Roche Receives European Commission Approval of Tecentriq SC With Halozyme's ENHANZE Representing The EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy For Multiple Cancer Types
Roche Receives European Commission Approval of Tecentriq SC With Halozyme's ENHANZE Representing The EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy For Multiple Cancer Types
Reduces treatment time by approximately 80% compared to standard intravenous (IV) infusion
與標準靜脈 (IV) 輸注相比，治療時間縮短了大約 80%
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to IV infusion and is preferred by patients and healthcare practitioners1 - 6.
皮下（SC）注射有可能爲靜脈輸注提供更快、更便捷的替代方案，是患者和醫療保健從業人員的首選1-6。
"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems," said Dr. Helen Torley, president and chief executive officer of Halozyme.
Halozyme總裁兼首席執行官海倫·託利博士表示：“作爲歐洲第一種皮下PD-（L）1癌症免疫療法，Tecentriq SC可以提供一種新的治療選擇，可以增強患者和護理人員的治療體驗，同時爲受限的醫療系統騰出資源。”
The EC approval follows pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation6.
歐盟委員會的批准遵循了IB/III期imsCin001研究的關鍵數據，該研究顯示，皮下給藥時，血液中的Tecentriq水平相當，安全性和有效性與靜脈注射配方一致。該研究發現，90％的醫療保健專業人員認爲SC配方易於服用，75％的醫療保健專業人員表示，與靜脈注射配方相比，它可以爲醫療團隊節省時間6。