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www.fdanews.com/articles/208855-roches-subcutaneous-version-of-tecentriq-showed-positive-phase-3-results

Roche’s Subcutaneous Version of Tecentriq Showed Positive Phase 3 Results

August 3, 2022

The subcutaneous version of Roche’s blockbuster cancer drug Tecentriq (atezolizumab) met the primary endpoints in a phase 3 study, the company said.

The subcutaneous formulation demonstrated non-inferiority compared with the intravenous infusion method for cancer immunotherapy-naïve participants with locally advanced or metastatic nonsmall-cell lung cancer for whom prior platinum therapy has failed.

Benefits of the subcutaneous version include reduced pain and discomfort, ease of administration and shorter duration of treatment, the company said.

Roche will use the data to support submissions to the FDA and the EMA for regulatory approval for the indication.

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