Roche's One Of Largest Selling Cancer Drug Approved Under The Skin Injection Version In Europe

Tuesday, the European Commission approved Roche Holdings AG’s RHHBY 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.

In 2022, Tecentriq generated global sales of CHF 3.7 billion, up 14%.

The new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes.

The marketing authorization 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, 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.”

Also Read: Roche Agrees To Purchase Part Of COVID-19 Test Player LumiraDx Diagnostics Platform For $295M.

The approval is based on pivotal data from the Phase 1B/3 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.

Roche is discussing with several European providers to include Tecentriq SC in cancer homecare initiatives where possible.

Tecentriq SC combines Tecentriq with Halozyme Therapeutics Inc’s HALO Enhanze drug delivery technology. 

Tecentriq SC was first approved in Great Britain in August 2023. The approved indications for Tecentriq SC mirror those of Tecentriq IV. 

Price Action: HALO shares are up 4.10% at $35.84 on the last check Tuesday.