FDA approves Incyte’s new anal cancer treatment
Ella Day | May 20, 2025 | News story | Research and Development | FDA, Incyte Corporation, Oncology, Orphan Drug Designation (ODD), Zynyz, fast track designation, priority review
The US Food and Drug Administration (FDA) has approved Incyte Corporation’s immunotherapy retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel to treat inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Zynyz has also been approved as a monotherapy for patients who have progressed on or are intolerant to platinum-based chemotherapy. The drug has also received Orphan Drug, Fast Track and Priority Review Designations from the FDA.
The approval is based on data from the phase 3 POD1UM-303/InterAACT 2 trial. Results showed that patients receiving the Zynyz combination experienced a median progression-free survival of 9.3 months versus 7.4 months for placebo.
Zynyz as a monotherapy was evaluated in the POD1UM-202 trial. The objective response rate was 14% with a median duration of response of 9.5 months.
Incyte is a biopharma that develops therapies in oncology, inflammation and autoimmunity. It focuses on pursuing medical advancements for patients with limited treatment options.
SCAC is a rare disease, affecting around 1,600 people a year in the UK, though it has rising malignancy with limited treatment options. Until now, platinum-based chemotherapy has been the standard of care with few effective alternatives for patients who relapse or cannot tolerate treatment. The approval of Zynyz introduces a much-needed option for these patients.
Ella Day
20/5/25
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
