Today, Amgen announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval for its leukemia drug.
Specifically, the company submitted the application for its investigational cancer immunotherapy blinatumomab for treatment of adult patients with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressive cancer of the blood and bone marrow. Amgen’s blinatumomab has been granted orphan drug designation and awarded with breakthrough therapy designation from the FDA, intended to expedite review of the drug.
“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 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.”
Blinatumomab is an investigational bispecific T cell engager (BiTE) antibody construct. BiTE® antibody constructs represent an innovative immunotherapy approach that helps the body’s immune system targeting cancer cells.
Amgen’s application includes data from a mid-stage trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint, with 43 percent of patients achieving complete remission or complete remission with partial hematologic recovery within two cycles of treatment with blinatumomab. Results were presented at the American Society of Clinical Oncology (ASCO) meeting.
“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.”
ALL progresses rapidly and affects immature blood cells. Worldwide, the disease accounts for more than 12 percent of leukemia cases. Among the 42,000 people diagnosed with ALL worldwide, 31,000 will die from the disease. Patients with ALL have abnormal white blood cells, also known as lymphocytes, that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and other serious side effects.
Last updated: 9/22/14; 11:15am EST