Keytruda-chemotherapy combination gets CHMP nod

The committee has recommended Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous NSCLC lung cancer in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression.

The approval is based on overall survival (OS) and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial.

"There is significant need for innovative therapies that can improve the overall survival of patients suffering from metastatic non-small cell lung cancer, as lung cancer is the leading cause of cancer deaths in Europe," said Dr Roger Perlmutter, president of MSD Research Laboratories.

The CHMP also adopted a positive opinion recommending approval of Keytruda as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a tumour proportion score (TPS) of ≥50 percent, and who progressed on or after exposure to platinum-based chemotherapy.

These two recommendations will now be reviewed by the European Commission for marketing authorisation in the EU. A final decision on both recommendations is expected in the third quarter of 2018.

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