Efficacy of sirolimus albumin-bound nanoparticle injection (FYARRO)

On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus albumin-bound nanoparticle injection (FYARRO) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors. The approval was based on a multicenter, single-arm clinical trial (AMPECT) that evaluated efficacy in 31 patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors.

Patients received an infusion of 100 mg/m2 sirolimus albumin-bound nanoparticle injection on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. The primary efficacy outcome measures were overall response rate and duration of response, assessed by blinded independent central review using RECIST v.1.1. The overall response rate was 39%, including 2 patients with complete responses. The median duration of response was not reached. Among responders, 67% had a response lasting more than 12 months and 58% had a response longer than 24 months.

The original drug of sirolimus albumin-bound nanoparticle injection has not yet been marketed in China, so it is not included in medical insurance. The US version of sirolimus albumin-bound nanoparticle injection Original drug, specifications The price of each 100mg tube may be around RMB 60,000 (the price may fluctuate due to the exchange rate), which is relatively expensive. Currently, there is no generic version of Sirolimus Albumin-Bound Nanoparticle Injection on the market. For more drug information and specific prices, please consult Yaode Medical Consultants.