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.
Related news and insights
Zai Lab Limited and its partner Entasis Therapeutics Holdings Inc. announced topline results from the ATTACK trial, a global Phase III registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii.
Atea Pharmaceuticals, Inc. reported that the global Phase II MOONSONG trial evaluating AT 527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 compared to placebo in the overall study population, of which approximately two thirds of patients were low-risk with mild symptoms.