The U.S. Food and Drug Administration has accepted for review a supplemental Biologics Licence Application (sBLA) seeking the approval of Keytruda (pembrulizumab) for the treatment of patients with refractory classical Hodgkin’s lymphoma, or who have relapsed following three or more lines of therapy.
The FDA will give the request a priority review, and set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 15, 2017.
“Patients with refractory or relapsed classical Hodgkin lymphoma have limited treatment options,” Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said in a press release. “We believe that the expedited review of this sBLA granted by the FDA is an important step in helping us make Keytruda available as quickly as possible to patients living with this disease.”
The application is based on data from the KEYNOTE-087 Phase 2 trial (NCT02453594) and the KEYNOTE-013 Phase 1b trial (NCT01953692), which assessed the safety and efficacy of Keytruda (200 mg dose, every three weeks) in patients with refractory classical Hodgkin lymphoma or who relapsed after at least three prior lines of therapy.
Data from the KEYNOTE-087 trial, presented in June at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, has shown promising anti-tumor activity, with overall response rates that ranged from 73% to 83%, and with 27% to 30% of patients achieving a complete response.
Similarly, the KEYNOTE-013 trial revealed an overall patient response rate of 66%, with 21% achieving a complete response, and 86% showing clinical benefit.
Keytruda was previously designated a Breakthrough Therapy for this indication by the FDA, and if the sBLA application is approved, classical Hodgkin’s lymphoma will become the first hematological malignancy to be treated with Keytruda, an anti-PD-1 therapy.
Keytruda is a humanized monoclonal antibody that increases the immune system’s ability to detect and fight tumor cells. It works by blocking the interactions between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T-lymphocytes.
This therapy is currently approved for specific subsets of melanoma, lung, and head and neck cancers. It has been or is being tested in more than 30 tumor types in some 360 clinical trials, including as a combination cancer therapy in 200 of these studies. For hematological malignancies, in particular, Merck is conducting nearly 40 studies, including registration-enabling trials, of Keytruda as a combination or monotherapy in more than 20 hematological diseases.