强生向欧盟提交血癌药物Ibrutinib上市许可申请

强生（JNJ）旗下杨森（Jassen）10月30日宣布，已向欧洲药品管理局（EMA）提交了抗癌药物Ibrutinib的上市许可申请（MAA），寻求批准用于复发性或难治性慢性淋巴细胞白血病（CLL）/小淋巴细胞白血病（SLL）或复发性或难治性套细胞淋巴瘤（MCL）成人患者的治疗。

Ibrutinib是一种每日一次的口服Bruton酪氨酸激酶（BTK）抑制剂类药物。研究数据表明，ibrutinib共价结合恶性B细胞中的BTK，关闭主要的增殖和存活信号通路。

Ibrutinib由杨森与Pharmacyclics合作开发，目前正调查用于数种形式血癌的治疗。如果获批，Ibrutinib将成为上市的首个靶向BTK的药物。

今年7月10日，强生已向FDA提交了ibrutinib的新药申请（NDA），寻求批准用于既往治疗过的CLL/SLL或MCL患者的治疗。

CLL/SLL和MCL属于一组名为B细胞恶性肿瘤的血液癌症。许多患者在治疗后会复发，可能在治疗过程中使用数种药物。

关于Ibrutinib：

Ibrutinib是一种名为Bruton酪氨酸激酶（BTK）抑制剂的首创新药。BTK是一个重要的蛋白，参与介导调控B细胞成熟和生存的胞内信号通路。在恶性B细胞中，B细胞受体信号通路过度活跃，该信号通路即包括BTK。

Ibrutinib能够与BTK形成强有力的共价键，从而抑制恶性B细胞中过度活跃的细胞生存信号的传输。（生物谷Bioon.com）

英文原文：New Marketing Authorisation Application Submitted to EMA for Ibrutinib for the Treatment of Two Forms of Blood Cancer

The submission is for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and mantle cell lymphoma (MCL), two difficult-to-treat diseases
Beerse / Belgium, 30 October 2013– Janssen-Cilag International NV (Janssen) announced today it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood cancer.

Ibrutinib is administered orally, once-daily and is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data suggest ibrutinib covalently bonds to BTK in malignant B cells, shutting down major proliferation and survival pathways. Ibrutinib is being developed by Janssen with Pharmacyclics, Inc. for the treatment of several forms of blood cancer. If approved, ibrutinib will be the first commercially available therapy targeting BTK.

“The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib,” said Jane Griffiths, Group Company Chairman of Janssen Europe, the Middle East and Africa (EMEA). ”At Janssen, we are dedicated to developing solutions that prolong and improve the lives of patients. If approved, ibrutinib will address a great unmet need for patients with CLL/SLL and MCL who have previously failed or become resistant to previous treatment.”

The EMA filings follow the New Drug Application submission of ibrutinib to the U.S. Food and Drug Administration which was announced on 10 July 2013, for its use in the treatment of previously treated patients with CLL/SLL or MCL.

CLL/SLL and MCL belong to a group of blood cancers, known as B-cell malignancies, originating from B cells, a type of white blood cell (lymphocyte).[1] CLL/SLL and MCL, are complex diseases that can be challenging to treat. As a result, many patients will relapse after a specific treatment and may require multiple treatments over the course of their disease.

About Ibrutinib
Ibrutinib is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. BTK is an important protein involved in mediating the cellular signaling pathways which control B cell maturation and survival. In malignant B cells, there is excessive signaling through the B cell receptor signaling (BCR) pathway, which includes BTK. The malignant cell ignores the natural signal to die and continues to develop and proliferate.  Malignant cells migrate and adhere to protective environmental areas such as the lymph nodes where they proliferate and survive. Ibrutinib is the first in a new class of drugs specifically designed to target and inhibit BTK. Ibrutinib forms a strong covalent bond with BTK, which inhibits the excessive transmission of cell survival signals within the malignant B cells and stops their excessive build up in these protected environmental areas. The efficacy and safety of ibrutinib alone and in combination with other treatments is being studied in several blood cancers.[2,3,4,5,6]