FDA greenlights Genentech’s Tecentriq Hybreza

The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche (ROG: SIX) subsidiary Genentech announced yesterday.

Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). It will be available for all IV indications of Tecentriq approved for adults in the USA, including certain types of lung, liver, skin and soft tissue cancer.

The FDA decision follows a request from the regulator last year for Roche to resubmit its application for SC Tecentriq with updated information on the chemistry, manufacturing and controls (CMC) processes "in line with evolved" requirements from the agency.