Current Edition

Priority review for Imfinzi’s less-frequent dosing regimen

AstraZeneca’s Imfinzi (durvalumab) has been granted a priority review in the US for a new four-week, fixed-dose regimen for treatment of non-small cell lung cancer (NSCLC) and bladder cancer.

If approved, the drug could be administered intravenously every four weeks at a fixed dose of 1500mg in unresectable Stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer, consistent with the approved dosing in extensive-stage small cell lung cancer (ES-SCLC).

The new dosing would be available as an alternative to the approved weight-based dosing of 10mg/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 minimising the risk of exposure to infection in the healthcare setting,” said Dave Fredrickson, executive VP, AZ’ Oncology Business Unit.

“This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications. We are working with health authorities in the US and other countries to bring the option of four-week, fixed dosing for Imfinzi to patients around the world as soon as we can.”

Imfinzi was also recently recommended for marketing authorisation in the EU for this indication. In the US, a decision is expected sometime during the fourth quarter.