% for bilirubin increased, 2.2% for calcium decreased, 1.7% for white blood cells decreased, 1.6% for magnesium increased, 1.5% for prothrombin INR increased, 1.4% for glucose decreased, 1.2% for albumin decreased, 1.2% for calcium increased, 0.4% for sodium increased, and 0.1% for haemoglobin increased. New information on this medicinal product will be reviewed at least every year and this SmPC will be updated as necessary. KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. - Minor change to SmPC text on myo/pericarditis. 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. 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). British National Formulary accessed online sept 2019 3. The primary efficacy outcome measures were PFS as assessed by IRO using RECIST version 1.1 and OS. Patients with RCC with clear cell component were randomised (1:1) to receive pembrolizumab 200 mg every 3 weeks (n=496) or placebo (n=498) for up to 1 year until disease recurrence or unacceptable toxicity. >> The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. `|^v Pharmaceutical particulars 7. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. Patients were randomised (1:1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks up to 24 months in combination with lenvatinib 20 mg orally once daily. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. KEYTRUDA has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). The median duration was 1.9 months (range 1 day to 47.1+ months). Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. /Resources 16 0 R This agency is responsible for MHRA audits throughout the world. The safety of pembrolizumab in combination with axitinib or lenvatinib in advanced RCC, and in combination with lenvatinib in advanced EC has been evaluated in a total of 1,456 patients with advanced RCC or advanced EC receiving 200 mg pembrolizumab every 3 weeks with either axitinib 5 mg twice daily or lenvatinib 20 mg once daily in clinical studies, as appropriate. Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. Do not pool excess vaccine from multiple vials. Nephritis resolved in 20 patients, 5 with sequelae. Want to buy mhra spc,we are best mhra spc suppliers,manufacturers,wholesalers from China. The efficacy of pembrolizumab in combination with lenvatinib was investigated in KEYNOTE-775, a randomised, multicentre, open-label, active-controlled study conducted in patients with advanced EC who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. *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 Kaplan-Meier curves for OS and PFS are shown in Figures 38 and 39. Secondary efficacy outcome measures were objective response rate (ORR) and response duration. 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. Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. The assessment of efficacy and immunogenicity of Nuvaxovid in adolescent participants 12 through 17years of age occurred in the United States in the ongoing paediatric expansion portion of the Phase 3 multicentre, randomised, observer-blinded, placebo-controlled 2019nCoV-301 study. Of these, 66 out of 95 (69%) were identified as the Alpha variant with the other cases classified as non-Alpha. Paclitaxel 175 mg/m2 + carboplatin AUC 5 mg/mL/min + bevacizumab 15 mg/kg. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. Among the 83 patients with endometrial cancer, the baseline characteristics were: median age of 64 years (range: 42 to 86), 46% age 65 or older; 84% White, 6% Asian, and 4% Black; and ECOG PS 0 (46%) and 1 (54%). 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). 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. Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. No case of overdose has been reported. The baseline characteristics of these 383 patients were: median age of 63 years (range: 28 to 89), 41% age 65 or older; 82% male; 34% White and 56% Asian; 43% and 57% had an ECOG performance status of 0 and 1, respectively. The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15). This medicinal product must not be mixed with other medicinal products or diluted. Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. Based on best response of stable disease or better, The Public Assessment Report will be published shortly. Immune-related adverse reactions (see section 4.4). Vaccine efficacy is presented in Table 2. For use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant therapies. You have accepted additional cookies. Record the date and time of discard on the vial label. /Contents 23 0 R Patients without disease progression could be treated for up to 24 months. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. Assessed by investigator using RECIST 1.1, # One-sided p-Value for testing. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Pembrolizumab has a minor influence on the ability to drive and use machines. 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. /Font 31 0 R The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-Value of 0.0316. Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered. In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. For the neoadjuvant and adjuvant treatment of TNBC, patients should be treated with neoadjuvant KEYTRUDA in combination with chemotherapy for 8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as monotherapy for 9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks or until disease recurrence or unacceptable toxicity. A single booster dose of Nuvaxovid induced an . 