European Commission Approves Roche’s Tecentriq SC

Roche have stated that the European Commission has granted marketing authorisation for Tecentriq SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection. Last year, more than 38,000 people in the EU received Tecentriq to treat different types of lung, liver, bladder and breast cancer. Until now, Tecentriq has been given directly into patients’ veins by IV infusion which takes approximately 30-60 minutes. The new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes. The marketing authorisation applies to all approved indications of Tecentriq IV.

“We are pleased to introduce the first subcutaneous PD-L1 cancer immunotherapy in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.”

“Ensuring the best possible quality of life is crucial for people living with cancer,” said Dr. Enriqueta Felip, Head of the Thoracic Cancer Unit of Vall d'Hebron Hospital, Spain. “The availability of a subcutaneous cancer immunotherapy option that can minimise the time receiving treatment and even allow for treatment outside of a hospital will undoubtedly make a significant difference to patients and their loved ones.”

The 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. 90% of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation.

In addition to offering shorter treatment time, Tecentriq SC may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home, depending on national regulations and health systems. Roche is in discussion with several providers in Europe to include Tecentriq SC in cancer homecare initiatives where possible.