Forty Seven announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to its lead candidate, 5F9, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), two forms of B-cell non-Hodgkin lymphoma (NHL). 5F9 is a monoclonal antibody against CD47 that is designed to block the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages.
"The FDA's decision to grant Fast Track designations to 5F9 for the treatment of DLBCL and FL reflects the urgent need for safe and effective therapies for people living with these cancers, and the potential of 5F9 to help patients for whom existing options are limited," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. "We look forward to working closely with the FDA as we advance our ongoing Phase 2 trial of 5F9 in combination with rituximab and continue to learn about the safety and efficacy profile of 5F9 in patients with B-cell NHL."
Data justifying these Fast Track designations were derived from an open-label, multi-center Phase 1b/2 clinical trial of 5F9 in combination with rituximab in patients with relapsed or refractory B-cell NHL, including DLBCL and FL. Forty Seven expects to announce initial safety and efficacy data from the Phase 1b portion of the trial in the second quarter of 2018.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of medicines that may treat serious or life-threatening conditions and address significant unmet medical needs. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met, as well as for Rolling Review, which enables a drug company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete.
Forty Seven is also evaluating 5F9 as a monotherapy in a Phase 1 trial in patients with ovarian cancer and other solid tumors, in combination with azacytidine in a Phase 1/1b trial in patients with refractory acute myeloid leukemia (AML) and in combination with cetuximab in a Phase 1b/2 trial in patients with advanced relapsed or refractory solid tumors, including colorectal cancer. Forty Seven also plans to initiate Phase 1b clinical trials evaluating 5F9 in combination with avelumab in patients with ovarian cancer and evaluating 5F9 in combination with atezolizumab in patients with bladder cancer.