AstraZenecas Imfinzi gets U.S. fixed-dose use OK – MarketWatch
AstraZeneca PLC said Friday that Imfinzi–used in the treatment of certain cancers–has been approved by the U.S. Food and Drug Administration for less frequent, fixed-dose use.
The British pharmaceuticals giant said the 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.
Imfinzi has been approved for a dosing option of 1,500 milligram every four weeks, in the approved indications of unresectable stage III non-small cell lung cancer after chemoradiation therapy, and previously treated advanced bladder cancer.
The company said this also limits potential exposure to infection in the healthcare environment for a population especially vulnerable to complications from Covid-19.
AstraZeneca added that the fixed-dosing option was under regulatory review in several other countries, including in the EU.