Retifanlimab
Retifanlimab (Zynyz, Incyte Biosciences Distribution B.V.) has 2 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Anal cancer1 | |||
None | + carboplatin and paclitaxel | 1L advanced | Squamous cell carcinoma only |
| Merkel cell carcinoma1 | |||
None | Monotherapy | 1L advanced | Not amenable to curative surgery or radiation therapy |
Full text of section 4.1 (therapeutic indications)
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.
Label history
2 changes to the Zynyz label since 2026, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes