Last Updated : January 7, 2025
Details
FilesGeneric Name:
dabrafenib-trametinib
Project Status:
Active
Therapeutic Area:
Pediatric low grade glioma (ped LGG)
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
PX0375-000
Call for patient/clinician input closed:
Biosimilar:
No
Submission Type:
Non-sponsored Submission
Fee Schedule:
Pending
Indications:
in pediatric and young adult patients for 1st line or greater therapy in low grade gliomas with residual disease and with known BRAF V600 mutations.
| Call for patient/clinician/industry input open | 17-Oct-24 |
|---|---|
| