Related Experiment Video
Updated: Feb 10, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Abstract:
Cancer drugs approved as FDA breakthrough therapies are not necessarily better than those approved through the traditional pathway: Although breakthrough-designated cancer drugs were approved in less time, a recent study reported, they were not associated with gains in progression-free survival or response rates, nor were they safer or more novel than non-breakthrough-designated drugs.
Insights
FDA breakthrough therapy designation for cancer drugs does not guarantee superior outcomes. A study found these drugs were approved faster but showed no significant improvements in survival, response rates, safety, or novelty compared to traditional pathways.
Area of Science:
- Oncology
- Drug Approval Processes
- Clinical Trials
Background:
- The U.S. Food and Drug Administration (FDA) offers a breakthrough therapy designation to expedite the development and review of drugs for serious conditions.
- Understanding the real-world clinical benefits of breakthrough-designated cancer drugs compared to those approved via traditional routes is crucial for oncologists and patients.
Related Concept Videos
Benefits of Self-Esteem
Cancer
Pharmacokinetics: Drug–Drug Interactions
What is Cancer?
Although people have known about cancer for centuries, it was only in 1761 that Giovanni Morgagni of Padua performed a detailed autopsy of...
Bioequivalence of Drugs: Drugs with Multiple Indications
FDA Approved Drugs: Changes to Approved Drugs

