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一举拿下全球2大市场——吉利德首个肿瘤学药物Zydelig提交完美答卷 来源:生物谷 2014-09-21 10:42
2014年9月21日讯 /生物谷BIOON/ --吉利德(Gilead)首个肿瘤学药物Zydelig果然不负众望,2个月不到,一举拿下美欧2大市场。该药于今年7月获FDA批准,近日又获欧盟批准。业界此前预测,Zydelig在2017年的销售额将突破15亿美元。此次拿下欧洲市场,尽管毫无疑问的是,吉利德将面临欧洲医疗机构要求限制Zydelig定价的压力,但Zydelig将轻松实现业界预期这一点已毋庸置疑,该药也当之无愧的成为吉利德肿瘤管线中的一枚重磅明星药物。
吉利德在3年时间内通过收购匆忙拼凑出了肿瘤学部门,而Zydelig接连拿下全球2大市场,也是其肿瘤学部门交出的首份完美答卷。不过,吉利德寄予厚望的单抗药物simtuzumab近日在胰腺癌II期研究中失败,对其肿瘤学部门是个不小的打击。(点击生物谷文章:《刚雄起就遭创——吉利德肿瘤学受创,单抗simtuzumab胰腺癌II期失败》)
7月拿下美国市场:
Zydelig(idelalisib)是一种首创的高度选择性、口服有效的磷酸肌醇3-激酶delta(PI3K-delta)抑制剂。今年7月,FDA批准Zydelig,用于3种B细胞血癌的治疗,分别为:(1)批准Zydelig联合罗氏(Roche)抗癌药美罗华(Rituxan,通用名:rituximab,利妥昔单抗),用于适合Rituxan单药疗法的复发性慢性淋巴细胞白血病(CLL)患者的治疗;(2)批准Zydelig作为单药疗法,用于既往接受过至少2种系统治疗方案的复发性滤泡B细胞非霍奇金淋巴瘤(FL)患者和小细胞淋巴瘤(SLL)患者的治疗。FDA加速批准Zydelig用于FL和SLL适应症,是基于总缓解率(ORR)数据。
9月拿下欧洲市场:
近日,欧洲药品管理局(EMA)批准Zydelig用于2种B细胞血癌的治疗,分别为:(1)批准Zydelig联合罗氏美罗华(Rituxan,通用名:rituximab,利妥昔单抗),用于既往接受至少1种疗法的慢性淋巴细胞白血病(CLL)成人患者的治疗,(2)批准Zydelig联合Rituxan作为一线疗法,用于存在17p删除或TP53突变且不适合化疗-免疫疗法的CLL患者的治疗;(3)作为单药疗法,用于既往接受过2种系统治疗方案后复发的滤泡性淋巴瘤(FL)成人患者的治疗。
Zydelig在欧盟的获批,是基于2项研究(Study 116,Study 101-09)的积极数据。Study 116是一项关键性III期研究,在既往已接受治疗但对标准化疗不耐受的慢性淋巴细胞白血病(CLL)患者中开展,调查了Zydelig联合Rituxan用于经治CLL患者的疗效和安全性。一项既定中期分析数据表明,与安慰剂+美罗华(Rituxan)治疗组相比,Zydelig+Rituxan治疗组在研究的主要终点—疾病无进展生存期(PFS)具有统计学意义的显著改善(PFS:10.7个月 vs 5.5个月,p<0.0001)。
Study 101-09是一项关键II期研究,在既往经美罗华(Rituxan)和含烷化剂化疗方案治疗的难治性惰性非霍奇金淋巴瘤(iNHL,注:FL和SLL是2种类型的iNHL)患者中开展,评价了Zydelig的疗效和安全性。研究结果表明,Zydelig单药疗法取得了57%的总缓解率(ORR),其中,6%的患者实现了完全缓解,50%的患者实现部分缓解,1%的患者取得轻微缓解。研究中,平均缓解持续时间达12.5个月,距离缓解的平均时长为1.9个月,平均无进展生存期为11.0个月,平均总生存期为20.3个月,90%的患者经历了淋巴结的缩小。
慢性淋巴细胞白血病(CLL)和滤泡性淋巴瘤(FL)是2种生长缓慢但无法治愈的血癌,可导致严重危机生命的并发症,如贫血、严重感染和骨髓衰竭。复发通常发生在初始化疗-免疫疗法治疗后,同时,有许多复发型CLL和FL患者对化疗不耐受,可能会限制其治疗方案。
定价压力:
目前,尚未传出吉利德如何对Zydelig定价,但该公司可能会面临一些问题,尤其是来自英国药品成本/效益评估部门——英国国家卫生与临床优化研究所(NICE)的压力。NICE负责监督英国的药品价格,并决定哪些药物的开支由政府支付。最近,NICE已拒绝好几个昂贵抗癌药,包括罗氏(Roche)的乳腺癌药物Kadcyla和强生(JNJ)的前列腺癌药物Zytiga。
今年9月,NICE曾威胁道,今后评估新药的价值时,将干脆绕过制药公司,转而去欧洲药品管理局(EMA)获取临床试验数据。吉利德丙肝明星药物Sovaldi因售价太高,已经遭到了NICE的抵触情绪。目前,Sovaldi在英国的售价为57000美元/疗程,相比比美国售价84000美元/疗程已低了不少,但NICE仍在今年6月再次找吉利德谈话,要求提供更多的证据,证明Sovaldi值这么高的价格,NICE预计将在下个月发布最终审查结果。
有分析师报告称,在美国,吉利德已将Zydelig定价低于其主要竞争对手强生的Imbruvica(ibrutinib),Zydelig定价为7200美元/月,而Imbruvica价格为8200美元/月。然而,当Zydelig联合罗氏美罗华(Rituxan)用药时,该药治疗方案的成本将上升至12000元/月。
市场竞争:
价格因素是一方面,分析师指出,由于Zydelig的药物标签包含一个黑框警告,告诫消费者警惕该药潜在的副作用,如肠炎、肺部炎症和潜在致命的肝脏问题,因此,在美国,Zydelig的市场接纳速度可能会放缓,而强生Imbruvica没有黑框警告。同时,Zydelig在不久后也将面临另一个竞争对手,艾伯维(AbbVie)开发的ABT-199已处于后期临床,该药的临床表现也非常出色,有望成为首创Bcl-2抑制剂。据彭博社数据,ABT-199在2018年的销售额将达到10亿美元,2020年销售额将达到19亿美元。(生物谷Bioon.com)
英文原文:Europe approves Gilead's cancer drug Zydelig amid challenging pricing environment
Less than two months after the FDA approved Gilead Sciences' ($GILD) first cancer drug, Zydelig, the European Medicines Agency (EMA) has followed suit, green-lighting the drug for use in treating two blood cancers. The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.
