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.
Examples
- Pembrolizumab for melanoma
- Ibrutinib for MCL
- Often combined with priority review
Did You Know?
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.