Europe - Positive CHMP Opinion for for Roche's Tecentriq's subcutaneous formulation in all IV indications

Roche has announced the EMA's CHMP has granted a positive Opinion for its subcutaneous injection of Tecentriq (atezolizumab), in all its appoved IV indications.

This approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.

As a reminder, Tecentriq is already approved in Urothelial carcinoma (UC), Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Hepatocellular carcinoma (HCC) and Triple-negative breast cancer (TNBC).

Reference link: Roche press release