Zydelig is among a new class of drugs known as PI3k inhibitors. It was approved in the U.S. to treat chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma. The EMA approved the drug for use in CLL and FL. In CLL, the approval was supported by late-stage data showing that when added to Roche's ($RHHBY) Rituxan, Gilead's drug prevented the cancer for progressing for twice as long as Rituxan alone, according to the Gilead statement. The EMA approved the drug for treating FL based on Phase II data showing an overall response rate of 54%.
"Although chemo-immunotherapy is initially used to treat both CLL and FL, relapse is common and many patients run out of treatment options to treat the disease as it progresses," said Peter Hillmen, a professor and hematologist at Britain's Leeds Teaching Hospitals NHS Trust, in a statement released by Gilead. "Thus, Zydelig is a welcomed treatment option that offers a new approach in the management of these cancers."
No word yet on how Gilead plans to price Zydelig in Europe, but the company will likely face questions, particularly from the National Institute for Health and Care Excellence (NICE), the U.K.'s drug-price watchdog, which decides what drugs will be covered by the government. NICE has said "no" to several pricey cancer drugs lately, including Roche's Kadcyla for breast cancer, and Johnson & Johnson's ($JNJ) prostate cancer treatment Zytiga.
In September, NICE threatened to bypass drugmakers altogether when assessing the value of new drugs and instead go to the EMA to obtain clinical trial data.
Gilead itself has gotten some pushback from NICE on its new hepatitis C treatment Sovaldi. The drug is priced at $57,000 a course in the U.K.--much lower than its $84,000 price in the U.S.--but NICE still went back to Gilead in June and asked for more evidence that Sovaldi is worth its price. NICE is expected to issue its final appraisal on Sovaldi next month.
In the U.S., analysts are reporting that Gilead has priced Zydelig lower than its top competitor, Johnson & Johnson's Imbruvica (ibrutinib)--$7,200 per month vs. $8,200. When added to Rituxan or another cancer treatment, however, the cost of Gilead's therapy could rise to $12,000, they estimate.
Zydelig won't be competing for market share on price alone. Analysts warn that in the U.S., pickup could be slowed by a black-box warning on the product that highlights such side effects as colitis, lung inflammation and potential fatal liver problems. Imbruvica doesn't have a black box. And there's more competition to come: AbbVie's ($ABBV) Rituxan add-on, ABT-199, is in late-stage development.
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