Pemazyre FDA Approval History
Reviewed by Judith Stewart BPharm. Last updated on April 20, 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
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