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FDA grants fast track designation to bemcentinib for acute myeloid leukemia
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The FDA granted bemcentinib fast track designation for the treatment of elderly patients with relapsed acute myeloid leukemia, the agent’s manufacturer announced in a press release.
Bemcentinib (BerGenBio) — an investigational selective AXL inhibitor — is being evaluated as monotherapy and in combination with immunotherapies, targeted therapies and chemotherapy in a phase 2 clinical development program with trials for multiple hematologic malignancies and solid tumors. The agent works by targeting and binding to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase, thereby inhibiting its activity, which is linked to mechanisms of drug resistance and immune escape by tumor cells.
“We are thrilled that bemcentinib has been granted fast track designation,” Richard Godfrey, CEO of BerGenBio, said in the release. “Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of bemcentinib in this significant unmet medical need we are trying to address. Currently, bemcentinib is in expanded phase 2 trials in the U.S. and Europe for the treatment of AML, and the company has recently announced positive interim top line data.”