Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did not flag problems with the drug’s efficacy or safety.
The FDA has rejected Incyte’s supplemental application to add non-small cell lung cancer to the label of its anti-PD-1 antibody Zynyz, citing manufacturing issues at Novo Nordisk’s Catalent-acquired site.
In its complete response letter, the regulator pointed to “inspection findings” at Catalent Indiana, a manufacturing facility owned and operated by Novo, as the reason for the rejection, according to a Friday SEC filing. The FDA cited “the regulatory compliance of Catalent Indiana as the sole approvability issue,” Incyte said, noting that the regulator “did not cite other approvability concerns” such as the drug’s efficacy and safety data.
The company is currently “working closely” with the FDA and Catalent Indiana to address the issues raised in the rejection letter. Incyte did not provide a specific timeline for when it expects to refile the application for Zynyz.
Novo acquired contract development and manufacturing organization Catalent in February 2024.
Designed to be administered via an intravenous infusion, Zynyz is a monoclonal antibody that works by targeting and blocking the PD-1 receptor. It was first approved in 2023 for Merkel cell carcinoma. In May last year, the FDA cleared Zynyz as a first-line therapy for patients with advanced anal cancer.
To back its supplemental application in non-small cell lung cancer, Incyte filed data from the Phase 3 POD1UM-304 study, which enrolled more than 580 treatment-naïve patients with stage 4 disease. The trial combined Zynyz with chemotherapy, including pemetrexed, cisplatin and carboplatin. Controls were given a placebo plus chemotherapy.
Data released in December 2024 showed that patients given the Zynyz regimen saw a 25% improvement in overall survival, the study’s primary outcome, resulting in a statistically significant treatment effect. Zynyz also aced key secondary endpoints, including progression-free survival and overall response rate.
The Zynyz rejection isn’t the first linked to Novo’s Indiana site, which in August 2025 was revealed to have had long-standing unresolved violations, including contamination with cat hair, pest infestations and unaddressed equipment failures. In October 2025, the FDA deemed the plant to be in an “unacceptable state of compliance” and gave it the Official Action Indicated classification—the agency’s most severe alert for such facilities.
In September 2025, issues at this facility led to the rejection of Scholar Rock’s apitegromab, which it was proposing for spinal muscular atrophy. A few weeks later, the agency also turned down a pre-filled syringe formulation of Regeneron’s high-dose Eylea due to the Catalent-acquired plant.
