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Roche's breast cancer drug pertuzumab was approved for marketing
Recently, the State Drug Administration approved the import registration application of Pertuzumab Injection (English name: Pertuzumab Injection), combined with trastuzumab and chemotherapy for human epidermis with high risk of recurrence. Adjuvant therapy for growth factor receptor 2 (HER2)-positive early breast cancer patients.
Breast cancer is the most common malignant tumor in women . After HER2-positive early breast cancer patients receive Herceptin combined with chemotherapy, about one-fourth of patients still have recurrence or death after 10-11 years, and high-risk early breast cancer patients have a higher rate of recurrence or death. Pertuzumab injection is a novel anti-HER2 drug developed by Roche that produces anti-HER2 effects by inhibiting HER2 heterologous and homodimeric dimers. Global key phase III adjuvant therapy studies show that pertuzumab in combination with trastuzumab and chemotherapy is used in patients with HER2-positive early breast cancer who have a high risk of relapse compared with current standard treatment with trastuzumab Treatment significantly improved the survival of patients without invasive disease, and the adverse reactions were controllable. In view of the obvious clinical benefit/risk advantage of this product, on December 17, the State Drug Administration approved the import registration of this product, combined with trastuzumab and chemotherapy for the adjuvant of HER2-positive early breast cancer patients with high risk of recurrence. treatment.
In accordance with the spirit of the Central Committee of the Communist Party of China and the State Council on deepening the reform of the drug review and approval system, the State Drug Administration encourages domestic and foreign simultaneous research and development and registration of innovative drugs, and the clinical trial data obtained through international multi-center clinical trials is in compliance with drug registration. Relevant requirements, direct approval of the listing, so that our patients can use the innovative drugs with precise curative effect and controllable safety risks as soon as possible to better meet the needs of the public.