Roche's Genentech unit announced Monday that the FDA granted priority review to its marketing application for the PD-L1 inhibitor Tecentriq (atezolizumab), in combination with Avastin (bevacizumab) plus standard chemotherapy, for the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC). The US regulator is expected to render its decision on the filing by September 5.
The company said the submission is based on results of the Phase III IMpower150 trial of 1202 patients with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. Recently released data from the study showed that the combination of Tecentriq with Avastin and chemotherapy significantly prolonged overall survival and progression-free survival, versus Avastin and chemotherapy alone.
Sandra Horning, head of global product development and chief medical officer, remarked "our Phase III results showed Tecentriq in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous [NSCLC]." She added "we are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible."
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Earlier this year, Roche also unveiled Phase III data from the IMpower131 trial demonstrating that first-line treatment with Tecentriq plus chemotherapy reduced the risk of disease progression or death in patients with advanced squamous NSCLC. For related analysis, see ViewPoints: Roche looks to side-step rivals in lung cancer race but the jury is still out.
Tecentriq is already approved for patients with metastatic NSCLC 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. The drug is also cleared in the US for locally advanced or metastatic urothelial carcinoma and to treat locally advanced or metastatic urothelial carcinoma in patients not eligible for cisplatin chemotherapy.
Last month, Roche disclosed that first-quarter sales of Tecentriq jumped 29 percent year-over-year to 139 million Swiss francs ($138.4 million), missing expectations of 154 million francs ($153.3 million).
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