4
Indication details
- Control Arm
- ChT (docetaxel or vinflunine)
- Therapeutic Indication
- For adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- FGFR3
- Trial Name
- THOR/BLC3001 cohort 1
- NCT Number
- NCT03390504
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2024 and granted accelerated approval in April 2019
- EMA Approval
- Not EMA approved
- Comment
- FDA confirmatory phase III trial of the single arm phase II study BLC2001
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 7.8 months
- OS Gain
- 4.3 months
- OS HR
- 0.64 (0.47-0.88)
Adjustments
- QoL Comment
-
QoL data pending
Final Score (after adjustments)
- Preliminary non-curative score
-
4
- Final non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 422
- Scorecard version
- 1
- Issue date
- 21.12.2023
- Last update
- 07.02.2024
Legend
Information about symbols, abbrevations and color codes
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: