FDA's oncology office uses advisory committee to spotlight timely accelerated approval...

cafead

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  • cafead   Nov 15, 2023 at 11:32: AM
via An upcoming meeting of the FDA’s oncologic drugs advisory committee is slated to serve as a reminder for cancer drug developers that the agency is keeping a close eye on accelerated approvals.

External experts invited by the FDA will discuss during a meeting Thursday two accelerated approvals by Acrotech Biopharma. The two nods are for Folotyn and Beleodaq in relapsed or refractory peripheral T-cell lymphoma (PTCL), granted in 2009 and 2014, respectively.

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