WASHINGTON - AstraZeneca (NASDAQ:AZN)'s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and given Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of muscle-invasive bladder cancer (MIBC). This designation is granted to drugs that could significantly improve the current standard of care, and the FDA's decision is expected in the second quarter of 2025.
Muscle-invasive bladder cancer affects about a quarter of bladder cancer patients, with approximately 117,000 treated annually with the current standard of care, which includes neoadjuvant chemotherapy and radical cystectomy. Despite these treatments, patients face high recurrence rates and poor prognosis.
The application is supported by results from the NIAGARA Phase III trial, which demonstrated a 32% reduction in the risk of disease progression, recurrence, surgery avoidance, or death when Imfinzi was combined with neoadjuvant chemotherapy before and after surgery, compared to chemotherapy and surgery alone. The trial also indicated a 25% reduction in the risk of death for patients treated with the Imfinzi regimen.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the urgent need for new treatments in this area and the potential of Imfinzi to alter the standard of care by delaying recurrence and extending survival.
Imfinzi was generally well tolerated in the trial, with no new safety concerns. It did not affect patients' ability to complete chemotherapy cycles or undergo surgery.
The drug is part of AstraZeneca's extensive oncology portfolio and is already approved for various cancer treatments, including non-small cell lung cancer, small cell lung cancer, and others. The company is committed to advancing cancer care and aims to redefine cancer treatment outcomes.
The information in this article is based on a press release statement from AstraZeneca.
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