AstraZeneca gains priority review from FDA for Imfinzi fixed dose regime
AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi.
AZ have stated that if the new regimen is approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. This includes unresectable, stage three non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.
Currently, Imfinizi is administered to patients via weight-based dosing of 10mg/kg every two weeks. The four-week Imfinzi dosing regimen is already approved for use in extensive-stage small cell lung cancer (ES-SCLC), following positive results from the phase 3 CASPIAN trial in ES-SCLC which used the fixed-dose schedule.
“The new less-frequent dosing option for NSCLC 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 vice president of AZ’s oncology business unit.
“This takes on particular urgency during the current pandemic, as doctors care for patients who are at high risk of COVID-19 complications,” he added.
In 2019 Imfinzi added almost $1.5bn to AZ’s top-line, mainly due to the drug’s use as a maintenance therapy in NSCLC patients. The new dosing schedule, which involves fewer trips to the hospital and a flexible treatment option, could help to grow the drug’s position in the highly competitive NSCLC market.