BerGenBio’s Bemcentinib Receives the US FDA’s Fast Track Designation for Relapsed Acute Myeloid Leukemia
Shots:
- The US FDA has approved FT designation for Bemcentinib to treat elderly patients with acute myeloid leukemia (AML) whose disease has relapsed
- The FDA’s Fast Track designation facilitates the development and expedite the review of therapy to treat serious conditions and fill an unmet medical need
- Bemcentinib (BGB324) is a first-in-class selective AXL inhibitor, currently being evaluated in P-II study for AML. BerGenBio plan to seek regulatory advice from the US FDA & EMA to determine the optimal regulatory path for Bemcentinib in relapsed AML
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