FDA Oks Genentech's Tecentriq Hybreza As First & Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration 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. It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer.

Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).

"By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration," said Levi Garraway, chief medical officer and head of Global Product Development.

The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in over 50 countries (outside the U.S. marketed as Tecentriq SC). Regulatory reviews in other countries and regions are ongoing.

For More Such Health News, visit rttnews.com.