On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) approved Genentech’s atezolizumab (Tecentriq) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma. The FDA approved this application 3 weeks ahead of the FDA goal date.

Efficacy was evaluated in Study ML39345 (NCT03141684), an open-label, single-arm study in 49 adult and pediatric patients with unresectable or metastatic ASPS. This application was granted priority review and breakthrough designation.