FDA Grants Pembrolizumab Accelerated Approval For Classical HL

The U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab for the treatment of children and adults with refractory classical Hodgkin lymphoma, or those who have relapsed after receiving three or more prior lines of therapy.

The approval was supported by data from the KEYNOTE-087 trial, which included patients who relapsed after autologous hematopoietic cell transplantation (n=129) and/or brentuximab vedotin (n=175). Patients had received a median of four prior therapies (range = 1-12). At 9.4-month follow up, the overall response rate was 69 percent (95% CI 62-75).

The most common adverse events (observed in >20%) were: fatigue, pyrexia, cough, musculoskeletal pain, diarrhea, rash, and hypertransaminasemia.

A “warning and precaution” was added to the labeling as a result of complications of allogeneic hematopoietic cell transplantation (HCT) after pembrolizumab, including death. Health-care professionals are advised to closely monitor patients for early evidence of transplant-related complications, such as hyperacute graft-versus-host-disease (GVHD), severe (grade 3/4) acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. FDA has required the sponsor to further study the safety of allogeneic HCT after pembrolizumab therapy.

Source: FDA news release, March 14, 2017.