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FDA Accepts Roche’s Supplemental Biologics License Application For Tecentriq Plus Chemotherapy (Abraxane And Carboplatin) For The Initial Treatment Of Metastatic Non-squamous Non-small Cell Lung Cancer

(Roche) Jan 17, 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. The FDA is expected to make a decision on approval by 2 September 2019. “We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”

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H. Jack West, MD (Posted: January 17, 2019)

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This application is based on the results of the IMpower130 trial of first line carbo/nab-paclitaxel with or without atezolizumab in patients with advanced non-squamous NSCLC (disclosure: I am an author on the abstract presented thus far and future publication). The trial is positive for not just an improvement in progression-free survival but also overall survival, which is an achievement. However, I see the limiting factor being that the true comparator in this setting today isn't chemotherapy alone, as was in the trial, but the KEYNOTE-189 combination of carbo/pemetrexed/pembrolizumab in the same setting. Though there can always be an occasion for which an alternative to the carbo/pemetrexed backbone is needed, this chemo regimen and the KEYNOTE-189 combination in general is one that the vast majority of lung cancer specialists and general oncologists alike are very happy to use as their preferred regimen. This will likely relegate the IMpower130 combination being considered here to very, very limited use. There is simply little to no incremental benefit it offers over KEYNOTE-189 in the same setting.

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