Posted by Michael Wonder on 18 Jan 2019
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
17 January 2019 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application for Tecentriq (atezolizumab) in combination with Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer who do not have EGFR or ALK genomic tumour aberrations.
The FDA is expected to make a decision on approval by 2 September 2019.
This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous non-small cell lung cancer.
