The Food and Drug Administration has rejected Incyte’s supplemental application to expand the use of its anti-PD-1 antibody Zynyz for non-small cell lung cancer, citing manufacturing problems at Novo Nordisk’s Catalent-acquired facility in Indiana, according to a March 9 statement.
The decision is significant because it delays the potential availability of a new treatment option for patients with advanced non-small cell lung cancer. The FDA's complete response letter pointed to inspection findings at Catalent Indiana as the only reason for the rejection. Incyte said, “the regulatory compliance of Catalent Indiana as the sole approvability issue,” and noted that the agency “did not cite other approvability concerns” such as efficacy or safety data.
Incyte stated it is “working closely” with both the FDA and Catalent Indiana to resolve the issues but did not provide a timeline for refiling its application. Novo Nordisk acquired contract development and manufacturing organization Catalent in February 2024.
Zynyz, administered by intravenous infusion, is a monoclonal antibody targeting the PD-1 receptor. It was first approved in 2023 for Merkel cell carcinoma and later cleared by the FDA in May last year as a first-line therapy for advanced anal cancer. For its latest application, Incyte submitted data from a Phase 3 study involving more than 580 patients with stage 4 disease. Results released in December 2024 showed that Zynyz combined with chemotherapy improved overall survival by 25% compared to placebo plus chemotherapy, meeting primary and key secondary endpoints.
This is not the first time issues at Novo’s Indiana site have led to regulatory setbacks. In August 2025, unresolved violations including contamination with cat hair, pest infestations, and equipment failures were reported at the facility. By October 2025, the FDA classified it as being in an “unacceptable state of compliance.” Previous rejections linked to this plant include Scholar Rock’s apitegromab for spinal muscular atrophy and Regeneron’s high-dose Eylea pre-filled syringe formulation.
