AstraZeneca plc's (NASDAQ:AZN) cancer drug, Imfinzi (durvalumab), in conjunction with standard chemotherapy, has now received endorsement from the U.S. authorities for treating certain severe forms of endometrial cancer.
The U.S. Food and Drug Administration's (FDA) approval is specifically for adults with primary, advanced, or recurrent endometrial cancer that shows mismatch repair deficiency (dMMR).
The decision stems from the compelling evidence provided by the DUO-E Phase III trial, which has been documented in the Journal of Clinical Oncology.
In the clinical study, patients treated with Imfinzi in addition to the chemotherapy drugs carboplatin and paclitaxel, followed by a maintenance dose of Imfinzi alone, showed a 58% reduction in the risk of disease progression or death.
This combination demonstrated significant efficacy compared to chemotherapy alone, offering a new beacon of hope for those affected by the challenging condition.
According to Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center and principal investigator of the trial, "With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care."
Endometrial cancer, the fourth most prevalent cancer among U.S. women, led to almost 12,000 deaths in 2022.
Despite high survival rates at early stages, advanced cases remain difficult to treat, underscoring the need for effective therapies.
The safety profile of the Imfinzi and chemotherapy regimen aligns well with previous findings, showing manageability and tolerability within expected norms, and continues to be evaluated in ongoing trials including a combination of Imfinzi and Lynparza (olaparib).
AstraZeneca aims to increase its total revenue to $80 billion by 2030, a significant rise from $45.8 billion in 2023, through expansion in its oncology, biopharmaceuticals, and rare disease portfolios.
Price Action: AZN shares are down 0.82% at $78.94 during the premarket session at last check Monday.
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