FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection, for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared to 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). It will be available for all of Tecentriq’s IV indications approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancers.

“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice in treatment administration,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients more quickly and in more accessible settings.”