Incyte's Zynyz Secures Dual FDA Approvals for Anal Cancer, Marking Significant Milestone in Treatment Landscape

Incyte Corporation has achieved a major breakthrough in the treatment of squamous cell carcinoma of the anal canal (SCAC) with the U.S. Food and Drug Administration (FDA) granting two concurrent approvals for its PD-1 inhibitor, Zynyz. This development comes four years after an initial rejection by the agency, representing a significant turnaround for the company and a new hope for patients battling this rare form of cancer.

First-Line Approval and Monotherapy Indication

The FDA has approved Zynyz in combination with carboplatin and paclitaxel as a first-line treatment for patients with inoperable locally recurrent or metastatic SCAC. This makes Zynyz the first PD-1 blocker in the United States to receive approval for this indication, according to Incyte CEO Hervé Hoppenot.

Simultaneously, the agency has given the green light for Zynyz as a monotherapy for SCAC patients who are intolerant to platinum-based chemotherapy or whose disease has progressed. This dual approval significantly expands the treatment options available to patients at different stages of the disease.

Clinical Trial Data Supporting Approval

The approvals are backed by compelling data from two clinical trials. The Phase III POD1UM-303 trial demonstrated that Zynyz, when combined with platinum-based chemotherapy, reduced the risk of disease progression or death by 37% compared to chemotherapy alone. The study also showed a favorable trend in overall survival, with a 30% reduction in the risk of death, although this result did not reach statistical significance.

For the monotherapy indication, the single-arm POD1UM-202 trial showed an objective response rate of 14% in 94 patients with platinum-refractory or intolerant anal cancer. The duration of response lasted a median of 9.5 months.

Market Impact and Future Outlook

While Zynyz's approval in SCAC represents a significant clinical advancement, its financial impact on Incyte's portfolio remains to be seen. In the first quarter of 2025, Zynyz generated $3 million in sales, a modest figure compared to Incyte's total revenue of approximately $1 billion for the same period.

Incyte's CEO has described Zynyz as an "opportunistic product" aimed at enabling first-line access to PD-1 drugs in markets outside the U.S. and Europe. The company does not expect Zynyz to be a major revenue driver, but its approval in SCAC could pave the way for broader applications in the future.

As Incyte continues to expand its oncology portfolio, the success of Zynyz in SCAC represents a pivotal moment in the treatment landscape for this rare and challenging cancer. The dual approvals not only validate Incyte's persistence following the initial FDA rejection but also offer new hope to patients facing limited treatment options.