Halozyme Therapeutics, Inc. announced that Roche received European Commission (EC) marketing authorization of Tecentriq® SC (atezolizumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. The approval applies to all approved indications of Tecentriq® IV and represents the European Union (EU)'s first PD-(L)1 cancer immunotherapy for subcutaneous injection. Tecentriq® SC reduces treatment time to approximately 7 minutes, compared to an IV infusion which can take approximately 30 to 60 minutes.

In addition, it may be administered by a healthcare professional outside of the hospital, in a community care setting or at home, depending on national regulations and health systems. The EC approval follows 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. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation.