The U.S. Food and Drug Administration has issued a Complete Response Letter for Incyte Corporation’s supplemental Biologics License Application seeking approval of Zynyz in combination with platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer.
The regulatory decision represents a setback for the company’s effort to expand the use of Zynyz, also known as retifanlimab-dlwr, into lung cancer treatment. The application aimed to allow the drug to be used alongside standard platinum-based chemotherapy in patients whose disease has spread beyond the lungs.
According to the company, the FDA’s decision was not based on concerns about the drug’s clinical performance. Instead, the agency cited inspection findings involving Catalent Indiana, LLC, a third-party fill-finish manufacturing facility referenced in the submission. The compliance issue at the facility was identified as the only reason preventing approval of the lung cancer application.
The facility involved is part of Novo Nordisk’s manufacturing network. The FDA did not raise any concerns related to the efficacy or safety results of Zynyz in lung cancer patients. The agency also did not identify issues involving the third-party manufacturer responsible for producing the drug substance.
The application was supported by results from the Phase 3 POD1UM-304 clinical trial. Data from the study were previously announced in December 2024 and were intended to demonstrate the potential benefit of combining Zynyz with platinum-based chemotherapy in patients with metastatic non-small cell lung cancer.
Following the regulatory update, analysts adjusted their outlook for the company’s near-term financial performance. Several analysts lowered earnings estimates for the upcoming reporting period as the delay may push back potential revenue from the lung cancer indication.
Incyte said it is working with both the FDA and Catalent Indiana to address the manufacturing compliance issues raised in the Complete Response Letter. The company plans to take corrective steps and support a future resubmission of the application for the lung cancer treatment.
The regulatory development comes alongside other recent milestones for the company. European regulators recently approved Zynyz for the treatment of advanced squamous cell carcinoma of the anal canal, providing a new systemic therapy option in Europe for that disease.
In addition, Incyte and its partner Eli Lilly and Company received a positive opinion from European regulators for Olumiant as a treatment for severe alopecia areata in adolescents. The company has also reported strong financial performance, with fourth-quarter 2025 revenue reaching $1.51 billion, exceeding market forecasts even though earnings per share came in slightly below expectations.
Investment analysts remain divided on the company’s outlook. Some firms have reiterated positive ratings and price targets after the company reported full-year revenue of $5.14 billion, which exceeded consensus estimates. Others have maintained more cautious positions while awaiting further regulatory progress and revenue growth from new product approvals.
