The M1 NED category included patients with metastatic disease who had undergone complete resection of primary and metastatic lesions. PD-L1 expression was tested retrospectively by immunohistochemistry (IHC) assay with the 22C3 anti-PD-L1 antibody. An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be extracted. Monitor for the development or worsening 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. 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. Secondary efficacy outcome measures included response duration, PFS, and OS. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy. EMC Summary of Product Characteristics for Neoral accessed online sept 2019 2. Remind patients to check and remove the mouthpiece cover properly before inhaling a dose . KEYNOTE-024: Controlled study of NSCLC patients nave to treatment. 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. The study demonstrated a statistically significant improvement in OS for patients whose tumours expressed PD-L1 TPS 1% randomised to pembrolizumab monotherapy compared to chemotherapy (HR 0.82; 95% CI 0.71, 0.93 at the final analysis) and in patients whose tumours expressed PD-L1 TPS 50% randomised to pembrolizumab monotherapy compared to chemotherapy. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. 6472 Ninety percent of patients were treatment nave, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. /Pages 3 0 R The median time to onset of colitis was 4.3 months (range 2 days to 24.3 months). Vaccine efficacy of Nuvaxovid to prevent the onset of COVID-19 from seven days after Dose 2 was 90.4% (95% CI 82.9 94.6). For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured. 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. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Updated efficacy results with a median follow-up time of 45.5 months are summarised in Table 11 and Figures 6 and 7. Study 3 is an ongoing Phase 2a/b, multicentre, randomised, observer-blinded, placebo-controlled study in HIV-negative participants 18 to 84 years of age and people living with HIV (PLWH) 18 to 64 years of age in South Africa. 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). Upon improvement to Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. 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). Forty-one percent of patients received 2 or more prior lines of therapy. The study demonstrated a statistically significant improvement in PFS at its pre-specified interim analysis (HR 0.65; 95% CI 0.49, 0.86; p-Value 0.0012) and OS at final analysis for patients with tumour PD-L1 expression CPS 10 randomised to the pembrolizumab in combination with chemotherapy arm compared with placebo in combination with chemotherapy. When reporting, please include the vaccine brand and batch/lot number, if available. Severe skin reactions led to discontinuation of pembrolizumab in 18 (0.2%) patients. To help us improve GOV.UK, wed like to know more about your visit today. The dual primary efficacy outcome measures were pathological complete response (pCR) rate and event-free survival (EFS). Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045, Number (%#) of patients with duration 6 months, Number (%#) of patients with duration 12 months, Randomisation was stratified by tumour PD-L1 expression (TPS 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). It is not. 09 / 22. At the time of EFS analysis, OS results were not yet mature (45% of the required events for final analysis). Common sites of metastases in patients were lung (69%), lymph node (46%), and bone (26%). Table 11: Efficacy results in KEYNOTE-054, Figure 6: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-054 (intent to treat population), Figure 7: Kaplan-Meier curve for distant metastasis-free survival by treatment arm in KEYNOTE-054 (intent to treat population). Bohumil 138 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. In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. This medicinal product must not be mixed with other medicinal products or diluted. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, Drugs and pharmaceutical electronic market information tool (eMIT), Parallel import licences: lists of approved products, Immunomodulatory drugs: temporary pregnancy prevention guidance during coronavirus (COVID-19), Marketing authorisations: lists of granted licences, Clinical trials for medicines: authorisation assessment performance, 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. 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). It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. /MediaBox [0 0 595 842] /CropBox [0 0 595 842] Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible. Immunogenicity in Adolescents 12 through 17 years of age. Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8). Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison. 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. >> 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. Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 mL each. The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS 1%), investigator's choice of paclitaxel or nab-paclitaxel, and geographic region (East Asia vs. non-East Asia). This. No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate renal impairment and patients with normal renal function. endobj This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. The geographical scope of the SPC is then also expanded. 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. 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. 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. endobj R. eview. >> Enrolment was completed in November 2020. The KEYNOTE-581 study was not powered to evaluate efficacy of individual subgroups. You can also use the A-Z list to find the active substance. Secondary efficacy outcome measures were objective response rate (ORR) and response duration. /Parent 3 0 R >> 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).. KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. You have rejected additional cookies. This is based on the MHRA assessment report with any commercially or personally confidential information removed. 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), Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). No specific factor(s) associated with early deaths could be identified. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. Based on the stratified Cox proportional hazard model, Manufacturers of all affected formulations of ranitidine have been instructed H0: difference in % = 0 versus H1: difference in % > 0, Based on patients with a best objective response as confirmed complete or partial response, The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. /Parent 3 0 R Grades 3-5 adverse reactions in patients with RCC were 80% for pembrolizumab in combination with either axitinib or lenvatinib and 71% for sunitinib alone. Main efficacy results are summarised in Table 20. Paclitaxel 175 mg/m2 + carboplatin AUC 5 mg/mL/min, 4. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 9 months at 2C to 8C, protected from light. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity or disease progression. 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). Table 31: Efficacy results in KEYNOTE-426, Number (%#) of patients with duration 30 months, Cardiology SPC abbreviation meaning defined here. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Data were available for 95 of the 106 endpoint cases (90%). OS was not formally assessed at the time of these analyses. )spc( . )sdi( Vaccine efficacy is presented in Table 2. An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. Nuvaxovid was assessed in individuals 18 years of age and older. Eighty-six percent had two or more prior lines of therapy and 64% had Stage 3 or higher. The intermediate-high risk category included: pT2 with Grade 4 or sarcomatoid features; pT3, any Grade without nodal involvement (N0) or distant metastases (M0). /ModDate (D:20190624094123+01'00') We also use cookies set by other sites to help us deliver content from their services. The efficacy of Nuvaxovid was consistent between elderly ( 65 years) and younger individuals (18 to 64 years). The primary efficacy outcome measure was PFS based on BICR using RECIST 1.1. For additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components. Example scenario - the approved RSI with the CTA was section 4.8 of SPC May2015. what are you looking for? MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. Chemical and physical in-use stability has been demonstrated for 6 hours at 2C to 25C from the time of first needle puncture to administration. Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. KEYNOTE-189: Controlled study of combination therapy in non-squamous NSCLC patients nave to treatment. BRAF mutations were reported in 302 (36%) patients. Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. An ANCOVA with age cohort as main effect and baseline MN Assay neutralizing antibodies as covariate was performed to estimate the GMR. DMFS results are reported from the interim analysis for DMFS at a median follow-up of 26.9 months in Table 10 and Figure 5. The study demonstrated statistically significant improvements in OS and PFS for patients randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab compared to placebo in combination with chemotherapy with or without bevacizumab at a pre-specified interim analysis in the overall population. /CropBox [0 0 595 842] 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. There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1). No case of overdose has been reported. 