Panobinostat: First Global Approval
Panobinostat: First Global Approval
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DOI：
10.1007/s40265-015-0388-8
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发表时间：
2015-04-01
期刊：
影响因子：
11.5
通讯作者：
Garnock-Jones, Karly P.
中科院分区：
文献类型：
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作者：
Garnock-Jones, Karly P.
诺华公司已经开发了口服和静脉注射帕比司他（Farbinostat（A（R）），组蛋白脱乙酰酶（HDAC）抑制剂，用于治疗癌症。HDAC在维持染色质结构和调节基因表达（包括肿瘤抑制基因的表达）中具有重要作用，因此代表了寻找癌症治疗剂的有效靶点。口服帕比司他在美国获批，作为硼替佐米和地塞米松的联合治疗，用于至少接受过两种既往治疗方案（包括硼替佐米和免疫调节剂）的复发性多发性骨髓瘤患者。在欧盟和日本，已经提交了关于帕比司他联合治疗复发性多发性骨髓瘤患者的监管申请。Panobinostat在全球范围内处于各种血液肿瘤和实体肿瘤的临床开发阶段。本文总结了帕比司他开发的里程碑，导致首次批准用于多发性骨髓瘤。
Novartis has developed oral and intravenous formulations of panobinostat (Farydak(A (R))), a histone deacetylase (HDAC) inhibitor, for the treatment of cancer. HDACs have important roles in maintaining chromatin structure and in regulating gene expression, including that of tumour suppressor genes, and thus represent valid targets in the search for cancer therapeutics. Oral panobinostat is approved in the US, as combination therapy with bortezomib and dexamethasone in patients with recurrent multiple myeloma who have received at least two prior treatment regimens, including bortezomib and an immunomodulatory agent. Regulatory submissions have been made for the use of combination therapy with panobinostat in patients with recurrent multiple myeloma in the EU and Japan. Panobinostat is in various stages of clinical development worldwide for a range of haematological and solid tumours. This article summarizes the milestones in the development of panobinostat leading to this first approval for multiple myeloma.