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.
例
- Pembrolizumab for melanoma
- Ibrutinib for MCL
- Often combined with priority review
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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.