Incyte Gets FDA Approval for Zynyz in New Cancer Indication
Incyte INCY announced that the FDA has approved its new drug, Zynyz (retifanlimab-dlwr), a PD-1 inhibitor, for treating a new cancer indication. The regulatory body has now approved Zynyz in combination with platinum-based chemotherapy (carboplatin and paclitaxel) for the first-line treatment of adult patients with locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
Simultaneously, the FDA also approved Zynyz as a monotherapy for treating locally recurrent or metastatic SCAC in adult patients whose disease progressed on or who are intolerant to platinum-based chemotherapy.
Following the latest FDA nod, Zynyz became the first and only first-line treatment to be approved for advanced anal cancer in the United States. Zynyz was approved in the United States for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma in March 2023. Year to date, shares of Incyte have lost 9.1% compared with the industry’s decline of 10.2%.
Approval of New Drugs Diversifies INCY's Portfolio
The latest FDA approval for Zynyz was based on data from two studies. The phase III POD1UM-303/InterAACT2 study evaluated Zynyz in combination with platinum-based chemotherapy in adult patients with metastatic SCAC, while the phase II POD1UM-202 study investigated Zynyz as a monotherapy in previously treated patients with locally advanced or metastatic SCAC.
Data from the POD1UM-303/InterAACT2 study showed that treatment with the combo of Zynyz plus chemotherapy led to a clinically meaningful and statistically significant reduction of 37% in the risk of progression or death. Data from the POD1UM-202 study showed that treatment with Zynyz monotherapy led to an objective response rate (ORR) of 14% and a disease control rate of 49%.
INCY has also submitted a Type II variation marketing authorization application for Zynyz to the European Medicines Agency for treating advanced SCAC. Zynyz generated sales worth $3 million in the first quarter of 2025. The approval for SCAC should boost sales of the drug in future quarters.
We note that approval of new drugs is likely to reduce Incyte’s heavy dependence on the lead drug Jakafi.
Jakafi, a first-in-class JAK1/JAK2 inhibitor, is approved for treating polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease. The drug generated sales worth $709.4 million in the first quarter of 2025, up 24% year over year. Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. INCY receives royalties from Novartis for the commercialization of Jakavi in ex-U.S. markets.
