FDA Approves Zynyz for Subset of Patients With Rare Skin Cancer


This FDA approval of Zynyz was based on findings from a study which demonstrated that the therapy improves responses in patients with locally advanced Merkel cell carcinoma.

The Food and Drug Administration has approved the PD-1 inhibitor Zynyz (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a rare type of skin cancer.

MCC typically presents as a single, reddish-purple skin nodule on the head, neck and arms in areas of the body exposed to sunlight, according to a press release from Incyte, the drug’s manufacturer. It can grow quickly and is likely to metastasize, or spread to another part of the body.

“Zynyz offers patients and health care providers an additional first-line anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat,” Hervé Hoppenot, chief executive officer of Incyte, said in the release.

This FDA approval was based on findings from the PODIUM-201 study, according to a release from the agency. In the study, 65 patients with metastatic or recurrent locally advanced (cancer that spread to nearby tissues or lymph nodes) MCC who did not receive prior therapy for advanced disease were treated with Zynyz.

The objective response rate (the percentage of patients with a partial or complete response to treatment) was 52%, with 18% of patients obtaining a complete response (the disappearance of all signs of cancer from treatment). In addition, 76% of patients had a duration of response to treatment of at least six months, and 62% continued to respond to treatment for at least 12 months, according to the FDA’s release.

“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” Dr. Shailender Bhatia, director of the melanoma and renal cancer team at Fred Hutchinson Cancer Center in Seattle, said in the release. “The approval of Zynyz offers health care providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease.”

The most common side effects patients in the PODIUM-201 study experienced were musculoskeletal pain, fatigue, diarrhea, itchy skin, fever, rash and nausea. Serious side effects occurred in 22% of patients from the study, according to the company’s release. The most frequent serious side effects include fatigue, pneumonitis (inflamed lung tissue) and arrhythmia (irregular heartbeat).

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