Breakthrough Therapy Designation (BTD)
BTDFDA designation for drugs showing substantial improvement over existing treatments for serious conditions. Provides intensive FDA guidance, rolling review, and organizational commitment for expedited development.
Exemples
- Pembrolizumab for melanoma
- Ibrutinib for MCL
- Often combined with priority review
Le saviez-vous ?
FDA designation for drugs showing substantial improvement over existing treatments for serious conditions. Provides intensive FDA guidance, rolling review, and organizational commitment for expedited development.