How Infigratinib Was Evaluated by the FDA to Expedite Approval Process for Treatment of Cholangiocarcinoma

July 7, 2021

Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed how the US FDA evaluated the application for infigratinib to expedite the approval process for treatment of previously treated locally advanced or metastatic cholangiocarcinoma.

Pharmacy Times interviewed Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, on the phase 2 trial results that led to the US FDA approval of infigratinib (Truseltiq, QED Therapeutics) for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

During this discussion, Javle addressed how the US FDA evaluated the application for infigratinib to expedite the approval process for treatment in this patient population.