Posted by Michael Wonder on 05 Jun 2018
FDA expands Lilly's Alimta (pemetrexed) label to include combination with Keytruda (pembrolizumab) and carboplatin as first-line treatment for metastatic non-squamous non-small cell lung cancer, irrespective of PD-L1 expression
5 June 2018 - New approval based on KEYNOTE-021, cohort G1, results.
Eli Lilly today announced that the U.S. FDA has granted approval for a new indication for 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 tumour response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck 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.
