FDA accepts sBLA for Tecentriq plus nab-paclitaxel for first line treatment of triple negative breast cancer.- Genentech /Roche

Genentech announced the FDA has accepted the company�s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by March 12, 2019. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The sBLA is based on data from the Phase III IMpassion 130 study, which was presented at the European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine in October 2018. Results demonstrate Tecentriq plus nab-paclitaxel as an initial (first-line) treatment for unresectable locally advanced or metastatic TNBC significantly reduced the risk of disease worsening or death (progression-free survival, compared with nab-paclitaxel alone in all randomized patients. Follow-up will continue until the next planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

See-"Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer"- Peter Schmid, M.D., Ph.D., Sylvia Adams, M.D., Hope S. Rugo, M.D., Andreas Schneeweiss, M.D., et al., for the IMpassion130 Trial Investigators- October 20, 2018.DOI: 10.1056/NEJMoa1809615.