Arsenic trioxide injection is approved for first-line treatment of specific leukemia
Arsenic trioxide injection is approved for first-line treatment of specific leukemia January 16, 2018 Source: WuXi PharmaTech Teva Pharmaceutical Industries, Inc. announced that the US FDA has approved the combination of Trisenox (arsenic trioxide) injection with tretinoin for the treatment of newly diagnosed low-risk promyelocytic leukemia (APL) patients characterized by the presence of t(15; 17 Translocation or PML/RARα gene expression. The approval is based on the FDA's priority review of published scientific literature data and a review of Teva's global arsenic trioxide safety database. APL is a life-threatening leukemia that can lead to uncontrolled bleeding that can cause death in hours or days if left untreated. In Europe, approximately 1,500 to 2,000 people are diagnosed with APL each year. Given its rarity, and because in most cases, low blood counts in the blood and low leukemia cells, the diagnosis can be very difficult. However, the rapid development of APL can lead to early death, a serious problem affecting up to 30% of patients. Therefore, rapid diagnosis and initiation of treatment are essential to avoid early death. Trisenox is a targeted drug that degrades the PML-RARα fusion protein. On March 5, 2002, the European Commission approved Trisenox's Marketing Authorization Application (MAA), which is valid throughout the European Union (EU). Trisenox received the FDA's marketing approval in 2000. The efficacy of this therapy was further confirmed in a non-inferiority phase 3 clinical study. Eligible patients were between 18 and 71 years of age, with newly diagnosed and genetically proven low or intermediate-risk APL (WBC diagnosis ≤ 103 x 109 / L) in adult patients. Overall, between 2007 and 2013, a total of 276 patients were randomized to receive either retinoic acid plus arsenic trioxide (ATRA-ATO) or retinoic acid plus chemotherapy (ATRA-CHT). In 263 patients with an evaluable induction response, 127 patients (100%) and 132 patients (97%) in each of the ATRA-ATO and ATRA-CHT groups achieved complete remission (CR) (P = 0.12). After a median follow-up of 40.6 months, the patient's event-free survival, cumulative recurrence time, and 50-month overall survival were 97.3% and 80%, 1.9%, and 13.9%, respectively, in the ATRA-ATO and ATRA-CHT groups, and 99.2% and 92.6% (P < 0.001, P = 0.0013 and P = 0.0073, respectively). Paul Rittman, senior vice president and general manager of Teva Oncology, said: "Today's expanded indication for Trisenox is Teva's commitment to advancing cancer treatment. Now Trisenox is an FDA-approved patient for acute promyelocytic leukemia. First-line treatment plan." We congratulate this drug for its extended indications and hope that this chemotherapy-free therapy will successfully cure more patients with such malignant blood cancers. Reference materials: [1] Teva Announces US FDA Approval of TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia [2] Teva Receives Positive Opinion from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox® for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL) [3] Teva Pharmaceutical Industries' official website Ph Test,Ph Strips,Ph Test Strips,Ph Test Kit Changchun ZYF science and technology CO.,LTD , https://www.zyf-medical.com
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