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.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
阿斯利康公司(納斯達克股票代碼:AZN)的抗癌藥物Imfinzi(durvalumab)與標準化療相結合,現已獲得美國當局的批准,用於治療某些嚴重形式的子宮內膜癌。
美國食品藥品監督管理局 (FDA) 的批准專門適用於患有原發性、晚期或複發性子宮內膜癌且表現出錯配修復缺陷 (dmMR) 的成年人。
該決定源於DUO-E III期試驗提供的令人信服的證據,該試驗已記錄在《臨床腫瘤學雜誌》上。
在臨床研究中,除了化療藥物卡鉑和紫杉醇外,接受Imfinzi治療的患者,再單獨服用維持劑量的Imfinzi,疾病進展或死亡的風險降低了58%。
與單獨的化療相比,這種組合顯示出顯著的療效,爲受這種艱難疾病影響的人們提供了新的希望燈塔。
德克薩斯大學安德森癌症中心婦科腫瘤學和生殖醫學教授、該試驗首席研究員香農·威斯汀表示:“預計未來幾十年子宮內膜癌的發病率和死亡率將繼續大幅增加,因此我們比以往任何時候都更加重要的是儘早爲患者提供新的治療選擇。”
子宮內膜癌是美國女性中第四大流行的癌症,在2022年導致近12,000人死亡。
儘管早期存活率很高,但晚期病例仍然難以治療,這凸顯了對有效療法的需求。
Imfinzi和化療方案的安全性與先前的發現非常一致,顯示出可控性和耐受性在預期範圍內,並且在包括Imfinzi和Lynparza(奧拉帕里布)組合在內的正在進行的試驗中將繼續接受評估。
阿斯利康的目標是通過擴大其腫瘤學、生物製藥和罕見病產品組合,到2030年將其總收入從2023年的458億美元大幅增加到800億美元。
價格走勢:週一最後一次盤前交易中,AZN股價下跌0.82%,至78.94美元。
免責聲明:此內容部分是在人工智能工具的幫助下製作的,並由Benzinga的編輯審閱和發佈。