Bristol-Myers Squibb (BMY) said Monday the US Food and Drug Administration has accepted its supplemental biologics license application for colorectal drug Opdivo plus Yervoy as a potential first-line treatment option for adult and pediatric patients.
The application is for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
The FDA granted the application a priority review status with a goal date of June 23, under the Prescription Drug User Fee Act.
The application was based on results from the three-arm phase 3 CheckMate -8HW study demonstrating that Opdivo plus Yervoy met the dual primary endpoints of progression-free survival, the company said.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。