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FDA grants priority review to Keytruda for advanced gastric, gastroesophageal junction adenocarcinoma
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The FDA granted priority review to pembrolizumab for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma, according to the drug’s manufacturer.
The designation applies to use of pembrolizumab (Keytruda, Merck) — a humanized monoclonal antibody that blocks the interaction of PD-1 and its ligands — for patients who received at least two lines of chemotherapy.
The FDA is expected to make a decision on the application by Sept. 22.
“Nearly 100,000 people are living with gastric cancer in the United States, yet little progress has been made in bringing forward new treatment options to these patients for whom chemotherapy has long been the standard of care,” Roger D. Dansey, MD, senior vice president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said in a company-issued press release. “We look forward to working with the FDA to bring Keytruda to people with gastric cancer who have progressed after receiving chemotherapy and are in urgent need of another option.”
The company’s supplemental biologics license application seeks approval of pembrolizumab monotherapy at a fixed dose of 200 mg via IV every 3 weeks.
The application is based on results from the phase 2 KEYNOTE-059 trial, which included a cohort of patients with heavily pretreated recurrent or advanced gastric or gastroesophageal junction adenocarcinoma that progressed after at least two prior lines of chemotherapy. Data from that cohort will be presented at the ASCO Annual Meeting, which will be held June 2-6 in Chicago.
On May 23, the FDA granted accelerated approval to pembrolizumab for treatment of adults and children with unresectable or metastatic, microsatellite instability–high or mismatch repair–deficient solid tumors.
Pembrolizumab also is approved for several other indications, including treatment of certain patients with unresectable or metastatic melanoma, metastatic non–small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, classical Hodgkin lymphoma and urothelial carcinoma.