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乳癌:KOL (キーオピニオンリーダー) による考察 (2017年)

Breast Cancer: KOL Insight [2017]

発行 FirstWord 商品コード 520358
出版日 ページ情報 英文
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=113.05円で換算しております。
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乳癌:KOL (キーオピニオンリーダー) による考察 (2017年) Breast Cancer: KOL Insight [2017]
出版日: 2017年06月01日 ページ情報: 英文
概要

当レポートでは、乳癌の主な上市済み薬剤および開発段階の薬剤を取り上げ、北米および欧州の12名のキーオピニオンリーダー (KOL) による各種見解をまとめています。

主な論点

  • いくつかのトラスツズマブバイオシミラー版が規制当局による審査中。KOLはこれらの製品をどのように見なし、また将来の使用方法をどのように想定しているか?
  • Perjetaは、HER2陽性疾患の補助療法として調査中。APHINITYの調査結果にはどのような影響があるか?
  • ネラチニブは補助療法としての承認待ち
  • Ibranceのその他の療法における承認のチャンスは?
  • アルファ特有PI3キナーゼ阻害薬、alpelisib およびtaselisibはCDK4/6阻害薬に対してどのように形成されるか?
  • Kisqaliは、HER2陰性/ HR陽性の乳癌に対する米国の承認を得る。効果的な競争のためにこの製品はどのようなメリットを示す必要があるか?
  • KOLは、PARP阻害剤およびチェックポイント阻害剤が三重陰性乳癌 (TNBC) においてどのように使用され得るかについて議論。これらの薬剤に関するKOLの考えはどのようなものか、また今後TNBCはどのようにを治療されると想定しているか?

調査対象薬の例

  • 上市済み薬剤
    • Herceptin (trastuzumab; Roche)
    • Kadcyla (ado-trastuzumab emtansine; Roche)
    • Perjeta (pertuzumab; Roche)
    • Tykerb/Tyverb (lapatinib; Novartis)
    • その他
  • 第3相
    • neratinib (PB 272; Puma Biotechnology)
    • margetuximab (MGAH 22; MacroGenics)
    • Gilotrif/Giotrif (afatinib; Boehringer Ingelheim)
    • Kisqali (ribociclib; Novartis)
    • その他

KOLインタビューの例

  • 北米のKOL
  • 欧州のKOL
目次

How is Ibrance faring? Is Kisqali expected to be a threat?

Having dominated the HER2-positive breast cancer space for many years, Roche's blockbuster drug Herceptin is likely to face the threat of biosimilar trastuzumab in the coming years; KOLs weigh in on how biosimilar trastuzumab may be accepted by physicians and patients, its potential usage in different settings, as well as its chances to become the preferred agent in the HER2-positive space. Meanwhile, KOLs discuss how Roche's Perjeta is setting itself up for expanded use. Experts also give their views on how Pfizer's Ibrance is faring in the HER2-negative/HR-positive space and what challenges lie ahead for this drug, including the arrival of Novartis' Kisqali and Eli Lilly's abemaciclib. The potential usage of PARP inhibitors and PD-1/PD-L1 checkpoint inhibitors in triple-negative breast cancer is also explored. Twelve US and EU KOLs offer their candid insights on these issues and more.

In this 6 US and six EU KOLs offer their candid insights on 6 marketed therapies and 12 pipeline drugs.

Plus: Order the report and you'll receive three quarterly FirstWord Therapy Trends Update Bulletins free!

Take a tour of the report now:

  • The table of contents
  • The key business questions answered
  • The key KOL quotes
  • See the therapies covered
  • Find out who the 6 EU & 6 US KOLs are
  • Review an extract from the report - 1 drug profile

Top Takeaways

  • Several biosimilar trastuzumab versions are under regulatory review. How do KOLs view these products and how do they envisage their future use?
  • Perjeta is under investigation as an adjuvant therapy for HER2-positive disease. What impact will the APHINITY study results have?
  • Neratinib is awaiting approval in the extended adjuvant setting. How do KOLs view this agent and is uptake likely to be significant?
  • What are Ibrance's chances of approval in other settings? And can Pfizer fend off competition from Kisqali and abemaciclib?
  • How do the alpha specific PI3 kinase inhibitors, alpelisib and taselisib shape up against the CDK4/6 inhibitors? KOLs offer their views on these agents and how they could be positioned.
  • Kisqali has received US approval for HER2-negative/HR-positive breast cancer. What benefits does this product need to show in order to compete effectively?
  • KOLs discuss how PARP inhibitors and checkpoint inhibitors may be used in triple-negative breast cancer (TNBC). What are KOLs' thoughts on these agents and how do they envisage TNBC to be treated in the future?

Quotes

“Alpelisib is clearly more selective or alpha specific. This should allow for better targeting but we'll see if that pans out clinically. I think we need to be careful with the toxicity of these drugs.” EU Key Opinion Leader.

“There are still studies that need to be completed to address the issue of sequencing of different therapies. The bulk of the evidence does support first-line use with a CDK4/6 inhibitor, but then after you get beyond first-line therapy, it starts to become a bit more confusing.” US Key Opinion Leader.

Sample of therapies covered

Marketed Therapies

  • Herceptin (trastuzumab; Roche)
  • Kadcyla (ado-trastuzumab emtansine; Roche)
  • Perjeta (pertuzumab; Roche)
  • Tykerb/Tyverb (lapatinib; Novartis)
  • Plus 2 more

Phase III

  • neratinib (PB 272; Puma Biotechnology)
  • margetuximab (MGAH 22; MacroGenics)
  • Gilotrif/Giotrif (afatinib; Boehringer Ingelheim)
  • Kisqali (ribociclib; Novartis)
  • Plus 8 more

Sample of KOLs interviewed

KOLs from North America

  • Dr. Charles L. Vogel, MD. Professor of Clinical Medicine, Division of Haematology/Oncology, Miller School of Medicine, University of Miami, Florida.
  • Dr. Adam M. Brufsky, MD, PhD. Professor of Medicine at the University of Pittsburgh School of Medicine, Pittsburgh, PA.
  • Dr. Joyce O'Shaughnessy, MD. Specialises in medical oncology with board certification in both internal medicine and medical oncology. She is a Diplomate of the American Board of Internal Medicine, with subspecialty certification in medical oncology.

KOLs from Europe

  • Dr. Thomas Bachelot, MD. Head of the Breast Cancer Unit and the Clinical Trial Unit at the Centre Leon Berard, Lyon, France.
  • Dr. Adrian L. Harris, MD, DPhil. Professor of Medical Oncology at the University of Oxford and Director of the Cancer Research UK Medical Oncology Unit, London, England.
  • Dr. Ahmad Awada, MD. Head of Medical Oncology Clinic at Jules Bordet Cancer Institute, Brussels, Belgium.
  • Plus 6 more

Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.

Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

  • Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date.
  • You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.
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