美国食品和药物管理局批准新型口服组合治疗未经治疗的CLL, FDA approves new oral combo for untreated CLL, showing better outcomes than chemo.

美国食品和药物管理局批准了VENCLEXTA (venetoclax) 和acalabrutinib (Calquence) 的口服组合,作为治疗以前未经治疗的慢性淋巴细胞白血病 (CLL) 的第一个固定的时间,全口服治疗. The FDA has approved the oral combination of VENCLEXTA (venetoclax) and acalabrutinib (Calquence) as the first fixed-duration, all-oral treatment for previously untreated chronic lymphocytic leukemia (CLL). 根据 " AMPLIFY " 第三阶段试验,该疗法比化疗减少了35%的疾病发展或死亡风险,没有达到中位无进展存活率,而标准护理为47.6个月。 Based on the Phase 3 AMPLIFY trial, the regimen reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy, with median progression-free survival not reached versus 47.6 months for standard care. 患者接受14个周期超过14个月,开始在周期3的venetoclax与逐渐增加剂量. Patients receive 14 cycles over 14 months, starting venetoclax in cycle 3 with a gradual dose increase. 治疗为休歇治疗、提高生活质量和符合已知毒品风险的安全情况提供了潜力,包括肺炎、腹泻和COVID-19。 The treatment offers potential for time off therapy, improved quality of life, and a safety profile consistent with known drug risks, including neutropenia, diarrhea, and COVID-19. 批准标志着CLL护理方面的一个重大进步,其他一些国家正在审查综合护理情况。 The approval marks a significant advance in CLL care, with the combination under review in several other countries.