Roche Gains Further Approval by EC for Tecentriq Indications

EC has granted marketing authorization approval to Roche for Tecentriq (atezolizumab), in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer.

The European Commission has granted marketing authorization approval to Roche for Tecentriq (atezolizumab),in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer.

Approval in this indication was granted as a result of outcomes from a Phase III study, demonstrating an improvement in length of life when compared with chemotherapy alone. Additionally, the combination treatment was found to significantly reduce the risk of disease worsening or death when compared with chemotherapy alone. The safety profile for Tecentriq and chemotherapy combination treatment was found to be consistent with the safety profile of Tecentriq.

“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development, in a Sep. 6, 2019 press release. “The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care-an advance that, until now, has been difficult to achieve due to the refractory nature of this disease.”

Tecentriq is now approved in the United States, European Union, and other countries around the world, as a treatment (either alone or in combination) for various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.

Source: Roche