Amgen, a biotechnology company developing and delivering innovative human therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for blinatumomab, the investigational bispecific T cell engager (BiTE) antibody construct, for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). Moreover, a Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL.
BiTE antibodies are a specific immunotherapy that can help the patient’s immune system to fight cancer, by detecting and targeting tumor cells.
These engineered antibodies have the capacity to engage two different targets at the same time, therefore allowing T lymphocytes to optimally engage in they cytotoxic potential, eliminating malignant cells through apoptosis.
Blinatumomab is an investigational BiTE® antibody construct designed to direct T cells against tumor cells expressing CD19, a receptor commonly found on the surface of B-cell derived leukemias and lymphomas.
The BiTE antibody technology has received orphan drug designation from the FDA for the treatment of several types of leukemias and lymphomas, alongside a priority review with a Prescription Drug User Fee Act (PDUFA) action date of May 19, 2015.
“The FDA’s acceptance of our BLA submission and designation of priority review for blinatumomab underscores the need to provide new treatment approaches for adult patients with relapsed or refractory ALL, and we are encouraged by the Agency’s expedited review,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said in a company’s press release. “Blinatumomab has the potential to make a significant impact for these patients, and this milestone, along with other ongoing filings around the world, represents the potential of BiTE® technology in cancers that are challenging to treat.”
The submission to the FDA is based on recent data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.