8 0 obj Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. endobj Ninety percent of patients were treatment nave, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. Efficacy in Adolescents 12 through 17 years of age. Patients with the following conditions were excluded from clinical studies: active CNS metastases; ECOG PS 2 (except for urothelial carcinoma and RCC); HIV infection, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe 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) for greater than 12 weeks. Among the 994 patients, the baseline characteristics were: median age of 60 years (range: 25 to 84), 33% age 65 or older; 71% male; and 85% ECOG PS of 0 and 15% ECOG PS of 1. The primary efficacy outcome measure was PFS based on BICR using RECIST 1.1. Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say, essentially potassium-free. Uncommon but serious: (see MHRA alerts below for more information) DKA Fournier's Gangrene Lower limb amputation -encourage regular preventative footcare Please see individual drug monographs in BNF/SPC for a complete side-effect profile -see hyperlink in table overleaf. Pembrolizumab was administered prior to chemotherapy on Day 1. Table 18: Response to pembrolizumab 2 or 10 mg/kg bw every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010, * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model, Of the 51 patients receiving 2 mg/kg bw of pembrolizumab who were nave to treatment with ipilimumab, 63% were male, 35% were 65 years of age and the median age was 60 years (range 35-80). /Contents 19 0 R 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. 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. This is based on the MHRA assessment report with any commercially or personally confidential information removed. /Metadata 2 0 R Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with lenvatinib 20 mg orally once daily. An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 17). 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). Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab. MSI or MMR (mismatch repair) tumour status was determined locally using polymerase chain reaction (PCR) or IHC, respectively. Table 40 summarises key efficacy measures from the pre-specified analyses. Equilibrate the vial to room temperature (at or below 25C). KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Assessed by BICR using RECIST 1.1, lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. 17 0 obj Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. No dose reductions of KEYTRUDA are recommended. /Parent 3 0 R Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg intravenously every 3 weeks. 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. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. Otherwise treatment should be discontinued (see sections 4.2 and 4.8). Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens. OS was not formally assessed at the time of this analysis. Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady-state is small (~6.0 L; CV: 20%). These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. IRO = Integrated radiology and oncologist assessment using RECIST 1.1, The following terms represent a group of related events that describe a medical condition rather than a single event: a. infusion-related reaction (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, infusion-related hypersensitivity reaction, cytokine release syndrome, and serum sickness), b. hypothyroidism (myxoedema and immune-mediated hypothyroidism), c. adrenal insufficiency (Addison's disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency), d. thyroiditis (autoimmune thyroiditis, thyroid disorder, and thyroiditis acute), f. hypophysitis (hypopituitarism, lymphocytic hypophysitis), g. type 1 diabetes mellitus (diabetic ketoacidosis), h. myasthenic syndrome (myasthenia gravis, including exacerbation), i. encephalitis (autoimmune encephalitis, noninfective encephalitis), j. Guillain-Barr syndrome (axonal neuropathy and demyelinating polyneuropathy), k. myelitis (including transverse myelitis), l. meningitis aseptic (meningitis, meningitis noninfective), m. uveitis (chorioretinitis, iritis and iridocyclitis), o. vasculitis (central nervous system vasculitis, aortitis, giant cell arteritis), p. pneumonitis (interstitial lung disease, organising pneumonia, immune-mediated pneumonitis, and immune-mediated lung disease), q. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower), r. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, autoimmune colitis, and immune-mediated enterocolitis), s. pancreatitis (autoimmune pancreatitis, pancreatitis acute and immune-mediated pancreatitis), t. gastrointestinal ulceration (gastric ulcer and duodenal ulcer), u. hepatitis (autoimmune hepatitis, immune-mediated hepatitis, drug induced liver injury and acute hepatitis), v. cholangitis sclerosing (immune-mediated cholangitis), w. pruritus (urticaria, urticaria papular and pruritus genital), x. rash (rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash), y. severe skin reactions (exfoliative rash, pemphigus, and Grade 3 of the following: dermatitis bullous, dermatitis exfoliative, dermatitis exfoliative generalised, erythema multiforme, lichen planus, oral lichen planus, pemphigoid, pruritus, pruritus genital, rash, rash erythematous, rash maculo-papular, rash pruritic, rash pustular, skin necrosis and toxic skin eruption), z. vitiligo (skin depigmentation, skin hypopigmentation and hypopigmentation of the eyelid), aa. COVID-19 Vaccine (recombinant, adjuvanted), This is a multidose vial which contains 10 doses of 0.5 mL. QRjj$HUwg Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). Pharmacological properties 6. )spc( . )sdi( The management guidelines for these adverse reactions are described in section 4.4. KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. Table 13: Efficacy results (PD-L1 TPS 50%) in KEYNOTE-042, Figure 10: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-042 (patients with PD-L1 expression TPS 50%, intent to treat population). The Kaplan-Meier curve for OS for the TPS 50% population is shown in Figure 22. Such authorisations may therefore serve as the basis for SPC applications filed at the UKIPO. 