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FDA Grants Priority Review to Pemigatinib for FGFR2+ Cholangiocarcinoma

Gina Columbus @ginacolumbusonc
Published: Wednesday, Nov 27, 2019

Regarding safety, AEs were found to be manageable and consistent with the mechanism of action of pemigatinib. The most common AE was hyperphosphatemia (60%), but no grade ≥3 cases were encountered. Hyperphosphatemia was managed with a low phosphate diet, phosphate binders, diuretics, and a reduction or interruption in the pemigatinib dose. Three patients required dose reductions/interruptions due to hyperphosphatemia.

 

References

  1. Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma. Incyte. Published November 27, 2019. https://bit.ly/35KAHZf. Accessed November 27, 2019.
  2. Hollebecque A, Borad M, Sahai V, et al. FIGHT-202: a phase 2 study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA). Presented at: 2019 ESMO Congress; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA40.

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