Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s best-selling cancer immunotherapy.
As the first subcutaneously administered PD-(L)1 cancer immunotherapy in the European Union, Tecentriq SC offers a significant reduction in treatment time, decreasing from up to 60 minutes required for intravenous therapies to a mere 7 minutes. This innovation also eliminates the need for a healthcare professional to administer the treatment, potentially easing the burden on healthcare resources in strained systems.
The approval was based on clinical data demonstrating that Tecentriq SC has comparable blood levels, overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety profile to its intravenous counterpart in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).- Flcube.com