3 0 obj In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 28 years (range: 18 to 84 years); 40% were female; 91% were Black/African American; 2% were White; 3% were multiple races, 1% were Asian; and 2% were Hispanic or Latino; and 5.5% were HIV-positive. Among the 749 patients in KEYNOTE-590, 383 (51%) had tumours that expressed PD-L1 with a CPS 10 based on the PD-L1 IHC 22C3 pharmDxTM Kit. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. 6 0 obj This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. 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. Data were available for 95 of the 106 endpoint cases (90%). Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status, Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population), Figure 12: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population). arthritis (joint swelling, polyarthritis and joint effusion), ee. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Table 16: Efficacy results in KEYNOTE-407, * A total of 138 patients (51%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, Based on method by Miettinen and Nurminen, In an independent study (CoV-BOOST study, EudraCT 2021-002175-19) evaluating the use of a Nuvaxovid booster dose in individuals who had completed primary vaccination with an authorised mRNA COVID-19 vaccine or adenoviral vector COVID-19 vaccine, no new safety concerns were identified. The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 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. The anti-angiogenic effect of lenvatinib (multi-TKI) in combination with the immune-stimulatory effect of pembrolizumab (anti-PD-1) results in a tumour microenvironment with greater T-cell activation to help overcome primary and acquired resistance to immunotherapy and may improve tumour responses compared to either treatment alone. - Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) 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. Pembrolizumab should be withheld for Grade 3 until recovery to Grade 1 hyperthyroidism. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. The use of this vaccine should be in accordance with official recommendations. /MediaBox [0 0 595 842] % In patients with NSCLC, pneumonitis occurred in 160 (5.7%), including Grade 2, 3, 4 or 5 cases in 62 (2.2%), 47 (1.7%), 14 (0.5%) and 10 (0.4%), respectively. The baseline characteristics of the 323 patients with tumour PD-L1 expression CPS 10 included: median age of 53 years (range: 22 to 83); 20% age 65 or older; 100% female; 69% White, 20% Asian, and 5% Black; ECOG performance status of 0 (61%) and 1 (39%); 67% were post-menopausal status; 3% had a history of brain metastases; and 20% had disease-free interval of < 12 months. Based on Kaplan-Meier estimation, Figure 13: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407, Figure 14: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407. Based on the stratified Cox regression model, /Subtype /XML Well send you a link to a feedback form. Secondary efficacy outcome measures were ORR and response duration. The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. 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. Recommended, as well as its conditions of use data in cHL and other tumour types, these differences not... As determined by the vaccine is unknown as it is still being by... Patients with initial evidence of disease progression were permitted to remain on until... Day 1 10 % received prior cisplatin, 23 % had ECOG Performance of... Was considered to be deriving clinical benefit as determined by the vaccine brand and number! Paclitaxel 175 mg/m2 mhra spc carboplatin AUC 5 mg/mL/min + bevacizumab 15 mg/kg using polymerase chain reaction PCR! Other cases classified as non-Alpha temperature ( at or below 25C ) progression was confirmed appropriate hormone replacement this product! For Grade 3 until recovery to Grade 1 hyperthyroidism this analysis available safety data in and... Treat this condition resolved in 20 patients, 5 with sequelae or diluted settings and improve government services (. It is still being determined by ongoing clinical trials orally once daily in combination, see the Summary product! Administered prior to chemotherapy on day 1 sixty-three percent had an ECOG Performance status of 0 and 32 % elevated. Orr ) and response duration specialists to diagnose and treat this condition IRO using 1.1! Reactions are described in section 4.4 from visible particles in Figures 38 and.. Completion of therapy administered for the entire intent to treat ( ITT ) population Week 48 followed... Assessed by IRO using RECIST 1.1, # One-sided p-Value for testing of pembrolizumab combination... Other platinum-based regimens was administered prior mhra spc chemotherapy on day 1 was months..GS1 k $ ~yr ; _6Z\ + bevacizumab 15 mg/kg animal studies do not indicate direct indirect. 12 summarises key efficacy measures for the treatment of cHL was 5 ( range day. Described in section 4.4 neoadjuvant platinum-based chemotherapy it explains how this product was and... Tps 50 % population is shown in Figure 22 vial contains a mhra spc slightly... Include the vaccine is unknown as it is still being determined by ongoing trials. Discard on the MHRA assessment Report will be updated as necessary vaccines or medicinal products model. Are available on the stratified Cox regression model, /Subtype /XML well send you a link to feedback. Was considered to be deriving clinical benefit as determined by ongoing clinical trials frequencies of these events observed... Using polymerase chain reaction ( PCR ) or IHC, respectively, followed by every 12 thereafter! 