AstraZeneca gets US approval for additional Imfinzi dosing option
AstraZeneca announced on Friday that ‘Imfinzi’, or durvalumab, has been approved in the US for an additional dosing option - a 1,500mg fixed dose every four weeks in the approved indications of unresectable stage-3 non-small cell lung cancer after chemoradiation therapy, and previously-treated advanced bladder cancer.
The FTSE 100 pharmaceuticals giant said the new option was consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer, and would be available to patients weighing more than 30 kilograms as an alternative to the approved weight-based dosing of 10mg per kilogram every two weeks.
It said the approval by the Food and Drug Administration (FDA) was based on data from several Imfinzi clinical trials, including the ‘PACIFIC’ phase 3 trial, which supported the two-week weight-based dosing in unresectable stage 3 non-small cell lung cancer, and the ‘CASPIAN’ phase 3 trial which used four-week, fixed-dosing during maintenance treatment in extensive-stage small cell lung cancer.
The decision followed the priority review granted by the FDA in August.
“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 executive vice-president of AstraZeneca’s oncology business unit, Dave Fredrickson.
“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.”
AstraZeneca said the four-week 1,500mg fixed-dosing option for Imfinzi was also under regulatory review in a number of other jurisdictions, including in the EU, where the new dosing option was granted accelerated assessment.
Imfinzi is approved in the curative-intent setting of unresectable, stage-3 non-small cell lung cancer after chemoradiation therapy in the US, the EU, Japan, China and in a number of other countries, based on the ‘PACIFIC’ phase 3 trial.
It 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 a number of other countries for the treatment of extensive-stage small cell lung cancer based on the ‘CASPIAN’ phase 3 trial.
At 0829 GMT, shares in AstraZeneca were up 0.75% at 8,185.68p.