On December 9, 2022, #FDA has approved #Atezolizumab for adult and pediatric unresectable or metastatic #alveolar soft part #sarcoma (ASPS).

The approval was based on the open-label, single-arm #ML39345 study which enrolled 49 adult and pediatric patients with unresectable or metastatic ASPS to receive single agent atezolizumab with adult dose: 840 mg biweekly, 1200 mg / 3 weeks, or 1680 mg / 4 weeks, and for pediatrics 2 years of age and older, 15 mg/kg (Max 1200 mg) every 3 weeks till disease progression or unacceptable toxicity.

The primary endpoint of ORR was 24% ; among whom 67% had a response of 6 months or more, and 42% had a response of 12 months or more. The application was granted orphan drug designation and was granted priority review and breakthrough designation.