Roche Reports Acceptance of sBLA from FDA for its Tecentriq (atezolizumab) + Abraxane (nab-paclitaxel) for 1L Metastatic Triple- Negative Breast Cancer (TNBC)
Shots:
- The filling is based on the results of P-III IMpassion130 study- assessing Tecentriq + Abraxane vs PBO + Abraxane in 902 patients with 1L unresectable LA/M TNBC in ratio (1:1)
- P-III IMpassion130 study results: mPFS (7.2 vs 5.5mos.); OS (25.0 vs 15.5mos.); no new safety signals- Presented at ESMO 2018. The expected FDA approval date for the combination therapy is 12 Mar- 2019
- Tecentriq is a mAb binds with PD-L1 while blocking interaction with PD-1 and B7.1 receptor. Roche has 7 ongoing P-III trials for Tecentriq & has also received PR from FDA and is also approved by EU & FDA for metastaic NSCLC mUC in > 80 countries
Ref: Roche | Image: Roche
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