20th Oct 2020 08:19
(Alliance News) - AstraZeneca PLC on Tuesday said Tagrisso has received acceptance for its supplemental New Drug Application and has been granted priority review in the US for the treatment of patients with early-stage non-small cell lung cancer.
The US Food & Drug Administration grants priority review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. A priority review designation means that the regulator plans to take action on an application within 6 months of acceptance compared to 10 months under standard review.
In this case, the FDA has set a date for a regulatory decision in the first quarter of 2021.
AstraZeneca explained that, while up to 30% of all patients with non-small cell lung cancer may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease. It noted that nearly half of patients diagnosed in Stage IB and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
AstraZeneca said the supplemental New Drug Application was based on results from the ADAURA Phase III trial which demonstrated that Tagrisso reduced the risk of disease recurrence or death by 80%.
AstraZeneca shares were trading 0.4% higher at 8,143.00 pence each early Tuesday morning in London.
By Ife Taiwo; [email protected]
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