FDA: four-week dosing approved in all Imfinzi indications, reducing medical visits and improving patient convenience
Imfinzi ( Durvalumab ) has been approved in the US for an additional dosing option, a 1,500 mg fixed dose every four weeks, in the approved indications of unresectable stage III non-small cell lung cancer ( NSCLC ) after chemoradiation therapy ( CRT ) and previously treated advanced bladder cancer.
This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer ( ES-SCLC ) and will be available to patients weighing more than 30 kg as an alternative to the approved weight-based dosing of 10 mg/kg every two weeks.
The approval by the Food and Drug Administration ( FDA ) was based on data from several Imfinzi clinical trials, including the PACIFIC phase III trial which supported the two-week, weight-based dosing in unresectable stage III NSCLC, and the CASPIAN phase III trial which used four-week, fixed-dosing during maintenance treatment in ES-SCLC.
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.
Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.
Imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in the US, in the EU, in Japan, in China and in many other countries, based on the PACIFIC phase III trial.
Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.
Additionally, it is approved in the US, the EU, Japan and several other countries around the world for the treatment of ES-SCLC based on the CASPIAN phase III trial. ( Xagena )
Source: AstraZeneca, 2020