FDA Grants Novel Treatment for Acute Myeloid Leukemia Fast Track Designation

The Food and Drug Administration (FDA) has granted a fast track designation to BST-236 (aspacytarabine) to treat adults aged 75 years or older with acute myeloid leukemia (AML), or who have comorbidities that prevent the use of intensive induction chemotherapy.

“Receiving Fast Track designation from the FDA is an important recognition of the potential of BST-236 to address the significant unmet need in the population of AML patients who are medically unfit to receive intensive chemotherapy, and to improve the outcomes for these patients,” said Dr. Ruth Ben Yakar, Biosight Ltd.’s chief executive officer, in a company-issued press release.

The agency grants fast track designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to its website. This designation has the potential to lead to an accelerated approval for a drug.

Patients are currently being enrolled into a phase 2b study to evaluate BST-236 as a first-line treatment option for patients with AML who are unfit to receive standard chemotherapy.

BST-236 is a novel proprietary antimetabolite which is designed to provide patients the benefits of intensive chemotherapy, but without the toxic side effects.

“The compelling safety and efficacy data from both a completed phase 1/2a and ongoing phase 2b studies of BST-236, may establish it as a new intensive therapy backbone of AML and may, for the first time, allow older adults deemed unfit for standard chemotherapy, to benefit from an intensive treatment,” concluded Yakar in a press release.