Roche's Genentech unit on Friday announced that the FDA granted accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy for use in adults with PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Sandra Horning, chief medical officer and head of global product development at Roche, commented that "this Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease." 

Approval was supported by data from the placebo-controlled Phase III IMpassion130 study of 902 patients with unresectable, locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. Among the 369 patients in the PD-L1-positive cohort, median progression-free survival was 7.4 months for patients treated with Tecentriq plus Celgene's Abraxane (nab-paclitaxel), versus 4.8 months for those on Abraxane alone, reflecting a significant 40-percent reduced risk of disease worsening or death.

Roche said results for overall survival (OS), the other co-primary endpoint in IMpassion130, were immature with 43 percent of events in all randomised patients, but that further data would be shared with the FDA and presented at an upcoming medical meeting. The company reported results from the trial last October, saying an interim analysis had shown there was no significant difference in median OS for the intent-to-treat study population. However, when looking at the PD-L1-positive cohort, Tecentriq-treated patients had achieved "clinically meaningful 9.5-month OS improvement," Roche noted at the time.

The FDA evaluated Tecentriq under a priority review for use in the PD-L1-positive, triple-negative breast cancer indication. The drug is also approved in the US for use in urothelial carcinoma and non-small-cell lung cancer (NSCLC).

Separately on Friday, Roche announced that Tecentriq was approved by European regulators in combination with Avastin (bevacizumab) and chemotherapy for the first-line treatment of adults with metastatic non-squamous NSCLC. Tecentriq sales in the quarter ended December 31 surged 88 percent year-on-year to 248 million Swiss francs ($246 million), and totalled 772 million francs ($766 million) for all of 2018.

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