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Target Oncol. 2019 Oct;14(5):493-504. doi: 10.1007/s11523-019-00673-1.
Venetoclax (Venclyxto; Venclexta) is a first-in-class, oral, selective B cell lymphoma-2 (BCL-2) inhibitor. The drug is approved in numerous countries, including those of the EU and in the USA, for the treatment of adults with relapsed or refractory (RR) chronic lymphocytic leukemia (CLL); the specific indication(s) for venetoclax may vary between individual countries. Venetoclax monotherapy or combination therapy with rituximab was an effective treatment, provided durable responses, and had a manageable safety profile in pivotal clinical trials in adults with RR CLL, including in patients with adverse prognostic factors. In combination with 6 cycles of rituximab, venetoclax (fixed 24 months' treatment) was more effective than bendamustine plus rituximab (6 cycles) in prolonging progression-free survival (PFS) and inducing undetectable minimal residual disease (uMRD) in peripheral blood (PB) and bone marrow (BM), with these benefits sustained during 36 months' follow-up. Hence, with its novel mechanism of action and convenient oral once-daily regimen, venetoclax monotherapy or fixed 24-month combination therapy with rituximab represents an important option for treating RR CLL, including in patients with del(17p) or TP53 mutation and those failing a B cell receptor (BCR) inhibitor and/or chemotherapy.
维奈托克（Venclyxto；Venclexta）是一种首创的、口服的、选择性 B 细胞淋巴瘤-2（BCL-2）抑制剂。该药已在许多国家获得批准，包括欧盟国家和美国，用于治疗复发或难治性（RR）慢性淋巴细胞白血病（CLL）的成人患者；维奈托克的具体适应证可能因国家而异。在 RR CLL 成人患者的关键性临床试验中，维奈托克单药治疗或与利妥昔单抗联合治疗是一种有效的治疗方法，可提供持久的缓解，并具有可管理的安全性。在联合利妥昔单抗 6 个周期的治疗中，与苯达莫司汀联合利妥昔单抗（6 个周期）相比，维奈托克（固定治疗 24 个月）在延长无进展生存期（PFS）和诱导外周血（PB）和骨髓（BM）中不可检测的微小残留病（uMRD）方面更有效，这些益处在 36 个月的随访中持续存在。因此，维奈托克具有新颖的作用机制和方便的每日口服一次的治疗方案，无论是单药治疗还是固定的 24 个月联合利妥昔单抗治疗，都是治疗 RR CLL 的重要选择，包括伴有 del(17p)或 TP53 突变的患者，以及那些对 B 细胞受体（BCR）抑制剂和/或化疗失败的患者。
