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Roche's Tecentriq + Abraxane Receive FDA's Accelerated Approval for mTNBC

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Roche's Tecentriq + Abraxane Receive FDA's Accelerated Approval for mTNBC

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  • The accelerated approval is based on P-III IMpassion130 study assessing Tecentriq + Abraxane vs PBO + Abraxane in 902 patients with PD-L1+ advanced or mTNBC with no prior therapy in ratio 1:1
  • The P-III IMpassion130 study results: mPFS (7.4mos. vs 4.8 mos.); OS (43%); no new safety signals
  • Tecentriq + Abraxane is a combination of mAb targeting PD-L1 protein & chemotherapeutic agent. Tecentriq is approved in EU- the US and other 85 countries for NSCLC & mUC

Ref: Roche | Image: Roche

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