AstraZeneca PLC (LON:AZN) has announced that its Imfinzi cancer treatment has been approved in the US for an additional dosing option, a 1,500 milligrams (mg) fixed-dose every four weeks, in the approved indications.
The drug is already approved to treat unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.
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This new option will be available to patients weighing more than 30 kilograms (kg) as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.
The decision by the US Food and Drug Administration (FDA) was based on data from several Imfinzi clinical trials and follows the Priority Review granted in August, the FTSE 100 pharma company said.
The new four-week 1,500mg fixed-dosing option for Imfinzi is also under regulatory review in several other countries including in the EU, where the new dosing option was granted accelerated assessment.
Imfinzi is approved to treat unresectable, stage III NSCLC after chemotherapy in the US, EU, Japan, and China among other countries, and also for previously treated patients with advanced bladder cancer in the US and other countries.
The drug is also approved in the US, EU, Japan and other countries for extensive-stage small-cell lung cancer.
"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,” said Victoria Villaflor, Clinical Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, California in a statement.