Pemazyre (pemigatinib)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pemigatinib
- Company
- Incyte Biosciences Distribution B.V.
- Status
- Authorised
- Therapeutic area
- Cholangiocarcinoma
- CHMP opinion
- Thu 28 Jan 2021
- EU approval
- Fri 26 Mar 2021
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/005266
- ATC
- L01EN02
- Official record
- www.ema.europa.eu
Indication
Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.