Imfinzi (durvalumab) granted Priority Review and Breakthrough Therapy designation for patients with limited-stage small cell lung cancer in the US.- AstarZeneca
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy (cCRT), has been accepted and granted Priority Review in the US.
The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.
Imfinzi was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy and radiotherapy in LS-SCLC patients. The prognosis for LS-SCLC is particularly poor, as only 15-30% of these patients will be alive five years after diagnosis.
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