FDA Reviews Application for Keytruda in Mediastinal B-cell Lymphoma

FDA Reviews Application for Keytruda in Mediastinal B-cell Lymphoma

The U.S. Food and Drug Administration (FDA) agreed to review Merck’s application to add relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL) to the list of cancers treated with Keytruda (pembrolizumab).

The agency granted the application priority review status, and said it will make a decision before April 3, 2018.

The move was supported by data from the Phase 2 KEYNOTE-170 trial (NCT02576990), which researchers presented to the scientific community on Dec. 10, at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta.

If approved, Keytruda will become a treatment option for both adults and children with PMBCL who have relapsed or are refractory to two or more earlier treatments.

“There is a significant unmet need for patients with relapsed or refractory primary mediastinal large B-cell lymphoma,” Pier Luigi Zinzani, MD, PhD, said in a press release. Zinzani is associate professor of hematology at the Institute of Hematology “L. e A. Seràgnoli” at the University of Bologna in Italy.

“These encouraging results represent another step in understanding the potential of Keytruda to help these patients who have already tried and progressed on prior therapies,” he added.

Merck — known as MSD outside the U.S. and Canada — previously received breakthrough therapy designation for Keytruda for the treatment of PMBCL.

The KEYNOTE-170 study showed that 41 percent of its 29 patients responded to the treatment, with 24 percent having a complete eradication of the cancer. An additional 17 percent had a partial response.

In addition, the FDA considered data from the Phase 1b KEYNOTE-013 trial (NCT01953692) — a study of Keytruda in various blood cancers that included PMBCL patients.

“These findings in patients with PMBCL are promising for a rare lymphoma that affects mainly young adults and has few effective treatment options in the relapsed or refractory treatment setting,” said Roger Dansey, PhD, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.

“If approved by the FDA, this would be our second blood cancer indication for Keytruda, following FDA approval for certain patients with classical Hodgkin Lymphoma earlier this year. The acceptance of our sBLA [supplemental Biologics License Application] reinforces our ongoing commitment to finding new treatment advances in hematology.”

Keytruda is a so-called checkpoint inhibitor that acts by unleashing the body’s own immune system to fight a cancer, by acting on the PD-1 factor. It is approved for numerous cancers, including melanoma, lung cancer, and head and neck cancer.

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