Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types.

The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion.

The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer.

The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU.

Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer. SC administration offers a faster and more convenient alternative to IV infusion.”

The CHMP’s positive opinion was supported by results from the phase 1b/3 IMscin001 study, which demonstrated comparable levels of Tecentriq in the blood when administered subcutaneously, as well as a safety and efficacy profile consistent with the IV formulation.

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

“The CHMP’s recommendation brings us a step closer to offering the first SC PD-L1 cancer immunotherapy treatment to patients in the EU,” said Garraway.

The decision comes just a few months after NHS England announced that it would be the first health system in the world to roll out Tecentriq SC to eligible patients, after receiving approval from the Medicines and Healthcare products Regulatory Agency.

NHS national director for cancer, professor Peter Johnson, said at the time of the August announcement: "Maintaining the best possible quality of life for cancer patients is vital, so the introduction of faster under-the-skin injections will make an important difference.”

https://www.pmlive.com/pharma_news/roches_subcutaneous_tecentriq_recommended_by_chmp_for_multiple_cancer_types_1503807