Roche's marketing application for Tecentriq in small-cell lung cancer gets FDA priority review

Roche said Wednesday that the FDA granted priority review to a marketing application seeking approval of Tecentriq (atezolizumab), in combination with chemotherapy, for the initial treatment of people with extensive-stage small-cell lung cancer (SCLC). The agency is expected to make a decision on clearance of the PD-L1 inhibitor in this indication by March 18, 2019.

The submission is based on data from the Phase III IMpower133 study, with results presented in September at the World Conference on Lung Cancer (WCLC) showing that patients given Tecentriq plus standard chemotherapy lived significantly longer compared with chemotherapy alone, at 12.3 months versus 10.3 months, respectively. The results also showed that the combination significantly reduced the risk of disease worsening or death, with Tecentriq-treated patients achieving progression-free survival of 5.2 months, versus 4.3 months for those on chemotherapy alone.

Further results showed that the one-year overall survival rate for the Tecentriq arm was 51.7 percent, compared to 38.2 percent for chemotherapy alone. "It's been more than 20 years since there has been a new initial treatment option for extensive-stage small-cell lung cancer that delivers a clinically meaningful survival benefit," remarked Sandra Horning, chief medical officer at Roche.

In the US, Tecentriq is currently approved to treat people with metastatic non-small-cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK or EGFR gene abnormalities. Last month, the agency granted priority review to a filing seeking approval of the therapy for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the PD-L1 protein, with a decision expected by March 12, 2019.

For related analysis, see ViewPoints: Two strikes and Opdivo may be out in SCLC.

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