FDA delays decision on Roche's filing for Tecentriq, Avastin, chemotherapy combination in lung cancer

Roche said Thursday that the FDA extended its review of a filing seeking approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small-cell lung cancer (NSCLC) by three months. The company noted that the extension will give the agency time to review additional information requested in support of the application, with a new target review date of December 5.

The filing, which had been granted priority review in May, is based on results of the Phase III IMpower150 trial. Roche reported earlier this year that the study met its co-primary endpoint of overall survival, with the combination of Tecentriq and Avastin plus chemotherapy significantly extending survival compared with Avastin plus chemotherapy.

Previous data from the trial showed that the combination of Tecentriq and Avastin plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy. Results demonstrated that patients who received Tecentriq and Avastin plus chemotherapy had a 38 percent reduced risk of their disease worsening or death compared with those who received Avastin plus chemotherapy, with respective median progression-free survival of 8.3 months and 6.8 months.

Tecentriq is currently approved in the EU, US and over 70 countries for people with previously treated metastatic NSCLC, as well as for certain types of untreated or previously treated metastatic urothelial carcinoma. Roche is also evaluating the PD-L1 inhibitor alone or in combination with other medicines in eight Phase III lung cancer studies.

For related analysis, see ViewPoints: Roche's regulatory setback for Tecentriq - delaying inevitable disappointment?

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