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Home » FDA Approves First Treatment and Drug Specifically for PEComa
FDA Approves First Treatment and Drug Specifically for PEComa
The FDA has approved the first treatment specifically for patients with an ultra-rare and aggressive form of cancer seen mostly in women.
Made by Aadi Bioscience and called Fyarro, the treatment, sirolimus protein-bound particles for injectable suspension, is aimed at people with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
The approval was based on a phase 2 trial of 31 patients in which Fyarro showed an overall response rate of 39 percent, with two patients achieving a complete response after prolonged followup, Aadi said.
Among patients who responded to the drug, 92 percent had a response lasting greater than or equal to six months, while 67 percent had a response lasting longer than or equal to 12 months, and 58 percent had a response lasting greater than or equal to two years, the company said.
Aadi said it’s planning Fyarro’s launch in the first quarter of 2022.
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