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Evidence summaries: new medicines – Integrated process statement (PMG11)
This integrated process statement has been produced to explain how 'Evidence summaries: new medicines' (ESNMs) are developed. It provides an overview of the key process principles and describes all stages of the development of ESNMs
Evidence-based recommendations on tisagenlecleucel (Kymriah) for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 25 years and under.
Selpercatinib for untreated RET fusion-positive advanced non-small-cell lung cancer (TA911)
Evidence-based recommendations on selpercatinib (Retsevmo) for untreated RET fusion-positive advanced non-small-cell lung cancer in adults.
Evidence-based recommendations on brigatinib (Alunbrig) for anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor.
Evidence-based recommendations on lutetium-177 vipivotide tetraxetan (Pluvicto) for treating prostate-specific membrane antigen-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments in adults.
Pegcetacoplan for treating paroxysmal nocturnal haemoglobinuria (TA778)
Evidence-based recommendations on pegcetacoplan (Aspaveli) for treating paroxysmal nocturnal haemoglobinuria in adults who have anaemia after at least 3 months of treatment with a C5 inhibitor.
Topic prioritisation
Drug-eluting stents for the treatment of coronary artery disease (TA152)
Evidence-based recommendations on using drug-eluting stents in adults.
Evidence-based recommendations on abiraterone (Zytiga) for castration-resistant metastatic prostate cancer in adults who have had previous treatment with a docetaxel-containing regimen.
Cabozantinib for previously treated advanced renal cell carcinoma (TA463)
Evidence-based recommendations on cabozantinib (Cabometyx) for previously treated advance renal cell carcinoma in adults.
Topic prioritisation
Nivolumab with ipilimumab for untreated advanced renal cell carcinoma (TA780)
Evidence-based recommendations on nivolumab (Opdivo) with ipilimumab (Yervoy) for untreated advanced renal cell carcinoma in adults.
Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer (TA531)
Evidence-based recommendations on pembrolizumab (Keytruda) for untreated PD-L1-positive metastatic non-small-cell lung cancer in adults.
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Evidence-based recommendations on dabrafenib (Tafinlar) plus trametinib (Mekinist) for BRAF V600 mutation-positive advanced non-small-cell lung cancer in adults.