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罗氏乳腺癌新药Kadcyla遭英国NICE拒绝

  1. HER2阳性
  2. Kadcyla
  3. 乳腺癌新药
  4. 罗氏

来源:生物谷 2014-04-24 09:00

罗氏乳腺癌新药Kadcyla遭英国NICE拒绝,该药是首个获批用于HER2阳性转移性乳腺癌治疗的抗体偶联药物(ADC)。

2014年4月23日讯 /生物谷BIOON/ --英国国家健康与临床卓越研究所(NICE)发布指南草案,拒绝罗氏(Roche)一种新的乳腺癌药物Kadcyla用于英国国家卫生服务(NHS),理由是该药不具有成本-效益。

NICE预计,接受Kadcyla治疗的患者,一个疗程费用将达9.0831万英镑(约合15.28万美元)。目前,NICE一直在评估Kadcyla用于不能手术切除的局部晚期或转移性HER2阳性乳腺癌患者的治疗。NICE行政长官Andrew Dillon在声明中称,希望罗氏能够认识到英国国家卫生服务(NHS)系统在管理昂贵新药采购方面所面临的挑战,并希望罗氏能降低Dadcyla的价格。

Kadcyla已于2013年11月获欧盟批准,是首个获批用于HER2阳性转移性乳腺癌治疗的抗体偶联药物(ADC)。

Kadcyla是一种HER2靶向性疗法,是一种由罗氏曲妥珠单抗与ImmunoGen公司DM1细胞毒制剂相偶联的药物,具有2种抗癌属性:曲妥珠单抗的HER2抑制和DM1的细胞毒性。曲妥珠单抗和DM1之间采用一种稳定的连接子(linkers)偶联,将DM1递送至HER2阳性乳腺癌细胞。罗氏拥有Kadcyla的全球开发和商业化权利。

目前,罗氏正在开展数个研究,评价Kadcyla用于潜在额外用途的潜力,包括用于HER2阳性转移性乳腺癌的一线治疗,用于早期HER2阳性乳腺癌、晚期HER2阳性胃癌的治疗。(生物谷Bioon.com)

英文原文:New Roche breast cancer drug unaffordable, says UK body

(Reuters) - A new breast cancer drug from Roche that costs tens of thousands of pounds more than other treatments is unaffordable for Britain's state-run health service, the country's healthcare cost watchdog said on Wednesday.

The National Institute for Health and Clinical Excellence (NICE) said Kadcyla was not effective enough to justify the price tag, which can is expected to reach 90,831 pounds ($152,800) per patient for a course of treatment.

The rebuff from the body responsible for deciding if drugs should be used on the National Health Service (NHS) formed part of a growing debate about the high price of modern medicines, especially those for treating cancer.

NICE has been assessing Kadcyla as a treatment for women with so-called HER2-positive breast cancer that has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.

"We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS," NICE Chief Executive Andrew Dillon said in a statement.

"We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer."

NICE's draft guidance recommending against Kadcyla's routine use is now open for consultation and Dillon said he hoped Roche would look again at the price. ($1 = 0.5944 British Pounds) (Reporting by Ben Hirschler; Editing by Angus MacSwan)

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