Incyte’s Zynyz Secures Approval for Anal Cancer—A Comeback After FDA Rejection
Following two simultaneous FDA approvals, Incyte’s PD-1 inhibitor Zynyz has made a comeback in the treatment of anal cancer, four years after being initially rejected by the agency. On May 15, 2025, Incyte announced that the FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody that targets the PD-1, for use in combination with carboplatin and paclitaxel as a first-line treatment for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC).
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The therapy for aHUS is primarily supportive, focusing on managing acute kidney injury and systemic complications, with renal replacement therapy required for patients with uremia, fluid overload, or electrolyte abnormalities. Specific treatments include plasma exchange and complement inhibitors like eculizumab and ravulizumab, the only two approved drugs for aHUS treatment. In 2023, the total market size for aHUS in the United States was ~USD 900 million and is projected to surpass USD 1.5 billion by 2034, growing at a CAGR of 4.5% from 2020 to 2034. Among emerging therapies, PIASKY (crovalimab) and FABHALTA (iptacopan) are expected to significantly impact the market.
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