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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation and priority review to Merck’s Keytruda (pembrolizumab) for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1.
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The agency's action date (PDUFA) is 24 December 2016.
Merck has filed a marketing application in Europe for the similar indication.
The data supporting the submissions was generated in the Phase 3 Keynote-024 study under which Keytruda monotherapy demonstrated superior progression-free survival and overall survival compared to standard chemo.
Based on these results, Merck halted the trial early to offer patients on the chemotherapy arm the opportunity to receive Keytruda.
Merck Research Laboratories president Roger Perlmutter said: “Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news.
“We appreciate the opportunity to work with regulatory authorities to make Keytruda a first-line treatment option in non-small cell lung cancer.”
Last month, the European Commission approved Keytruda to treat patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) following at least 1 chemotherapy regimen.
Keytruda increases the ability of the body’s immune system to help identify and fight tumor cells.
It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which could affect both tumor cells and healthy cells.
Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.