Why Is Cancer-Focused Verastem Oncology Stock Trading Higher On Tuesday?
Why Is Cancer-Focused Verastem Oncology Stock Trading Higher On Tuesday?
In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.On Monday, the FDA accepted for review the New Drug Application under the accelerated approval pathway for Verastem Oncology's (NASDAQ:VSTM) avutometinib.
週一，FDA接受了Verastem Oncology（納斯達克：VSTM）關於avutometinib的新藥申請，進入加速審批程序。
The company seeks approval of avutometinib in combination with defactinib for adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who received at least one prior systemic therapy and have a KRAS mutation.
該公司尋求批准avutometinib與defactinib聯合用於接受過至少一種系統治療且具有KRAS突變的複發性低級別漿液性卵巢癌（LGSOC）成人患者。
The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act action date of June 30, 2025.
該新藥申請於2024年10月完成，已獲得優先審查，處方藥用戶費用法（PDUFA）行動日期爲2025年6月30日。
In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
此外，FDA表示目前沒有計劃召開諮詢委員會會議討論該申請。
The filing was based on a primary Phase 2 RAMP 201 clinical trial analysis.
該文件基於一項主要的第二期RAMP 201臨牀試驗分析。
The results were presented in an oral presentation at the International Gynecologic Cancer Society Annual Global Meeting in October 2024 and demonstrated that the combination of avutometinib plus defactinib resulted in a substantial overall response rate confirmed by a blinded independent central review, with responses that were typically durable, and that the combination was generally well-tolerated in patients with recurrent KRAS mutant LGSOC.
結果在2024年10月的國際婦科癌症學會年全球會議上進行了口頭報告，表明avutometinib與defactinib的組合在進行盲法獨立中心審查時，確實達到了顯著的總體反應率，反應通常具有持久性，並且該組合在複發性KRAS突變LGSOC患者中總體耐受性良好。
The NDA also includes supportive data from the FRAME Phase 1 trial, the first study conducted with the combination therapy in recurrent LGSOC.
該新藥申請還包括來自FRAME I期試驗的支持數據，這是針對複發性LGSOC的首個聯合治療研究。
The company is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status for RAMP 301, an international Phase 3 trial.
該公司目前正在招募無論KRAS突變狀態的複發性LGSOC患者，參與RAMP 301國際三期試驗。
The trial will serve as a confirmatory study for the initial indication and has the potential to support an expanded indication regardless of KRAS mutation status.
該試驗將作爲初步指示的確認研究，並有潛力支持擴展指示，無論KRAS突變狀態如何。
In May, Verastem Oncology revealed initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel as a first-line treatment for patients with metastatic pancreatic cancer.
在5月，Verastem腫瘤學揭示了正在進行的RAMP 205 1/2期試驗的初步中期安全性和有效性結果，該試驗評估了avutometinib與defactinib聯合使用吉西他濱和納米白蛋白紫杉醇，作爲轉移性胰腺癌患者的一線治療。
Price Action: VSTM stock is up 26.4% at $4.64 at last check Tuesday.
價格動態：VSTm股票在週二最後檢查時上漲26.4%，報4.64美元。
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Photo: Shutterstock
Photo: Shutterstock
譯文內容由第三人軟體翻譯。