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FDA grants priority review to Keytruda for Hodgkin lymphoma
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The FDA granted priority review to pembrolizumab for the treatment of patients with refractory classical Hodgkin lymphoma or for patients who have relapsed after three or more prior lines of therapy, according to the drug’s manufacturer.
The indication includes a fixed dose of 200 mg administered intravenously every 3 weeks based on data from the KEYNOTE-087 and KEYNOTE-013 trials.
“Patients with refractory or relapsed classical Hodgkin lymphoma have limited treatment options,” Roger Dansey, MD, senior vice president and therapeutic area head of the oncology late-stage development team at Merck Research Laboratories, said in a press release. “We believe that the expedited review of this supplemental biologics license application granted by the FDA is an important step in helping us make pembrolizumab available as quickly as possible to patients living with this disease.”
The target action date is set for March 15, 2017.
Pembrolizumab is approved for the treatment of patients with unresectable or metastatic melanoma, certain patients with metastatic non–small cell lung cancer, and patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.