Treats previously treated, unresectable locally advanced or metastatic cholangiocarcinoma…. NDA 213736, held by Incyte Corp. Pemigatinib.
As of Nov 13, 2026, NDA 213736 (Pemazyre), held by Incyte Corp, was first approved by FDA on Apr 17, 2020, with 2 approved supplements and 0 published complete response letters.
PEMAZYRE is a kinase inhibitor 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. ( 1, 2.1 ) 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). ( 1, 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1, 2.1 ) 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pemazyre4.5MG · tablet;oral | Pemigatinib | RxReference drug |
| Pemazyre9MG · tablet;oral | Pemigatinib | RxReference drug |
| Pemazyre13.5MG · tablet;oral | Pemigatinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2022 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Feb 23, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Apr 17, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
