2014年1月18日讯 --武田（Takeda）1月17日宣布，抗体偶联药物Adcetris（brentuximab vedotin）获日本卫生劳动福利部（MHLW）批准，用于2种适应症：（1）复发性或难治性CD30阳性霍奇金淋巴瘤（HL）成人患者；（2）复发性或难治性CD30阳性系统性间变性大细胞淋巴瘤（sALCL）成人患者。此前，日本MHLW已授予Adcetris治疗HL和sALCL的孤儿药地位，并授予Adcetris优先审查资格。
Adcetris的获批，是基于在日本复发性或难治性CD30阳性霍奇金淋巴瘤（HL）患者、复发性或难治性CD30阳性系统性间变性大细胞淋巴瘤（sALCL）患者中开展的一项I/II期临床试验、及2项全球性关键II期临床试验的数据。临床试验中，ADCETRIS已被证明能够在这2种适应症中，提供较高的总体反应率及持续完整响应。
关于Adcetris：
Adcetris是一种抗体偶联药物（ADC），由靶向CD30蛋白的一种单克隆抗体、以及一种微管破坏剂（单甲基auristatin E，MMAE），通过一种蛋白酶敏感的交联剂偶联而成，该偶联技术为西雅图遗传学公司（Seattle Genetics）的专有技术。CD30蛋白是经典HL及sALCL的明确标志物，而Auristatin E可通过抑制微管蛋白的聚合作用阻碍细胞分裂。Adcetris在血液中可稳定存在，在被CD30阳性肿瘤细胞内化后，可释放出MMAE。
此前，Adcetris已于2011年8月获FDA批准，于2012年10月获欧盟有条件批准，同时于2013年2月获加拿大批准。
Takeda Announces the New Drug Application Approval of ADCETRIS® (brentuximab vedotin) in Japan for the Treatment of Malignant Lymphoma
New Drug Approval of ADCETRIS® 50mg for intravenous drip infusion for the Treatment for Adult Patients with CD30-Positive Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large Cell Lymphoma
Osaka, Japan, January 17, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application of ADCETRIS® (brentuximab vedotin) (“ADCETRIS”) for the Treatment for Patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL).
The application approval was based on a phase 1/2 clinical trial in Japanese patients with relapsed or refractory CD30-positive HL and patients with relapsed or refractory CD30-positive systemic ALCL, and data from two global pivotal phase 2 clinical trials. In March 2012, MHLW granted ADCETRIS orphan drug designation for the treatment of patients with HL and ALCL, and therefore was targeted for priority review in Japan.
ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
"This approval brings us a step closer to providing a new treatment option to patients in Japan with relapsed or refractory HL and relapsed or refractory ALCL," said Michael Vasconcelles, MD, Head of the Oncology Therapeutic Area Unit. "We continually strive to bring more effective treatments to patients in areas with significant unmet medical needs."
Approval status of brentuximab vedotin in the US/Canada/EU
In the U.S., ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration in August 2011 and approval with conditions from Health Canada in February 2013 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
In the EU, ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30+ HL: (1) following autologous stem cell transplant (ASCT) or (2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with sALCL.
Seattle Genetics holds commercialization rights in the U.S. and Canada, while Takeda has right to commercialize ADCETRIS in all other countries.
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