Halozyme Discloses That Bristol Myers Squibb Received Updated Action Date From U.S. FDA For Subcutaneous Nivolumab Co-Formulated With ENHANZE (Halozyme's Proprietary Recombinant Human Hyaluronidase Enzyme); The Updated Goal Date Is December 29, 2024
Halozyme Discloses That Bristol Myers Squibb Received Updated Action Date From U.S. FDA For Subcutaneous Nivolumab Co-Formulated With ENHANZE (Halozyme's Proprietary Recombinant Human Hyaluronidase Enzyme); The Updated Goal Date Is December 29, 2024
Halozyme announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. Food and Drug Administration for their Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with ENHANZE, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.
Halozyme宣布，美国食品药品监督管理局重新分配了Bristol Myers Squibb皮下配方的生物制剂许可证申请的《处方药使用者费用法》的目标日期 Opdivo （nivolumab）与Halozyme专有的重组人透明质酸酶enhanze共同配制而成 rhupH20，适用于所有先前批准的成人实体瘤 Opdivo 适应症为单一疗法，单一疗法完成后的维持治疗 Opdivo 加 耶尔沃伊 （ipilimumab）联合疗法，或与化疗或卡博赞替尼联合使用。更新的目标日期是2024年12月29日。
The application is based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab with ENHANZE to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.
该应用基于Checkmate-67T的结果，Checkmate-67T是尼沃鲁单抗皮下制剂的首个3期试验，旨在评估和证明与静脉注射配方相比，药代动力学、疗效和一致的安全性。如果获得批准，皮下注射nivolumab有可能成为第一种也是唯一一种皮下给药的PD-1抑制剂。