Will Trodelvy show significant improvement in ES-SCLC clinical trials by end of 2025?
Yes • 50%
No • 50%
Clinical trial results published in scientific journals or press releases
FDA Grants Breakthrough Therapy Designation to Trodelvy for ES-SCLC Treatment
Dec 18, 2024, 12:06 PM
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the second-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This designation is intended to expedite the development and review of drugs that demonstrate substantial improvement over existing therapies for serious or life-threatening conditions. Trodelvy, developed by Gilead Sciences, has shown promise in addressing the needs of patients with ES-SCLC who have limited treatment options. The FDA's decision highlights the potential of Trodelvy to improve outcomes for this patient population.
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11-15 trials • 25%
More than 15 trials • 25%
0-5 trials • 25%
6-10 trials • 25%
Yes • 50%
No • 50%
No • 50%
Yes • 50%
Canada • 25%
European Union • 25%
Japan • 25%
Other • 25%
Increase by 5-10% • 25%
Increase by more than 10% • 25%
Increase by less than 5% • 25%
No significant change or decrease • 25%
Yes • 50%
No • 50%
Negative efficacy and safety concerns • 25%
Positive efficacy and safety results • 25%
Positive efficacy, but safety concerns • 25%
Negative efficacy, but good safety • 25%
Yes • 50%
No • 50%
Full Approval • 25%
No Approval • 25%
Conditional Approval • 25%
Accelerated Approval • 25%
Worse Outcomes • 25%
Significant Improvement • 25%
Moderate Improvement • 25%
No Change • 25%