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宣佈，美國食品藥品監督管理局重新分配了Bristol Myers Squibb皮下配方的生物製劑許可證申請的《處方藥使用者費用法》的目標日期 Opdivo （nivolumab）與Halozyme專有的重組人透明質酸酶enhanze共同配製而成 rhupH20，適用於所有先前批准的成人實體瘤 Opdivo 適應症爲單一療法，單一療法完成後的維持治療 Opdivo 加 耶爾沃伊 （ipilimumab）聯合療法，或與化療或卡博贊替尼聯合使用。更新的目標日期是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.
該應用基於Checkmate-67T的結果，Checkmate-67T是尼沃魯單抗皮下製劑的首個3期試驗，旨在評估和證明與靜脈注射配方相比，藥代動力學、療效和一致的安全性。如果獲得批准，皮下注射nivolumab有可能成爲第一種也是唯一一種皮下給藥的PD-1抑制劑。
譯文內容由第三人軟體翻譯。