Posted by Michael Wonder on 11 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic non-squamous non-small-cell lung cancer, irrespective of PD-L1 expression
10 May 2017 - First approval for an anti-PD-1 therapy as a combination in metastatic non-squamous NSCLC.
Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic non-squamous NSCLC, irrespective of PD-L1 expression.
Under the FDA’s accelerated approval regulations, this indication is approved based on tumour 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.
