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FDA grants priority review to Keytruda in combination with chemotherapy for advanced NSCLC
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The FDA granted priority review to a supplemental biologics license application for pembrolizumab in combination with chemotherapy for first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer, according to the drug’s manufacturer.
The application seeks approval of pembrolizumab (Keytruda, Merck), an anti–PD-1 therapy, in combination with pemetrexed and carboplatin regardless of patients’ PD-L1 expression, provided they have no EGFR or ALK mutations.
The FDA is expected to make a decision by May 10.
“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” Roger Dansey, MD, senior vice president and therapeutic area head of oncology late-stage development for Merck Research Laboratories, said in a press release. “[Pembrolizumab] in combination with chemotherapy has shown promise vs. chemotherapy alone in the first-line treatment of nonsquamous metastatic non–small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non–small cell lung cancer.”
The application — based on results from the KEYNOTE-021 study, presented in October at the European Society for Medical Oncology Congress — seeks approval of pembrolizumab at a dose of 200 mg via IV every 3 weeks, in combination with pemetrexed 500 mg/m2 administered via IV infusion every 3 weeks, as well as carboplatin area under the curve 5 mg/mL per minute every 3 weeks for four cycles.
The FDA previously approved pembrolizumab for treatment of unresectable or metastatic melanoma; first-line treatment of metastatic NSCLC whose tumors have high PD-L1 expression; treatment of patients with metastatic, PD-L1–expressing NSCLC that progressed on or after platinum-containing chemotherapy; and treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy.