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About KEYTRUDA in mNSCLC
About KEYTRUDA® (pembrolizumab) in metastatic non-small cell lung cancer
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
GB-PDO-02703 | Date of Preparation: August 2023
NICE = National Institute For Health And Care Excellence.
Pembrolizumab is recommended as an option for untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (with at least a 50% tumour proportion score) and have no epidermal growth factor receptor-or anaplastic lymphoma kinase-positive mutations, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression and the company provides pembrolizumab according to the commercial access agreement.2
Pembrolizumab is recommended as an option for treating locally advanced or metastatic PD-L1-positive non-small-cell lung cancer in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [ALK]-positive tumour), only if pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression, and the company provides pembrolizumab in line with the commercial access agreement with NHS England.3
Pembrolizumab, with pemetrexed and platinum chemotherapy, is recommended as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)- positive mutations, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and the company provides pembrolizumab according to the commercial arrangement.4
Pembrolizumab with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, if their tumours express PD-L1 with a tumour proportion score less than 50%, their tumours express PD-L1 with a tumour proportion score of 50% or more and they need urgent clinical intervention, and it is stopped at 2 years of uninterrupted treatment or earlier if their disease progresses.5
SMC = Scottish Medicines Consortium.
Pembrolizumab is accepted for restricted use within NHS Scotland as monotherapy for the first‑line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.6
Pembrolizumab is accepted for restricted use within NHS Scotland for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one prior chemotherapy regimen. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.7
Pembrolizumab is accepted for restricted use within NHS Scotland in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small-cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations and whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.8
Pembrolizumab is accepted for restricted use within NHS Scotland in combination with carboplatin and either paclitaxel or nabpaclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.9
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.1
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.1
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.1
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.1
The recommended dose of KEYTRUDA as monotherapy or as part of combination therapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. KEYTRUDA should be administered first when given in combination with intravenous chemotherapy.1
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References
- KEYTRUDA Summary of Product Characteristics.
- National Institute for Health and Care Excellence (2018). TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta531. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
- National Institute for Health and Care Excellence (2017). TA428: Pembrolizumab for treating PD-L1 positive non-small-cell lung cancer after chemotherapy. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/TA428. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
- National Institute for Health and Care Excellence (2021). Final appraisal determination: Pembrolizumab with pemetrexed and platinum-based chemotherapy for untreated non-small-cell lung cancer (CDF Review of TA557) [ID1584] Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10529. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the user of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
- National Institute for Health and Care Excellence (2022). Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer. Available from: https://www.nice.org.uk/guidance/ta770. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the user of its content in this document to confirm that it accurately reflects the NICE publication from with it is taken.
- Scottish Medicines Consortium (2017). Pembrolizumab for untreated PD-L1 positive metastatic non-small-cell lung cancer. Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-123917/.
- Scottish Medicines Consortium (2017). Appraisal determination: Pembrolizumab 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-120417/.
- Scottish Medicines Consortium (2019). Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-resub-smc2207/.
- Scottish Medicines Consortium (2019). Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2187/.
Supporting documentation
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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