Amgen Seeks Approval for Breakthrough Leukemia Drug

Amgen has submitted a new drug application to the FDA for its novel leukemia candidate, blinatumomab, following promising Phase 2 trials results.

The investigational bispecific T cell engager (BiTE) previously received both orphan drug and breakthrough therapy designation from the FDA for the treatment of adult patients with acute lymphoblastic leukemia (ALL). Recently, the drug successfully met its primary endpoint in a Phase 2 trial of ALL patients treated with blinatumomab.

“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,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a press release. “We look forward to working with regulatory authorities to make blinatumomab available for adult patients with ALL, who experience high relapse rates and have limited treatment options.”

According to Amgen, it has been estimated that more than 6,000 ALL diagnoses will be made in the United States this year. The median overall survival for adult patients with relapsed or refractory ALL is just 3 to 5 months, the company noted.

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