FDA grants fast track designation to BST-236 for acute myeloid leukemia
The FDA granted fast track designation to BST-236 for the treatment of adults with acute myeloid leukemia who are aged 75 years or older or cannot receive induction chemotherapy, according to a press release from the agent’s manufacturer.
BST-236 (aspacytarabine, BioSight) is a novel antimetabolite composed of cytarabine covalently bound to asparagine. The agent is designed to provide high-dose therapy with lower systemic exposure to cytarabine in order to reduce toxicities and damage to normal tissue. This is especially relevant to older patients with AML, who often are unable to undergo intensive induction chemotherapy due to their comorbidities.
The agent is currently under investigation in a phase 2b study as a single agent for first-line treatment of patients unfit for standard chemotherapy. Another phase 2 trial of BST-236 in patients with relapsed/refractory myelodysplastic syndrome or AML is expected to begin later this year.
“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 [patients with AML] who are medically unfit to receive intensive chemotherapy, and to improve the outcomes for these patients” Ruth Ben Yakar, PhD, CEO of BioSight, said in the release. “The compelling safety and efficacy data from both a completed phase 1/phase 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.”