Halozyme and Bristol Myers Squibb Secure FDA Nod for Opdivo Qvantig
Halozyme and Bristol Myers Squibb Secure FDA Nod for Opdivo Qvantig
Halozyme Therapeutics, Inc. (NASDAQ:HALO) (Halozyme) today announced that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme's ENHANZE drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor.
奧洛茲美醫療公司（納斯達克：HALO）（Halozyme）今天宣佈，百時美施貴寶獲得了美國食品和藥物管理局（FDA）對Opdivo Qvantig（nivolumab和hyaluronidase-nvhy）的批准，該藥物與奧洛茲美醫療的ENHANZE藥物輸送科技共同配製，可用於大部分之前已獲批准的成人實體腫瘤靜脈（IV）Opdivo適應症的單藥治療、在完成Opdivo加Yervoy（ipilimumab）聯合治療後的單藥維持治療，或與化療或cabozantinib聯合使用。Opdivo Qvantig是首個也是唯一一個皮下注射的PD-1抑制劑。
The subcutaneous administration of Opdivo Qvantig is faster, with a three- to five-minute administration time compared to 30 minutes for IV Opdivo.* Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, may reduce steps required for preparation and time needed for administration.
Opdivo Qvantig的皮下注射更快，注射時間爲三到五分鐘，而IV Opdivo的注射時間爲30分鐘。*皮下注射可能提供靈活性，在最適合患者及其提供者的地方進行治療，可能減少所需的準備步驟和注射時間。
譯文內容由第三人軟體翻譯。
