FDA Grants Priority Review to New Fixed-Dose of Imfinzi in NSCLC and Bladder Cancer

The Food and Drug Administration (FDA) granted a priority review designation to a new four-week, fixed-dose regimen of Imfinzi (durvalumab) for the treatment of patients with non-small cell lung cancer (NSCLC) and bladder cancer, according to the agent’s manufacturer – AstraZeneca.

The designation is based on data from multiple clinical trials, including the phase 3 CASPIAN trial which showed that the new fixed-dose regimen of Imfinzi demonstrated a sustained overall survival benefit in patients with extensive-stage small cell lung cancer.

If approved by the FDA, the treatment could be administered intravenously every four weeks at a fixed dose of 1,500 milligrams (mg) in patients with stage 3 NSCLC after they received chemoradiation treatment, as well as in patients with previously treated bladder cancer, according to a company-issued press release.

“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 minimizing the risk of exposure to infection in the health care setting,” said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business Unit, in the release. “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 U.S. and other countries to bring the option of four-week, fixed dosing for Imfinzi to patients around the world as soon as we can.”