FDA Grants Priority Review for New Durvalumab Dosing Regimen in NSCLC
Posted: Wednesday, August 19, 2020
On August 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for a new 4-week, fixed-dose of 1,500 mg for the PD-L1 antibody durvalumab in the treatment of unresectable stage III non–small cell lung cancer (NSCLC) after chemotherapy. The Priority Review will also assess this new fixed-dose regimen for previously treated advanced bladder cancer.
Based on the phase III PACIFIC trial results, durvalumab is already approved in the curative-intent setting for the treatment of unresectable, stage III NSCLC after chemotherapy in the United States, Japan, China, across the European Union, and in many other countries. If approved, the new dosing regimen will be available as an alternative to the approved weight-based dosing of 10 mg/kg every 2 weeks. The sBLA was based on data from several durvalumab clinical trials, including results from the phase III CASPIAN trial in extensive-stage small cell lung cancer, which used the 4-week, fixed-dose regimen during maintenance therapy.
As part of a broad development program, durvalumab is also being tested as a monotherapy and in combination with tremelimumab for treatment of patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer, and other solid tumors.