WILMINGTON — Incyte, one of Delaware’s top pharmaceutical companies, has secured U.S. Food and Drug Administration (FDA) approval to use Zynyz as a treatment for anal cancer.
Zynyz, an intravenous PD-1 inhibitor, may now be used in combination with platinum-based chemotherapy as well as a monotherapy for metastatic squamous cell carcinoma (SCAC), which makes up the majority of anal cancer prognosis. Thirteen percent of the patients diagnosed with it have a 5-year overall survival rate, according to studies by the National Institutes of Health.
Anal cancer itself is very rare, with 10,040 new cases diagnosed in 2024, according to the American Cancer Society. But SCAC accounts for 85% of those cases.
Incyte said the regulatory approval was a major victory for the pharmaceutical company, calling Zynyz the first and only FDA-approved “first-line treatment for advanced anal cancer in the U.S.”
Incyte CEO Hervé Hoppenot said that the approval has come at a “pivotal moment” for patients with advanced anal cancer after decades of limited innovation.
“At Incyte, we focus our efforts where we can make the biggest impact for patients. I am proud of our scientists and development teams for their perseverance in delivering the first approved PD-1 inhibitor to U.S. patients with SCAC,” Hoppenot said in a press statement.
The Thursday announcement comes four years after federal regulators rejected Incyte’s bid to use Zynyz as a single agent for patients with anal cancer that has progressed or for patients who are intolerant to platinum-based chemo. In 2023, the drug was first approved for metastatic, recurrent or locally advanced Merkel cell carcinoma.
At the end of last year, Incyte revealed clinical trials that found Zynyz had reduced the risk of disease progression or death in combination with chemotherapy by 37%. Additional studies on overall survival rate are ongoing.
Incyte is also seeking approval for Zynyz in SCAC in the European Union and Japan.
While a notable win as Incyte races to find treatment options while exclusive commercialization rights for its blockbuster drug Jakafi expire in three years, Zynyz is a small piece to the company’s future. Zynyz brought in just $3 million in sales out of about $1 billion for Incyte in the first quarter of 2025.
