Zynyz (retifanlimab)
- Region
- 🇪🇺 EU
- Active substance
- retifanlimab
- Company
- Incyte Biosciences Distribution B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Merkel Cell
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006194
- ATC
- L01FF10
- Official record
- www.ema.europa.eu
Indication
Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC) Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zynyz Application withdrawn · Incyte Biosciences Distribution B.V.
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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.