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New FDA Approval for KEYTRUDA®

On March 14, 2017, Merck 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. 

Click Here to read the entire Press Release. 

Additional Information:

Announcement Letter

Approval Letter

Prescribing Information

Medication Guide