Roche Holding AG said the U.S. Food and Drug Administration accepted the supplemental biologics license application for a Tecentriq combination to treat a type of lung cancer.
The Swiss drugmaker is seeking the approval of Tecentriq, or atezolizumab, in combination with chemotherapy drugs Abraxane and carboplatin for the initial treatment of patients with non-squamous non-small cell lung cancer, or NSCLC, who do not show mutations on the EGFR or ALK genes and whose cancer has spread to new areas of the body.
Results from the phase 3 study known as IMpower130 showed the Tecentriq combo helped extend the lives of NSCLC patients while keeping the disease at bay, meeting the trial's main goals.
The FDA is anticipated to decide on the application by Sept. 2. The agency recently approved Tecentriq in combination with Avastin and chemotherapy drugs paclitaxel and carboplatin for the aforementioned indication.