Roche subcutaneous cancer immunotherapy granted MHRA approval

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq^® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration.

“Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” stated Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

Tecentriq SC will be available on the NHS in Great Britain for certain types of lung, bladder, breast, and liver cancer.

Clinical data for Tecentriq SC

Approval of the monoclonal antibody is based on clinical data from the Phase IB/III IMscin001 study. The study enrolled 371 patients who had experienced failure of prior platinum therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC).

Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously. The safety and efficacy profile was consistent with the IV formulation.

Subcutaneous formulation of Roche’s cancer immunotherapy

The subcutaneous formulation of Roche’s cancer immunotherapy was co-formulated with Halozyme Therapeutics and based on Halozyme’s drug delivery technology which uses a recombinant human hyaluronidase enzyme.

Tecentriq is designed to bind with a protein called programmed death ligand-1 (PD-L1), blocking its interactions with both PD-1 and B7.1 receptors. Inhibition of PD-L1 means Tecentriq may enable the activation of T-cells, which support the body’s immune system.

Tecentriq was the first cancer immunotherapy approved for a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).

Regulators worldwide, including the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) are currently evaluating the subcutaneous drug formulation of Tecentriq for approval.

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