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news.Merck has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) seeking approval for its anti-PD-1 therapy, Keytruda (pembrolizumab), to treat advanced non-small cell lung cancer (NSCLC).
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Earlier, Keytruda received breakthrough therapy designation for advanced NSCLC and this sBLA seeks approval to treat these NSCLC patients whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present.
Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has 60 days from submission of the sBLA to determine if the application will be accepted for review.
The sBLA is based on data from KEYNOTE-001 in patients with greater than or equal to 50% of tumor cells positive for PD-L1 expression.
Merck Research Laboratories president Dr Roger Perlmutter said: "We are encouraged by the new KEYNOTE-001 data evaluating KEYTRUDA in patients with advanced non-small cell lung cancer, which will be presented today at AACR Annual Meeting.
"We look forward to the FDA’s review of our supplemental application for KEYTRUDA, which is based in part on these data."
A Premarket Approval Application (PMA) was submitted by Dako North America, an Agilent Technologies Company, for an immunohistochemistry companion diagnostic test that detects PD-L1 expression, PD-L1 IHC 22C3 PharmDx.
In the US, Keytruda is indicated at a dose of 2mg/kg administered as an intravenous infusion over 30 minutes every three weeks to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.