Amgen Submits BLA for Investigational BiTE Immunotherapy Blinatumomab

Amgen has submitted a Biologics License Application (BLA) to FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells. Blinatumomab, the first of the BiTE antibody constructs, has received both orphan drug designation and breakthrough therapy designation from FDA for the treatment of ALL. 

"We look forward to working with regulatory authorities to make blinatumomab available for adult patients with acute lymphoblastic leukemia, who experience high relapse rates and have limited treatment options," said Sean E. Harper, MD, Executive Vice President of R&D at Amgen. "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."

The submission includes data from a Phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.

"Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL," said Anthony S. Stein, MD, clinical professor, Hematology/Oncology at City of Hope. "Blinatumomab has the potential to significantly advance treatment options for patients living with this difficult-to-treat disease, and the BLA submission marks an important step toward achieving this goal."