FDA授予百时美免疫疗法nivolumab突破性疗法认定

坤明

作者：tomato 来源：生物谷 2014-5-16 8:37:05
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8 {! f3 B3 s- C( K2014年5月15日讯 /生物谷BIOON/ --百时美施贵宝（BMS）5月14日宣布，FDA已授予实验性PD-1免疫检查点抑制剂nivolumab突破性疗法认定，用于治疗自体干细胞移植和brentuximab失败的霍奇金淋巴瘤（HL）患者的治疗。
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! z3 z  _( i6 Z, `. p: B* fNivolumab突破性疗法认定的授予，是基于一项正在复发性和难治性血液系统恶性肿瘤群体中开展的Ib期研究中HL群体的队列数据。
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% p/ N* @' E, F. L) J霍奇金淋巴瘤（HL）是一种源于白细胞的淋巴系统癌症。晚期HL患者群体，5年存活率约为65%。若复发性和难治性HL患者接受自体干细胞移植后一年内病情恶化，平均存活时间仅为1.3年。
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: b  ?& x' P/ V4 U关于Nivolumab（BMS-936559）:
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" Y6 S# G+ ~1 r, U癌细胞可能利用“调节子（regulator）”途径，如检查点（checkpoint）途径，逃避机体免疫系统，保护肿瘤免受免疫攻击。# C) B; a% l, d7 T8 M

" t; j6 S* B9 z" H) iNivolumab是一种实验性、全人源化IgG4、抗程序性死亡受体1（PD-1）单克隆抗体，能够抑制PD-1与程序性死亡配体1（PD-L1/B7-H1）和程序性死亡配体2（PD-L2/B7-DC）的结合。阻断PD-1与其配体的相互作用，可能使T细胞恢复抗肿瘤免疫应答。目前，百时美施贵宝正调查nivolumab用于恶性黑色素瘤、肾癌、非小细胞肺癌及其他癌症的治疗。
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nivolumab的开发项目研究总数超过25个：调查作为单药疗法或与其他药物联合用药，用于多个肿瘤类型的治疗，包括：非小细胞肺癌、小细胞肺癌、黑色素瘤、肾细胞癌、肝癌、血液癌症、三阴性乳腺癌、胃癌、胰腺癌。
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坤明

Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma
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Designation granted for nivolumab for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant followed by brentuximab  K: h6 K7 U+ y0 i; R

7 V3 j2 d  e+ s/ Z5 tPRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab. The designation is based on data from a cohort of patients with HL in the company’s ongoing Phase 1b study of relapsed and refractory hematological malignancies.
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. E6 z# n" B6 F# p, {According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
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: E/ A' F% |" `0 g1 p“The Breakthrough Therapy Designation granted by the FDA for nivolumab continues to support the development of innovative approaches designed to advance how cancer is treated,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences. “It is our goal to change the way patients live with cancer, especially in areas of high unmet medical need like Hodgkin lymphoma where patients may be underserved by currently available treatment options.”
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About Hodgkin Lymphoma, s0 U6 S7 U+ H$ k. k
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Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer of the lymphatic system, which originates in the white blood cells. HL is one of two main types of lymphomas. The five-year survival rate for advanced HL is approximately 65 percent in the U.S. If patients with relapsed and refractory HL progress within one year after receiving autologous stem cell transplant (the standard of care), the median survival is just 1.3 years after progression. The median age of diagnosis is 38 in the U.S. This year, more than 9,100 new cases are estimated to be diagnosed with more than 1,100 deaths expected.
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About Nivolumab
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. p! y) W: l8 C! }3 D( m9 PNivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. We are investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.  F2 y- `9 o; e/ _/ A9 @8 l6 e

  D. j5 W5 ^5 U9 j+ S, O9 `" KBristol-Myers Squibb has a broad, global development program to study nivolumab in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for nivolumab in NSCLC, melanoma and RCC.4 w7 U  a. {0 C# U5 M