FDA grants priority review to fixed-dose Imfinzi for lung, bladder cancer
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The FDA granted priority review to durvalumab for administration in a 4-week, fixed dose regimen for the treatment of patients with non-small cell lung cancer and bladder cancer, according to a manufacturer-issued press release.
If approved, this indication of durvalumab (Imfinzi, AstraZeneca), an anti-PD-L1 agent, would provide an alternative treatment schedule to the approved weight-based dosing of 10 mg/kg every 2 weeks. The new schedule allows for IV treatment every 4 weeks at a fixed dose of 1,500 mg for patients with unresectable stage III NSCLC after chemoradiation or with previously treated advanced bladder cancer. Several clinical trials, including the phase 3 CASPIAN trial in extensive-stage small cell lung cancer, provided data supporting this regimen.
“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 [for] exposure to infection in the health care setting,” Dave Fredrickson, executive vice president of the AstraZeneca Oncology Business Unit, said in the release. “This takes on particular urgency during the current pandemic, as doctors care for patients at high risk [for] COVID-19 complications. We are working with health authorities in the U.S. and other countries to bring the option of 4-week, fixed dosing for Imfinzi to patients around the world as soon as we can.”
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