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Pemazyre FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 8, 2020.

FDA Approved: Yes (First approved April 17, 2020)
Brand name: Pemazyre
Generic name: pemigatinib
Dosage form: Tablets
Company: Incyte Corporation
Treatment for: Cholangiocarcinoma

Pemazyre (pemigatinib) is a selective fibroblast growth factor receptor (FGFR) inhibitor for the treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, as detected by an FDA-approved test.

  • Pemazyre was approved under accelerated approval based on tumor response. Data are not yet available to show if Pemazyre improves survival or symptoms. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).
  • Approval was based on data from the FIGHT-202 study. Results showed that patients receiving Pemazyre monotherapy demonstrated an overall response rate of 36%, and median duration of response of 9.1 months.
  • Pemazyre is administered as oral tablets, taken once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Treatment is continued until disease progression or unacceptable toxicity occurs.
  • Common adverse reactions include hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, and dry skin.

Development Timeline for Pemazyre

Apr 17, 2020Approval  FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma
Dec  1, 2019Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
Nov 27, 2019Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma
Oct 21, 2019Innovent Biologics Announces Positive Updated Result from the Incyte-sponsored Phase II Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma
Sep 27, 2019Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma
Oct 21, 2018Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma

Further information

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