Sirolimus protein-bound particles is approved for malignant perivascular epithelioid cell tumor

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Jan 2022: For adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumours, the Food and Drug Administration licenced sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) (PEComa).

Efficacy was tested in 31 patients with locally advanced unresectable or metastatic malignant PEComa in AMPECT (NCT02494570), a multicenter, single-arm clinical study. On days 1 and 8 of each 21-day cycle, patients received 100 mg/m2 sirolimus protein-bound particles until disease progression or intolerable toxicity.

Overall response rate (ORR) and duration of response (DOR) were the key efficacy outcome measures, as determined by a blinded independent central review using RECIST v.1.1. The ORR was 39 percent (95 percent CI: 22 percent, 58 percent), with two patients responding completely. The median DOR was not met (95 percent CI: 6.5 months, not estimable). 67 percent of respondents had a response that lasted more than 12 months, and 58 percent had a response that lasted more than 24 months.

Stomatitis, weariness, rash, infection, nausea, edoema, diarrhoea, musculoskeletal discomfort, decreased weight, decreased appetite, cough, vomiting, and dysgeusia were the most prevalent side events (30 percent). Decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased haemoglobin, and elevated lipase were the most prevalent grade 3 to 4 laboratory abnormalities (6%).

Until disease progression or intolerable toxicity, the recommended dosage is 100 mg/m2 given as an IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle.

 

Click this link for full prescribing information for Fyarro.

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