AstraZeneca’s Imfinzi has been accepted and granted priority review by the US Food & Drug Administration (FDA) for the treatment of limited-stage small cell lung cancer (LS-SCLC).
The FDA’s decision was prompted by the results of the Phase III ADRIATIC trial, which found durvalumab to provide significant improvements in overall survival (OS) and progression-free survival (PFS).
It was observed that Imfinzi could reduce the risk of death in patients by 24%, while also improving PFS by 7.4 months compared to placebo.
Priority review is offered to medicines that have the potential to offer significant improvements in patient outcomes compared to options currently available on the market.
This is generally owing to their improved safety, efficacy or their ability to enhance patient compliance.
The therapeutic was also granted Breakthrough Therapy Designation by the FDA, which accelerates the regulatory review process for novel medicines that could address a significant unmet need.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer. There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in forty years, and we look forward to working with the FDA to bring Imfinzi to patients as quickly as possible.”