FDA Approves Merck’s KEYTRUDA (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

As quoted in the press release:

This indication is approved under the FDA’s accelerated approval regulations 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 confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy. With this indication, KEYTRUDA becomes the first anti-PD-1 therapy to be approved for the treatment of PMBCL, a type of non-Hodgkin lymphoma. This is the second indication for KEYTRUDA for the treatment of a hematologic malignancy.

“Relapsed or refractory PMBCL is often a challenging disease to treat, and many affected patients are young adults,” said Philippe Armand, M.D., Ph.D., medical oncologist in the Hematologic Oncology Treatment Center at Dana-Farber Cancer Institute. “In the clinical trial that supported this approval, treatment with KEYTRUDA resulted in meaningful responses, including complete disease remission in some patients. This approval therefore provides another therapeutic option for patients with PMBCL who have progressed on or after prior therapies.”

Click here to read the full press release.