2010年8月20日金曜日

FDA ベバシズマブ認可取消検討

FDAはベバシズマブの認可取消を検討とのこと。
 FDAが乳がん治療薬「アバスチン」(一般名ベバシズマブ)の認可取消しを
検討していると報じた。科学者らで構成する諮問機関が、薬効より副作用
の危険性が大きいと勧告したという。FDAは9月17日までに結論を出す見通し。

アバスチン(Roche Holding AG)
 結腸、直腸、肺、腎臓、脳のがんの治療薬として認可
 2008年に乳がん治療薬として認可
 年におよそ17500人の人に処方されるベストセラー
 転移性乳がんだけ認可取消しを検討
 出血、消化管穿孔、血栓や心臓まひなど重大な副作用の可能性
 延命効果が認められないと結論

アバスチンは、重篤な副作用が発生する確率が高いと報告されていたようだ。
それでも、使用者は年に17500人もいる。
乳がんで毎年、400,000人の女性が死亡。
番組宣伝のために、科学的根拠のない乳がん検診をそそのかすメディアも
ある。
日本でも、中外製薬から厚労省へ申請され、乳がんに関しても、フェーズ2
までは、副作用を伴うが、抗がん剤と併用することで効果があると研究発表
している。
FDAが、アバスチンの乳がんへの投与認可を取消した場合、厚労省も認可を
取消すのだろうか。
アバスチンは政治が背景にあるのか。

日本人のHER2陰性転移性乳癌でベバシズマブとパクリタキセル併用がPFSを改善【ASCO2010】
唾液検査でがん発見


---乳がん治療薬「ベバシズマブ」の認可取り消し検討 米当局---
2010.8.16 14:45
http://sankei.jp.msn.com/world/america/100816/amr1008161449007-n1.htm

 16日付の米紙ワシントン・ポストは、米食品医薬品局(FDA)が乳がん治療薬「アバスチン」(一般名ベバシズマブ)の認可取り消しを検討していると報じた。科学者らで構成する諮問機関が、薬効より副作用の危険性が大きいと勧告したという。
 FDAは9月17日までに結論を出す見通し。アバスチンは肺がんや腎臓がんの治療薬としても認可されているが、今回の勧告は乳がんだけを対象としている。
 FDAは2008年にアバスチンを乳がん治療薬として認可した。諮問機関は新たな二つの研究結果に基づき、延命効果が認められないと結論づけた。血栓や心臓まひなど重大な副作用の可能性があるという。(共同)


---FDA considers dropping Avastin approval, approves five-day emergency contraception pill---
17. August 2010 02:51
http://www.news-medical.net/news/20100817/FDA-considers-dropping-Avastin-approval-approves-five-day-emergency-contraception-pill.aspx

The Food and Drug Administration is considering revoking its approval of a last-ditch breast cancer drug over the debate on "medical spending and effectiveness that flared during the battle over health-care reform," The Washington Post reports. "The [FDA] is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded. Citing a dearth of evidence of the drug's effectiveness, its potential toxic side effects, and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin's authorization for breast cancer might be repealed." But this possibility is causing alarm among some cancer specialists as well as members of Congress and women taking the drug. The drug is prescribed to about 17,500 women a year and is the world's best-selling cancer drug with global sales of $5.8 billion. "The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment." Avastin is approved for use in treating colon, lung, kidney and brain cancer, as well as some other forms of the disease. "So doctors could continue to write prescriptions for it for breast cancer, as an 'off-label' use" (Stein, 8/16).

On a separate note, the FDA has approved an emergency contraceptive, ella, that is supposed to block pregnancy for up to five days after sex, "two days longer than the currently available emergency contraceptive Plan B," The Wall Street Journal reports. "The FDA's review of the product reignited a long-running debate over the effects of such emergency contraceptives. Some antiabortion groups argue products such as ella can act to end pregnancies, rather than simply prevent them." Drugmaker Watson Pharmaceuticals says the drug is used to prevent ovulation (Wilde Mathews and Corbett Dooren, 8/14).


---Roche's Avastin Fails to Convince U.S. Panel---
JULY 21, 2010, 1:23 P.M. ET
By GORAN MIJUK
http://online.wsj.com/article/SB10001424052748704684604575381161403795070.html?mod=googlenews_wsj

ZURICH-Roche Holding AG came under pressure Wednesday after a U.S. regulatory panel said the Swiss pharma giant's cancer drug Avastin failed to show hoped-for benefits in treating breast cancer, potentially erasing hundreds of millions of dollars in sales and raising doubts about the company's drug-development setup in the wake of recent development failures.

The Oncology Drugs Advisory Committee, or ODAC, of the U.S. Food and Drug Administration, or FDA, Tuesday voted against a broader label for Avastin and recommended the FDA to revoke the provisional approval for the breast-cancer indication due to a lack of benefit when compared to the drug's risks.

Avastin is one of Roche's best-selling cancer drugs, having netted more than 6 billion Swiss francs, or about $5.7 billion, in revenue in 2009. The drug is approved to treat colon, lung, and other cancers. While it is approved in the European Union to treat breast cancer, the same indication has only been provisionally approved in the U.S.

The FDA is expected to decide by September 17 whether to fully approve the drug to treat breast cancer or to drop the label. The FDA usually, but not always, follows the recommendations by advisory panels. In 2008, the FDA granted Roche's Avastin a provisional approval to treat breast cancer even though the panel voted against such a move.

Roche said it will continue to work together with regulators and said it was convinced its large trials showed that Avastin improved progression-free survival in breast cancer patients. Breast cancer kills nearly 400,000 women every year.

Shares of Roche, which have already shed nearly 20% this year due to several drug pipeline failures, dropped 4.2% Wednesday.

The FDA panel's vote triggered analyst concerns that besides losing sales contribution of around 500 million francs for treating patients with breast cancer in the U.S., the negative verdict could also affect other cancer indications and prompt other regulators to reconsider their views.

"The negative ... vote will raise doubts over a U.S. approval of Avastin in ovarian cancer and also give rise to a potential change in the EU label, although yesterday's decision isn't linked to any of the two," UBS pharma analyst Fabian Wenner said. Due to the negative decision, Mr. Wenner said he doubts the FDA will grant an approval for Avastin in breast cancer.

Other analysts said Roche is likely to cut its peak sales estimate for Avastin by about 1 billion francs or more. Previously the market had expected Avastin to reach peak sales of about 9 billion francs before the drug's patent will start to expire. Roche will report half-year earnings on Thursday.

Meanwhile, J.P. Morgan said the negative panel verdict could trigger a restructuring at the Swiss company as Roche will have to cut costs to make up for the shortfall in sales. They suggested Roche could cuts sales staff and curb marketing costs.

"However, we hope that in view of two major disappointments in the last four weeks, Roche may question their entire Pharma set-up and consider a more comprehensive restructuring," J.P. Morgan said in a research note.

Roche in late June released disappointing trial data for its experimental diabetes drug taspoglutide. The medicine not only had a potential to reach sales of more than 2 billion francs but also carried the hope the drug would help reduce Roche's dependence on cancer drug, which make up the bulk of the company's revenues.

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