Amgen Submits BLA To FDA For Blinatumomab Immunotherapy In Leukemia
By Cyndi Root
Amgen has applied to the FDA for a Biologics License Application (BLA) for blinatumomab, an investigational immunotherapy. The company announced the BLA for the bispecific T cell engager (BiTE) antibody construct in a press release. The agent has already been granted Orphan Drug designation and Breakthrough Therapy designation from the FDA for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a cancer of the blood and bone marrow. Amgen’s BLA application includes data from a Phase 2 trial of adults with ALL, which met its primary endpoint.
Sean E. Harper, M.D., EVP of Research and Development at Amgen, said, "The filing for blinatumomab brings us a step closer to first realizing the potential of BiTE technology and represents our commitment to evaluating this novel approach in a broad range of difficult-to-treat cancers."
Blinatumomab
Blinatumomab is an antibody construct, the first using Amgen’s BiTE technology. It has two antigen-recognition sites, which work together to mediate cell death. The
BiTE antibody constructs engage targets at the same time, helping the immune system detect and kill malignant cells. The BiTE agents show promise in treating many different kinds of cancer.
A Phase 3 trial is underway, titled, “Trial of Blinatumomab vs. Investigator's Choice of Chemotherapy In Patients With Relapsed Or Refractory ALL.” The randomized, open label study will evaluate about 400 adults at multiple sites. Patients will be administered blinatumomab or chemotherapy. The primary endpoint is Overall Survival (OS) and the study includes 15 other measures designated as safety issues. Amgen expects data on the primary outcome measure in May 2016 with final results in July 2017.
Amgen Activities
Amgen continues to move its pipeline forward including Prolia and Romosozumab in osteoporosis, Ivabradine in chronic heart failure, and Kyprolis in myeloma. However, in July 2014, the company announced that it was closing sites in Seattle. The Seattle Times reports that the move is part of larger efforts to reorganize. Amgen will close facilities in Boulder and Longmont, CO. The company’s headquarters will remain in Southern California and it will redirect focus to facilities in Boston and San Francisco.