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FDA Grants Roche’s Tecentriq In Combination With Abraxane Accelerated Approval For People With PD-L1-positive, Metastatic Triple-Negative Breast Cancer

(Roche) Mar 11, 2019 - Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.

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Debu Tripathy, MD (Posted: March 11, 2019)

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This is a notable step forward in breast cancer therapeutics. Making advances, especially in survival, using immunotherapy has been a holy grail despite the long-held belief that the immune system is important in breast cancer when in fact, early immunotherapy trials using checkpoint inhibitors have been disappointing. However, the IMpassion130 trial is clearly positive - testing the addition of the anti PD-L1 antibody atezolizumab to nab-paclitaxel as first line therapy for PD-L1+ (in immune cells) triple negative breast cancer (TNBC). The indication does not specify line of therapy, but does specify the chemotherapy partner and need for PD-L1 testing. There will be a quick succession of results from additional trials - importantly, the KEYNOTE-355 trial testing the addition of pembrolizumab to one of three chemotherapy regimens also in the first line for TNBC is expected to report results later this year. Numerous randomized trials are ongoing (some preliminary already reported) in the neoadjuvant and adjuvant settings for all subsets of breast cancer. So expect an avalanche of data, but most importantly, more options for our patients that will hopefully make differences in survival and with some very long term responses.

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