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Market
How many major competitors will be approved for HR+/HER2- breast cancer by end of 2025?
2
Resolution / Starting Odds
None • 25%
One • 25%
Two • 25%
More than two • 25%
FDA announcements and press releases
Story
FDA Approves Datopotamab Deruxtecan With Improved PFS for Advanced HR+/HER2- Breast Cancer
Jan 17, 2025, 12:23 PM
The FDA has approved datopotamab deruxtecan (Datroway) for the treatment of unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer in adults who have previously received endocrine-based therapy and chemotherapy. The approval is supported by the TROPION-Breast01 trial, which showed a median progression-free survival of 6.9 months for Datroway compared to 4.9 months for chemotherapy (HR, 0.63). The trial also reported a median overall survival of 18.6 months for Datroway versus 18.3 months for chemotherapy. Common adverse effects included stomatitis, nausea, and fatigue. Datopotamab deruxtecan is co-developed by AstraZeneca and Daiichi Sankyo, marking a significant advancement in targeted cancer therapies.
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Enhertu (trastuzumab deruxtecan) • 25%
Verzenio (abemaciclib) • 25%
30 to 60 countries • 25%
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Pfizer • 25%
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Roche • 25%
Novartis • 25%
10% to 15% • 25%
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Europe • 25%
Asia • 25%
North America • 25%
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40% to 60% • 25%
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Yes • 50%
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Roche • 25%
AstraZeneca • 25%
Johnson & Johnson • 25%
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Three or more • 25%
One • 25%
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None • 25%
Other • 25%
Bristol-Myers Squibb • 25%
Merck & Co. • 25%
Pfizer • 25%