Incyte granted FDA approval of Zynyz for SCAC

The US Food and Drug Administration (FDA) has approved Incyte’s (Nasdaq: INCY) Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).

In addition, the FDA granted approval for Zynyz as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

This approval comes after the FDA initially denied Zynyz second-line (2L) + monotherapy approval in 2021 due to concerns around the modest ORR (14%), exacerbated by the single arm trial design of POD1UM-202.