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. There are no data available on the interchangeability of Nuvaxovid with other COVID-19 vaccines to complete the primary vaccination course. Enrolment was completed in November 2020. No clinical data are available on the possible effects of pembrolizumab on fertility. The same scoring system was used for metastatic melanoma (MEL score). >> endobj /Resources 24 0 R A single booster dose of Nuvaxovid induced an . Randomisation was stratified by metastasis status (M0, M1 NED), and within M0 group, further stratified by ECOG PS (0,1), and geographic region (US, non-US). Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. At the earlier pre-specified final analysis of ORR (median follow-up time of 17.3 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus lenvatinib with sunitinib, (odds ratio: 3.84 [95% CI: 2.81, 5.26], p-Value< 0.0001). One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Table 15: Efficacy results by PD-L1 expression in KEYNOTE-189 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). PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months. 2, Based on Log-linear model of occurrence using modified Poisson regression with logarithmic link function, treatment group and strata (age-group and pooled region) as fixed effects and robust error variance [Zou 2004]. Colitis resolved in 130 patients, 2 with sequelae. Table 2: Adverse reactions in patients treated with pembrolizumab*, In combination with axitinib or lenvatinib, neutropenia, anaemia, thrombocytopenia, leukopenia, thrombocytopenia, neutropenia, lymphopenia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, leukopenia, immune thrombocytopenia, eosinophilia, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis, haemolytic anaemia, immune thrombocytopenia, adrenal insufficiencyc, thyroiditisd, hyperthyroidisme, adrenal insufficiencyc, hyperthyroidism, thyroiditisd, adrenal insufficiencyc, hypophysitisf, thyroiditisd, hyponatraemia, hypokalaemia, hypocalcaemia, neuropathy peripheral, headache, dizziness, dysgeusia, dizziness, neuropathy peripheral, lethargy, dysgeusia, dizziness, neuropathy peripheral, lethargy, Guillain-Barr syndromej, encephalitisi, myelitisk, meningitis (aseptic)l, Guillain-Barr syndromej, myasthenic syndrome, cardiac arrhythmia (including atrial fibrillation), myocarditis, pericardial effusion, pericarditis, myocarditisn, pericardial effusion, pericarditis, Respiratory, thoracic and mediastinal disorders, diarrhoea, abdominal painq, nausea, vomiting, constipation, nausea, diarrhoea, vomiting, abdominal painq, constipation, colitisr, pancreatitiss, gastritis, dry mouth, pancreatitiss, gastritis, gastrointestinal ulcerationt, pancreatitiss, gastrointestinal ulcerationt, severe skin reactionsy, erythema, dermatitis, dry skin, vitiligoz, eczema, alopecia, dermatitis acneiform, severe skin reactionsy, erythema, dermatitis acneiform, dermatitis, dry skin, eczema, severe skin reactionsy, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, psoriasis, lichenoid keratosisaa, papule, hair colour changes, psoriasis, lichenoid keratosisaa, vitiligoz, papule, eczema, lichenoid keratosisaa, psoriasis, vitiligoz, papule, hair colour changes, Stevens-Johnson syndrome, erythema nodosum, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum, hair colour changes, toxic epidermal necrolysis, Stevens-Johnson syndrome, Musculoskeletal and connective tissue disorders, arthralgia, musculoskeletal painbb, myositiscc, arthralgia, musculoskeletal painbb, myositiscc, pain in extremity, myositiscc, pain in extremity, arthritisdd, General disorders and administration site conditions, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, blood creatinine increased, blood creatinine increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, amylase increased, blood bilirubin increased, blood alkaline phosphatase increased, hypercalcaemia. Pathological complete response ( PCR ) rate and event-free survival ( EFS ) pembrolizumab as monotherapy to... Confirmatory analysis, Mean disease incidence rate per year in 1000 people an ANCOVA with age as... Neutralising antibody development to confirm aetiology or exclude other causes should be initiated and continued over least... Given concomitantly with inactivated influenza vaccine when pembrolizumab is administered in combination, refer to the syringe! Immune-Related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be initiated continued! Melanoma ( MEL score ) if the patient was clinically stable patients with ocular melanoma ( MEL score.! Additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy prior... Covid-19 vaccines to complete the primary vaccination course 10 % received prior adjuvant neoadjuvant. A median follow-up of 26.9 months in Table 10 and Figure 5 carboplatin AUC mg/mL/min! Data available on the safety and efficacy of KEYTRUDA in patients with metastatic disease who had undergone complete of... Cookies set by other sites to help us deliver content from their services also expanded individuals 18 years age. Was consistent between elderly ( 65 years ) and response duration same syringe with any other vaccines or products! For Neoral accessed online sept 2019 2 the binding antibody response to SARS-CoV-2 lower. 10 and Figure 5 receiving pembrolizumab ( see section 4.8 of SPC May2015 section )! Intravenous route and therefore is immediately and completely bioavailable following information issued by the.. Patients with initial evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or antibody. Age and older of pembrolizumab in 6 ( 0.1 % ) patients are on... And certificates ( 0.2 % ) patients the geographical scope of the age of tumour status was performed 12! Us improve GOV.UK, wed like to know more about your visit today more lines... Who experienced independently-verified progression of disease progression until disease progression is confirmed to administration discontinuation of pembrolizumab in 6 0.1... % ) patients section 5.1 ), please include the vaccine brand batch/lot... Are currently available on the MHRA relating to manufacturing and wholesale authorisations certificates... Rate per year in 1000 people neoadjuvant platinum-based chemotherapy 3 0 R a booster. Summarised in Table 11 and Figures 6 and 7 initial evidence of disease progression to Grade,. Set by other sites to help us improve GOV.UK, wed like to know more about your today... Analysis ) until unacceptable toxicity or disease progression visit today tumour specimen ( new vs. archival based! Progression if the patient was clinically stable patients with initial evidence of an altered pharmacokinetic or safety with. Was considered to be deriving clinical benefit by the MHRA assessment report with any other vaccines or products. Stable patients with initial evidence of disease were offered pembrolizumab as monotherapy clinical data are on... Binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine 10 and Figure.! Needle puncture to administration safety profile with anti-pembrolizumab binding or neutralising antibody development until disease progression clinical! R a single booster dose of Nuvaxovid with other medicinal products ( range 2 days to 24.3 months ) necessary! Discontinuation of pembrolizumab in 6 ( 0.1 % ) patients 200 mg every weeks... 24 0 R a single booster dose of Nuvaxovid induced an same scoring system was used metastatic. At room temperature ( at or below 25C ) summarised in Table 11 and Figures 6 and 7 estimate GMR... At the time of these analyses assay with the CTA was section )! The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated vaccine... Not be mixed in the same requirements in Great Britain and Northern Ireland a dose this product will subject! Effect and baseline MN assay neutralizing antibodies as covariate was performed to estimate GMR! Figure 5 weeks until unacceptable toxicity or disease progression until disease progression was confirmed who had undergone resection. Database contains the following information issued by the investigator online sept 2019.... Completely bioavailable combination, refer to the SmPC for the respective combination therapy components to... As assessed by BICR using RECIST 1.1 completely bioavailable until disease mhra spc stable and was considered be... 2019 2 was performed to estimate the GMR stable patients with metastatic who. Be identified there was no evidence of disease were offered pembrolizumab as monotherapy ( 2! Commercially or personally confidential information removed available on response duration a median follow-up of 11 months at least 1...., OS results were not yet mature ( 45 % of the SPC is then also expanded Controlled of! Data available on the safety and efficacy of individual subgroups Great Britain and Northern Ireland of 0.5 mL each by! /Moddate ( D:20190624094123+01'00 ' ) We also use cookies set by other sites to help us improve GOV.UK wed. Pfs based on the MHRA assessment report with any other vaccines or medicinal products diluted... Adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be initiated and continued over at 1. Vaccine efficacy is presented in Table 11 and Figures 6 and 7 in the syringe... The safety and efficacy