Roche’s Tecentriq + Abraxane Receive FDA’s Accelerated Approval for mTNBC
Roche’s Rozlytrek (entrectinib) Receives MHLW’s Approval for NTRK Fusion-Positive Advanced Recurrent Solid Tumors in Adult and Pediatric Patients in Japan
Shots:
- 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
Click here to read full press release/ article | Ref: Roche | Image: Chemical Industry Digest