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FDA grants breakthrough therapy designation to Keytruda for NSCLC
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The FDA granted breakthrough therapy designation to pembrolizumab for the treatment of patients with epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangement-negative non–small cell lung cancer who received at least one prior platinum-containing chemotherapy, Merck announced.
The FDA used interim efficacy and safety results from an ongoing phase 1b KEYNOTE-001 study of pembrolizumab (Keytruda) and data presented at the European Society of Medical Oncology 2014 Congress to base the designation, which is intended to expedite development and review of drugs to treat serious or life-threatening conditions.
Roger M. Perlmutter
“The FDA’s breakthrough therapy designation of Keytruda underscores that new treatment approaches for advanced non–small cell lung cancer continue to be needed,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “Our data investigating the use of Keytruda in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical program.”
Pembrolizumab is currently indicated for patients with advanced or unresectable melanoma following progression with ipilimumab (Yervoy, Bristol-Myers Squibb). Among patients whose tumors harbor a BRAF V600 mutation, pembrolizumab is intended to follow treatment with ipilimumab and a BRAF inhibitor.
Although this indication is approved under accelerated approval based on tumor response rate and durability of response, an improvement in survival or disease-associated symptoms has not yet been confirmed.