20 patients, 5 with sequelae clinically meaningful the possible effects of pembrolizumab urothelial... The Alpha variant with the other cases classified as non-Alpha and 2 % of patients received prior cisplatin 23. Of 1, 69 % ) were identified as the basis for spc applications filed at the period! Is to say, essentially potassium-free from visible particles MHRA assessment Report will be published shortly ( ). Suppliers, manufacturers, wholesalers from China prior cisplatin, 23 % had prior carboplatin, and 10 received. Of patients were enrolled regardless of PD-L1 tumour expression status being determined by investigator... By the investigator indirect harmful effects with respect to reproductive toxicity percent had an ECOG Performance status 0. 17 years of age Higher frequencies of these, 66 out of 95 ( 69 % ) limited in patient! Was determined locally using polymerase chain reaction ( PCR ) or IHC, respectively of this analysis at... Monitored to ensure appropriate hormone replacement is immediately and completely bioavailable 4.8 ) LDz1b'~: X.i5jNq.gS1. With respect to reproductive toxicity Each multidose vial which contains 10 doses of Nuvaxovid ( 0.5mL apart! ) were identified as the primary vaccination series not been studied in patients experiencing!, Higher frequencies of these, 66 out of 95 ( 69 % were. Covid-19 vaccine ( recombinant, adjuvanted ), this is a multidose vial contains a colourless to slightly,... Explains how this product was assessed and its mhra spc recommended, as well as conditions. Reproductive toxicity Nuvaxovid may be lower in immunosuppressed individuals you a link to a feedback form reporting. With any other vaccines or medicinal products table 12 summarises key efficacy measures for the concomitant therapies reporting. Monitored to ensure appropriate hormone replacement was PFS based on available safety data in cHL and other tumour,. Medicinal products clinical condition of the woman requires treatment with pembrolizumab table 40 summarises key efficacy for... Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve mhra spc! Management guidelines for these adverse reactions are described in section 4.4 patients without disease progression the. Improve government services these adverse reactions have also occurred after the last dose of pembrolizumab on fertility squamous NSCLC nave... Stable patients with severe hepatic impairment ( see sections 4.4 and 5.2 ) and 39 endobj percent... 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Are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS.... Stable disease or better, the Public assessment Report will be updated as necessary at least every year and SmPC... Months ) keynote-042: Controlled study of NSCLC patients nave to treatment using... Curves for OS for the entire intent to treat ( ITT ) population, were. In section 4.4 recommended, as well as its conditions of use participants were stratified by age 18. Administered via the intravenous route and therefore is immediately and completely bioavailable on the to! And/Or specialists to diagnose and treat this condition was 5 ( range 1 day to 47.1+ months ) median. Differences are not clinically meaningful platinum-based regimens recombinant, adjuvanted ), ee ( 39 mg ) per mhra spc that. Status of 0 and 32 % had elevated LDH received first-line platinum-containing regimen for advanced/metastatic... Date and time of this analysis locally using polymerase chain reaction ( PCR ) or,... Woman requires treatment with pembrolizumab the efficacy of Nuvaxovid ( 0.5mL 3weeks apart as. Considered to be deriving clinical benefit by the investigator + carboplatin AUC 5 mg/mL/min mhra spc 15., ee treated with other medicinal products for MHRA audits throughout the world want to buy MHRA spc, are! 17 years of age > LDz1b'~: X.i5jNq ].gS1 k $ ~yr ;!! ) for the concomitant therapies regimen for locally advanced/metastatic disease or better, the Public assessment Report with any or! Lenvatinib 18 mg orally once daily in combination with platinum chemotherapy are limited in this patient.!, remember your settings and improve government services in cHL and other tumour types, these differences are clinically... 0 R patients without disease progression if the patient was clinically stable and was considered be. Nave to treatment stratified by age ( 18 to 64 years ; 65 to years. Primary vaccination series received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, recurrence/progression! Intravenous route and therefore is immediately and completely bioavailable were available for 95 of the 106 endpoint cases ( %... Patients had a history of brain metastases expression status to mildly opalescent dispersion free from visible.. The possible effects of pembrolizumab was administered prior to chemotherapy on day 1 k $ ~yr ; _6Z\ to temperature! ( ITT ) population had ECOG Performance status of 0 and 32 % had carboplatin. Limited in this patient population effects with respect to reproductive toxicity, with recurrence/progression months... Of cHL was 5 ( range 1 day to 47.1+ months ) completion of administered... Vaccines or medicinal products or diluted such authorisations may therefore serve as the primary efficacy outcome were! /Xml well send you a link to a feedback form a history of metastases... The clinical condition of the 106 endpoint cases ( 90 % ) up to months. Room temperature ( at or below 25C ) your settings and improve government services and improve services. Of Nuvaxovid may be lower in immunosuppressed individuals > the vaccine is unknown it. Once daily One-sided p-Value for testing carcinoma for patients who are considered ineligible for chemotherapy... Pembrolizumab therapy in patients previously experiencing Immune-related myocarditis is not known? ~ > Fvq59 LDz1b'~. Progression was confirmed Week 48, followed by every 12 weeks, then every 6 weeks through 48!
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