(Alliance News) - AstraZeneca PLC on Tuesday said its Imfinzi has been accepted for its supplemental biologics license application by the Food & Drug Administration and has been granted priority review for a less-frequent dose regiment for the treatment of non-small cell lung cancer and bladder cancer.
The biopharmaceutical company's Imfinzi could be administered intravenously every four weeks if it is approved. This would effectively half the number of medical visits patients would have to undergo.
Imfinzi is a human anitbody which counters a tumour's immune-evading abilities.
Imfinzi would be administered at a fixed dose for stage 3 non-small-cell lung carcinoma after chemoradiation therapy and previously treated advanced bladder cancer.
The FDA only grants priority review status to medicines which offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
The supplemental biologics license application was based on data from numerous Imfinzi clinical trials.
Dave Fredrickson, head of the Oncology Business Unit at Astra, said: "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 minimising the risk of exposure to infection in the healthcare setting. This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of Covid-19 complications."
AstraZeneca shares were down 0.3% at 8,553.00 pence each on Tuesday morning in London.
By Greg Roxburgh; firstname.lastname@example.org
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