FDA expands label of Alimta + Keytruda for the first-line treatment of metastatic nonsquamous NSCLC.- Eli Lilly + Merck inc.

Eli Lilly and Company announced that the FDA has granted approval for a new indication for Alimta (pemetrexed for injection) in combination with Keytruda (pembrolizumab), developed and marketed by Merck and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

This indication is approved based on data from Merck's Phase III KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival (OS) and progression-free survival (PFS).

Alimta in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and PFS data from the Phase II study KEYNOTE-021 (Cohort G1). In accordance with the accelerated approval process, continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in the KEYNOTE-189 trial and has resulted in the FDA converting the accelerated approval to full (regular) approval.