Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Breyanzi® (lisocabtagene maraleucel) under Priority Review. This application aims to expand the use of Breyanzi as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. If approved, Breyanzi would become the first and only CAR T cell therapy available for MZL, addressing a high unmet medical need. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025, for the review completion. This milestone reflects BMS's ongoing efforts to enhance access to innovative cell therapies for cancer patients.
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。