Roche Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Roche.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, May 2, 2018 to Tuesday, May 8, 2018.
FDA Grants Priority Review to Roche’s Cancer Drug Tecentriq for New Use
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental biologics license application (sBLA) and granted priority review for Tecentriq (atezolizumab), in combination with Roche’s Avastin (bevacizumab), paclitaxel, and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).
The FDA is expected to make a decision on approval by September 5, 2018. 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.
Tecentriq is currently approved by the FDA to treat patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy and who have progressed on an appropriate FDA-approved targeted therapy if their tumor has anaplastic lymphoma kinase and epidermal growth factor receptor mutations.