Pemazyre FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 31, 2022.
FDA Approved: Yes (First approved April 17, 2020)
Brand name: Pemazyre
Generic name: pemigatinib
Dosage form: Tablets
Company: Incyte Corporation
Treatment for: Cholangiocarcinoma, Myeloid/Lymphoid Neoplasms
Pemazyre (pemigatinib) is a selective fibroblast growth factor receptor (FGFR) inhibitor for the treatment of adults with cholangiocarcinoma with FGFR2 rearrangement, and myeloid/lymphoid neoplasms with FGFR1 rearrangement.
- Pemazyre is indicated:
- for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
- for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- Pemazyre tablets are administered orally, once daily.
In cholangiocarcinoma, tablets are taken for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Treatment is continued until disease progression or unacceptable toxicity occurs.
In myeloid/lymphoid neoplasms with FGFR1 rearrangement, tablets are taken once daily. Treatment is continued until disease progression or unacceptable toxicity occurs. - Pemazyre is associated with the following warnings and precautions: ocular toxicity; hyperphosphatemia and soft tissue mineralization; and embryo-fetal toxicity.
- Common adverse reactions in cholangiocarcinoma patients 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.
Common adverse reactions in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement include hyperphosphatemia, nail toxicity, alopecia, stomatitis, diarrhea, dry eye, fatigue, rash, abdominal pain, anemia, constipation, dry mouth, epistaxis, serous retinal detachment, extremity pain, decreased appetite, dry skin, dyspepsia, back pain, nausea, blurred vision, peripheral edema, and dizziness.
Development timeline for Pemazyre
Further information
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