FDA approves new dosing option for AZ’s Imfinzi

The US Food and Drug Administration (FDA) has approved AstraZeneca’s (AZ) checkpoint inhibitor Imfinzi for an additional dosing option.

Imfinzi (durvalumab) has been approved for a 1,500mg 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 bladder cancer.

The FDA approved Imfinzi for this new dosing option after considering data from a number of clinical trials, including the PACIFIC phase III trial which supported the new dosing in NSCLC.

The new fixed-dosing option is also being considered under regulatory review in a number of other countries, including the EU where the new dosing option was granted an accelerated assessment.

“The approval of this new dosing option across indications reflects our ongoing commitment to improve the patient experience and ensure continuity of care - a priority at all times, but especially during the pandemic,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“Cancer won’t wait, and it is our job to provide patients with treatment options that acknowledge the challenges the pandemic poses to cancer care, enabling them to visit their physician when truly needed and avoid preventable exposure to healthcare-associated infections,” he added.