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Tecentriq + Abraxane for TNBC gets accelerated approval

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Approval is based on data from the phase three IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40 percent compared with nab-paclitaxel alone (median PFS=7.4 versus 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. Overall survival results were immature with 43 percent of events in all randomized patients, and further data will be shared with the FDA and presented at an upcoming medical meeting, the company reports.

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