BerGenBio’s Bemcentinib Receives the US FDA’s Fast Track Designation for Relapsed Acute Myeloid Leukemia

 BerGenBio’s Bemcentinib Receives the US FDA’s Fast Track Designation for Relapsed Acute Myeloid Leukemia

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Visinnovasjon

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