Amgen Asks FDA For Biologics License For Breakthrough Cancer Drug Blinatumomab

September 23, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Amgen announced on this week that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for the approval of leukemia drug blinatumomab.

Blinatumomab is a bispecific T cell engager antibody construct. Amgen submitted its BLA on Monday to the FDA for the treatment of adults who have Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.

"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 Harper, executive vice president of Research and Development 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."

Amgen, which is headquartered in California, is focused on discovering, developing, manufacturing and delivering human therapeutics. It uses tools like advanced human genetics to determine the complexities of diseases and uncover the fundamentals of human biology.

The bispecific T cell engager antibody constructs are representative of an immunotherapy approach that encourages the body’s own immune system to fight cancer cells. Blinatumomab has received orphan drug designation and breakthrough therapy designation from the FDA. The breakthrough therapy designation is meant to expedite the review of drugs for serious or life-threatening conditions.

"Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL," said Anthony Stein, clinical professor of 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."

The bispecific T cell engager places T cells within reach of a targeted cell with the intent of allowing T cells to inject toxins. In turn, this triggers cancer cells to die. Currently, bispecific T cell engagers are being examined for the treatment of a wide variety of cancers.

Blinatumomab is an investigational bispecific T cell engager antibody construct that is being investigated for the potential to treat pediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive B-precursor ALL, minimal residual disease positive B-precursor ALL, and relapsed/refractory non-Hodgkin's lymphoma, including relapsed/refractory diffuse large B-cell lymphoma.