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AZ scores FDA priority review for new Imfinzi fixed-dose regimen

Four-week dosing schedule offers new flexibility for patients

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.

According to AZ, if the new regimen is approved, Imfinzi (durvalumab) 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.

Despite ongoing disruption caused by the COVID-19 pandemic, AZ has escaped the brunt of the impact and has posted modest growth so far this year.

The British drugmaker’s oncology portfolio is particularly crucial to this growth, with total revenue for its oncology medicines increasing by 28% for the half year to $5.32bn.

Last year, 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.

Merck & Co’s checkpoint inhibitor Keytruda (pembrolizumab) currently holds much of the NSCLC market, although the drug failed to show benefit in SCLC when added to chemotherapy.

The disappointing results in SCLC marred an otherwise dominant position in lung cancer for Merck’s drug, which has become a new standard of care for newly-diagnosed NSCLC patients.

Article by
Lucy Parsons

18th August 2020

From: Regulatory



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