Lilly gets FDA approval for Alimta combination

The US Food and Drug Administration has granted approval for a new indication for Eli Lilly’s (NYSE: LLY) Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status.

Under the FDA's accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck & Co (NYSE: MRK), the developer of Keytruda – which generated sales of over $3.8 billion in 2017 - received accelerated approval for the combination of pembrolizumab with Alimta and carboplatin in May 2017. This is the first and only combination of chemotherapy and immunotherapy to earn FDA approval for the first-line treatment of metastatic non-squamous NSCLC. This indication, now included in the Alimta prescribing information, is based on data from Merck's KEYNOTE-021 study, Cohort G1. Alimta recorded full-year 2017 sales of $2.06 billion.