Durvalumab has gained acceptance for the supplemental Biologics License Application and was granted Priority Review for a four-week, fixed-dose regimen for NSCLC and bladder cancer. 

Pending approval, the treatment would be administered intravenously every four weeks at a fixed dose of 1500 mg in unresectable stage III NSCLC following chemoradiation therapy and previously treated advanced bladder cancer, according to a press release from the manufacturer. 

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision is in the fourth quarter of 2020. 

The new dosing would be available as an alternative to the currently approved weight-based dosing of 10/mg/kg every two weeks.  

“The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimizing the risk of exposure to infection in the healthcare setting," Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said in the release. "This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications."

The sBLA was based on data from the Phase 3 CASPIAN trial in ES-SCLC which used the four-week, fixed-dose regimen during maintenance and several other clinical trials. 
 

By MD /alert Staff