The FDA has approved a 1,500mg fixed dose every four weeks as a new option for durvalumab as a treatment for unresectable stage III non-small cell lung cancer after chemoradiation and previously treated advanced bladder cancer.  

According to a release from the manufacturer, the approval was based on data from several clinical trials, including the phase III PACIFIC trial, which supported two-week, weight-based dosing, and the phase III CASPIAN trial which used a four-week, fixed dosing as a maintenance treatment.  

The FDA had previously granted the application priority review in August.  

"This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients," Victoria Villaflor, MD, from City of Hope Cancer Center, said in the release. "Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19."

A similar application is currently pending with other regulatory agencies, including the European Union, which had also granted accelerated assessment.

Durvalumab is currently approved as a treatment for unresectable, stage III NSCLC after chemoradiation therapy and for previously treated advanced bladder cancer patients.  

It is also being investigated as a treatment for other conditions, including SCLC, bladder cancer, and liver cancer.  


By Adam Hochron