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zoom RSS 乳がんに対するアバスチンの承認取り消し/FDA

<<   作成日時 : 2011/11/19 22:18   >>

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乳がんに対するアバスチンの承認取り消し/FDA
 リスクを正当化するのに十分な効果がなかったとして、FDAは乳がんに対するロシュ社のアバスチンの承認を撤回した。
 2008年に承認された薬剤だが、その後の研究により、アバスチンは進行乳がんの延命やQOLの向上に役立つと確認できていないと、FDA長官マーガレットハンバーグは述べた。
 結腸、肺、腎臓および脳の癌の治療薬として、市場に残る。医師は適応外使用の裁量権は持っているが、健康保険での年間88000ドルのカバーはなくなる可能性がある。推計で17,000人の女性が治療を受け、有効例は充分あるとの主張もある。
 ロシュは、化学療法薬パクリタキセルとの併用でアバスチンの新たな第V相試験を実施すると発表した。76億ドルの年間売り上げを期待しているが、FDAの決定により10億ドルが低下するだろうという。

 乳がんは皮膚がんに次いで女性で二番目に多いガンである。米国女性の8人に1人に発症する。
 アバスチンは標準的化学療法との組み合わせでガンの増殖を5.5ヶ月停止したとされたが、その後の研究では1-3ヶ月の延長に過ぎず、進行癌患者の延命効果は認めなかったうえに、3%の患者で胃腸穿孔や出血・血栓などの重症副作用がみられた。

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米で乳がん治療薬承認取り消し 高血圧など副作用の恐れ
2011年11月19日 12時40分
http://www.tokyo-np.co.jp/s/article/2011111901000200.html
 【ワシントン共同】米食品医薬品局(FDA)は18日、新しいタイプの抗がん剤アバスチン(一般名ベバシズマブ)を乳がん患者に使う承認を取り消すと発表した。
 新たな臨床試験の結果、高血圧や心臓発作などの副作用の恐れがある一方で、明確な延命効果が確認できなかったことが理由。この薬は大腸がんや肺がんでも承認されているが、今回の取り消しは乳がんだけが対象。
 日本でも厚生労働省が9月、再発乳がんや手術ができない患者を対象に、別の抗がん剤と併用する治療を承認している。
 アバスチンは、がん細胞に酸素や栄養を送る血管ができるのを抑える「血管新生阻害薬」として開発された。

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FDA revokes approval of Avastin for breast cancer
http://www.reuters.com/article/2011/11/18/us-fda-avastin-idUSTRE7AH1Q120111118

By Alina Selyukh and Anna Yukhananov
WASHINGTON | Fri Nov 18, 2011 2:32pm EST

画像(Reuters) - Drug regulators withdrew their approval of Roche's Avastin for breast cancer, saying the drug was not effective enough to justify its risks even if patients believe it has helped them live longer.

Reversing course on a drug that was approved for the disease in 2008, U.S. Food and Drug Administration Commissioner Margaret Hamburg said subsequent research did not confirm hopes that Avastin would help patients with advanced breast cancer live longer or improve quality of life.

The drug will remain on the market for other uses, such as treating types of colon, lung, kidney and brain cancer.

"This was a difficult decision," Hamburg said. "With so much at stake, patients and their doctors count on the FDA to ensure the drugs they use have been shown to be safe and effective for their intended use. Sometimes, the results of rigorous testing can be disappointing."

While doctors still have discretion in using Avastin for breast cancer off-label, the FDA move may lead health insurers to drop coverage of a medicine that costs $88,000 a year.

An estimated 17,000 women are being treated with the drug, and patient advocates insist there are enough examples of survival to justify its use.

"The bottom line is that they are throwing out the baby with the bathwater," said Dr. Elisa Port, co-director of the Dubin Breast Center of Mount Sinai Hospital in New York. "There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin."

Roche said it will pursue a new Phase III study of Avastin in combination with the chemotherapy drug paclitaxel to look for biological clues about which breast cancer patients may benefit from the drug, clinically known as bevacizumab.

The Swiss drugmaker still expects Avastin, its top medicine, to generate peak annual sales of 7 billion Swiss francs ($7.6 billion), despite the FDA's decision. Analysts have said a withdrawn FDA approval for breast cancer could cost nearly $1 billion in sales.

Roche stock ended 0.5 percent lower at 142.60 Swiss francs in Switzerland on Friday. Its decline was in line with a 0.7 percent fall in the European healthcare index.

MEDICARE STILL PLANS TO COVER

The FDA determined in December 2010 that it should revoke its approval of Avastin for breast cancer, but an appeal from Roche and the outcry from patients led it to convene a hearing of advisers in June.

Some insurers have already started pulling back on Avastin coverage for breast cancer. But the U.S. government's Medicare insurance program will continue covering Avastin for the use, said a spokesman for the Centers for Medicare and Medicaid.

"CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies," spokesman Don McLeod said.

European regulators actually relaxed curbs on the use of Avastin in breast cancer this summer to allow its use with Xeloda, another type of chemotherapy drug that is also made by Roche. It was first approved for use with paclitaxel both in Europe and the United States.

The Susan G. Komen for the Cure foundation, the world's largest breast cancer organization, said the decision should lend urgency to the need for research showing whether specific patients are likelier to benefit from Avastin.

"We know that this decision was a difficult one for the FDA and respect the length of time they spent deliberating the many issues that impact patients," Komen foundation president Elizabeth Thompson said in a statement.

The FDA's decision could also prompt a review of industry guidelines from groups including the National Comprehensive Cancer Network, which represents leading cancer treatment centers. NCCN has so far not strayed from its earlier guideline, approving use of Avastin with paclitaxel for some patients.

Breast cancer is the second-most common type of cancer among women after skin cancer. One in eight U.S. women are expected to develop invasive breast cancer during their lives.

Avastin won U.S. clearance for the disease based on a study showing it stalled breast cancer growth by 5.5 months when used in combination with standard chemotherapy.

Later studies found only a one-to-three-month delay in breast cancer growth. None of the studies showed Avastin extended the lives of patients with advanced breast cancer.

Some patients also had severe side effects, including holes in the stomach and intestines, severe bleeding and blood clots. The company says the incidence of these serious side effects was just under 3 percent greater for those taking Avastin.

$1 = 0.9165 Swiss franc

(Additional reporting by Ben Hirschler in London, editing by Michele Gershberg, John Wallace and Matthew Lewis)

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