The US Food and Drug Administration (FDA) has approved Incyte’s humanised monoclonal antibody Zynyz (retifanlimab-dlwr) in conjunction with carboplatin and paclitaxel (platinum-based chemo) for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
The agency approved Zynyz as a monotherapy for treating adults with locally recurrent or metastatic SCAC who have progression of the disease or are not tolerant to platinum-based chemotherapy.
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The regulator’s priority review and the supplemental biologics licence application (sBLA) approval of the antibody were supported by data from the Phase III POD1UM-303/InterAACT2 trial and the Phase II POD1UM-202 trial.
The Phase III trial assessed the antibody with carboplatin and paclitaxel in adults with metastatic or inoperable locally recurrent SCAC who had not received previous systemic chemotherapy.
Additionally, the Phase II POD1UM-202 trial assessed the antibody as a monotherapy.
SCAC is the prevalent form of anal cancer, and human papillomavirus (HPV) infection is considered as a major risk factor.
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By GlobalDataIncyte CEO Hervé Hoppenot statedd: “The FDA approval of Zynyz marks a pivotal moment, bringing effective combination and monotherapy treatment options to patients with advanced anal cancer after decades of limited innovation.”
Incyte has pursued regulatory approvals beyond the US, submitting a Type II variation marketing authorisation application to the European Medicines Agency for retifanlimab’s use in advanced SCAC.
The Japanese new drug application submitted by the company has been accepted by the Pharmaceuticals and Medical Devices Agency for the same use.
Zynyz has an additional indication in the US for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
This indication has been granted accelerated approval based on duration of response and tumour response rate, with continued approval contingent upon further clinical benefit verification in confirmatory studies.
Incyte markets Zynyz in the US. In 2017, the company signed a partnership and licence agreement for worldwide rights of the antibody with MacroGenics.
In February 2025, Incyte entered a strategic partnership with Genesis Therapeutics to research and develop new small-molecule medicines.
