Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer

Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient and time-saving alternative to traditional intravenous infusions.

Clinical Studies and Efficacy
Multiple global clinical studies have demonstrated that the subcutaneous preparation of trastuzumab is equivalent to the standard intravenous infusion in terms of efficacy and safety. The new dosage form not only reduces treatment costs but also significantly shortens treatment time, bringing greater convenience to breast cancer patients.

Advantages of Subcutaneous Injection
Herceptin was first approved in China in 2002 for use in HER2-positive early/metastatic breast cancer and HER2-positive metastatic gastric cancer. It was included in China’s National Reimbursement Drug List (NRDL) in July 2017. The traditional intravenous infusion dosage form requires patients to visit the hospital once every three weeks, with each dose taking 30 to 90 minutes. In contrast, the subcutaneous injection leverages hyaluronidase to temporarily reduce the viscosity of intercellular substances, promoting rapid diffusion and absorption of trastuzumab. This ready-to-use preparation can be completed in just 2-5 minutes. Additionally, the subcutaneous preparation is a fixed dose, eliminating the need to calculate the dose based on each patient’s weight, which greatly facilitates both patients and medical staff.

Future Outlook
The approval of the subcutaneous injection form of Herceptin underscores Roche’s commitment to improving patient outcomes and enhancing treatment accessibility. By offering a more convenient and efficient treatment option, Roche aims to address the significant unmet needs of patients with HER2-positive breast cancer in China.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry