3
Indication details
- Control Arm
- Single arm
- Therapeutic Indication
- Treatment of adults with RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Thyroid cancer - differentiated
- Tumour Stage
- Advanced
- Tumour Sub-Group
- RET fusion-positive
- Trial Name
- LIBRETTO-001 (Cohort 1)
- NCT Number
- NCT03157128
- Trial Phase
- Phase I/II
Approval details
- FDA Approval
- FDA accelerated approval May 2020. Traditional approval June 2024
- EMA Approval
- EMA (CHMP) December 2020 EC decision April 2021
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR, DOR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 20.1 months
- ORR
- 79%
- DoR
- 18.4 months
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 218
- Scorecard version
- 1
- Issue date
- 1.11.2020
- Last update
- 21.07.2023