FDA Grants Keytruda Fourth Breakthrough Therapy Status

Designation is supported by data from ongoing Phase 1b and Phase 2 studies
Designation is supported by data from ongoing Phase 1b and Phase 2 studies

Merck announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

The designation in cHL is supported by data from the ongoing Phase 1b KEYNOTE-013 and the Phase 2 KEYNOTE-087 studies evaluating Keytruda monotherapy in patients with cHL. Study data from KEYNOTE-013 were presented at the 2015 American Society of Hematology (ASH) Annual Meeting. Findings from the KEYNOTE-087 study will be presented at an upcoming scientific meeting.

RELATED: FDA to Review Study Data for Keytruda NSCLC Indication 

Previous Breakthrough Therapy designations for Keytruda included indications for advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.

Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody. It is currently indicated for the treatment of patients with unresectable or metastatic melanoma and for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.

For more information call (800) 672–6372 or visit Merck.com.

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