Incyte의 Zynyz, 폐암서 FDA 제동…항문암은 유럽 승인 확보
Incyte는 Zynyz의 폐암 적응증과 관련해 제3자 제조 시설 문제로 FDA로부터 보완요구서한(Complete Response Letter)을 받았다. 반면 Zynyz는 항문암 치료에서는 POD1UM-303 3상 데이터를 근거로 EMA 산하 CHMP의 긍정적 의견을 바탕으로 유럽 승인을 확보했다.
On February 27, the U.S. Food and Drug Administration issued a Complete Response Letter for Incyte Corporation's supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) injection in combination with platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer. The FDA's letter cited inspection findings related to Catalent Indiana, LLC, a third-party fill-finish facility referenced in the application. The regulatory compliance issue at Catalent Indiana, which is part of Novo Nordisk, was identified as the sole approvability issue.
The FDA did not cite concerns regarding the efficacy or safety data for Zynyz in this indication, nor did it reference issues with the third-party drug substance manufacturer. The application for Zynyz was supported by data from the Phase 3 POD1UM-304 trial, which was previously announced in December 2024. Incyte stated that it is working with the FDA and Catalent Indiana to address the Complete Response Letter and support a potential resubmission of the application for Zynyz in metastatic non-small cell lung cancer.
In contrast, Zynyz has received a recommendation for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This recommendation targets the treatment of a specific form of anal cancer. The CHMP's positive opinion is grounded in data from the Phase 3 POD1UM-303 clinical trial. This study evaluated Zynyz in combination with a standard chemotherapy regimen for patients diagnosed with metastatic or inoperable squamous cell carcinoma of the anal canal.
Results demonstrated that the combination therapy reduced the risk of disease progression or death by 37% compared to chemotherapy alone. Patients receiving the new combination achieved a median progression-free survival of 9.3 months, a notable improvement over the 7.4 months observed in the control group. The European Commission will now review the CHMP recommendation for final marketing authorization. A green light would substantially widen the drug's commercial reach, complementing its existing approvals for similar indications in the United States and Japan.
The European Commission has approved Zynyz for the treatment of advanced squamous cell carcinoma of the anal canal, marking the first systemic treatment option available in Europe for this condition. Incyte reported fourth-quarter 2025 earnings with revenue of $1.51 billion, surpassing the forecast of $1.35 billion, despite earnings per share falling short of expectations at $1.80 compared to the projected $1.91.
Incyte faces a looming wave of patent expirations on several of its top-selling legacy drugs in the coming years. The company's recent full-year 2025 financial report, released on February 10, underscores this strategic emphasis on research and development. Management has outlined an ambitious plan to advance 14 registration-enabling studies across seven different drug candidates simultaneously by the end of 2026.