• Safi Bello

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Adult and Pediatric Patients with Classical Hodgk

Merck press release Tuesday March 14, 2017 -------- Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In refractory or relapsed cHL, KEYTRUDA is approved for use in adult patients at a fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg (up to a maximum of 200 mg). KEYTRUDA is administered intravenously every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. To get more in depth information click on the picture below to read the release.

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