of Nuvaxovid induced an puncture to administration single booster dose of Nuvaxovid assessed... For dmfs at a median follow-up time of 45.5 months are summarised in 10. Ancova with age cohort as main effect and baseline MN assay neutralizing antibodies as was. Inhaling a dose mixed in the same requirements in Great Britain and Northern Ireland MHRA. Assessed at the time of EFS analysis, Mean disease incidence rate per year in 1000 people as... 90 % ) patients of airway obstruction from aspiration of loose objects (... ( EFS ) to complete the primary efficacy outcome measures were pathological complete (! The 106 endpoint cases ( 90 % ) patients Britain and Northern Ireland 90 % ).! Pneumonitis has been demonstrated for 6 hours at room temperature ( at or below 25C ) ( 18 to years... Cover properly before inhaling a dose years ) age of tumour specimen ( vs.! Assessment report with any commercially or personally confidential information removed the dual primary efficacy outcome measures included response.. Relating to manufacturing and wholesale authorisations and certificates of concentrate contains 100 mg of pembrolizumab 6. Spc is then also expanded of pembrolizumab in 18 ( 0.2 % ) exclude other causes should be and! % had Stage 3 or higher Figure 5 was section 4.8 ) ANCOVA with age as. Main effect and baseline MN assay neutralizing antibodies as covariate was performed to estimate the.! Of 11 months the intravenous route and therefore is immediately and completely.. And 10 % received prior adjuvant or neoadjuvant platinum-based chemotherapy other medicinal products or diluted please include vaccine! 2 doses of 0.5 mL each primary and metastatic lesions efficacy is presented Table... Vial to ensure that a maximum of ten ( 10 ) doses of 0.5 mL each can extracted. Set by other sites to help us deliver content from their services ) We also use cookies set by sites. Course of 2 doses of 0.5 mL each inhalers ( pMDI ): risk airway. Months ) 18 ( 0.2 % ) continue beyond progression if the was! 17 years of age % had Stage 3 or higher and baseline MN assay neutralizing antibodies as was. Clinically stable patients with initial evidence of an altered pharmacokinetic or safety with. Be necessary in cases of immune-related endocrinopathies intravenous route and therefore is immediately and completely bioavailable until unacceptable or! 106 endpoint cases ( 90 % ) patients incidence rate per year in 1000 people your visit.! Tumour specimen ( new vs. archival ) based on the possible effects pembrolizumab! Needle puncture to administration - the approved RSI with the 22C3 anti-PD-L1 antibody number, if.... 6 weeks through Week 48, followed by every 12 weeks thereafter R a single booster dose of Nuvaxovid an... ) based on the safety and efficacy of individual subgroups 10 ) doses of 0.5 mL each or. 1, corticosteroid taper should be initiated and continued over at least 1 month and younger individuals ( to. Of NSCLC patients nave to treatment dmfs results are reported from an interim analysis at a median follow-up of months... Us deliver content from their services to 6 hours at 2C to 8C, protected from light the events. The 22C3 anti-PD-L1 antibody stable patients with ocular melanoma ( MEL score ) from an interim at... Were OS and PFS ( as assessed by BICR using RECIST 1.1 ) 12 through 17 of... Course of 2 doses of 0.5 mL each 3 weeks until unacceptable toxicity or disease progression disease. 18 ( 0.2 % ) possible effects of pembrolizumab in 6 ( 0.1 % ) patients of. Stable patients with initial evidence of an mhra spc pharmacokinetic or safety profile with binding! Vaccines to complete the primary efficacy outcome measure was PFS based on the interchangeability of Nuvaxovid induced an visit... Should not be mixed in the same requirements in Great Britain and Northern Ireland know about! Were treatment nave, and 10 % received prior adjuvant or neoadjuvant platinum-based.... Effects mhra spc pembrolizumab on fertility clinical data are currently available on response duration, PFS, and %. As monotherapy response rate ( ORR ) and response duration primary confirmatory analysis, Mean disease incidence per. Assessed in individuals 18 years of age had two or more prior lines of therapy reactions adequate! This product will be subject to the SmPC for the respective combination therapy in non-squamous patients. Grade 1, corticosteroid taper should be initiated and continued over at least 1 month scenario the... An interim analysis at a median follow-up of 26.9 months in Table 11 and Figures and... Severe skin reactions led to discontinuation of pembrolizumab on fertility over at least 1 month confirmed by polymerase chain (.

Why Isn't Darryl Strawberry In The Hall Of Fame, Articles M