US EditionFDA Grants First Approval to First-Line Therapy for Advanced Anal Cancer
- The FDA approved retifanlimab-dlwr in May 2025 for first-line and monotherapy treatment of advanced squamous cell anal carcinoma in the United States.
- This approval follows a previous rejection in 2021 and is supported by data demonstrating that retifanlimab combined with chemotherapy improves outcomes for patients with inoperable, locally recurrent, or metastatic disease, as shown in the pivotal phase 3 trial evaluating this combination in untreated SCAC patients.
- The trial enrolled 308 chemotherapy-naive patients and found retifanlimab plus carboplatin and paclitaxel reduced progression or death risk by 37% and extended median progression-free survival to 9.3 months versus 7.4 months with chemotherapy alone.
- Interim overall survival was 29.2 months with retifanlimab versus 23 months with placebo, with a hazard ratio of 0.70 and statistical significance reached , although follow-up is ongoing.
- This approval creates a new treatment option for a rare, HPV-linked cancer with limited therapies, potentially improving outcomes and signaling progress in an overlooked disease area.
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25 Articles
The Elkhart Truth
FDA Approves Zynyz as First-Line Treatment for Advanced Anal Cancer
WEDNESDAY, May 21, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved the humanized monoclonal antibody, Zynyz, (retifanlimab-dlwr) as the first first-line treatment for advanced anal cancer.
Incyte’s Zynyz receives FDA approval for advanced anal cancer treatment
Incyte's drug Zynyz has become the first treatment specifically approved by the FDA for first-line anal cancer - four years after it was rejected by the regulators. The post Incyte’s Zynyz receives FDA approval for advanced anal cancer treatment appeared first on Delaware Business Times.
MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA Grants First Approval to First-Line Therapy for Advanced Anal Cancer
(MedPage Today) -- The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday. The approval stipulates use in combination with carboplatin and paclitaxel...
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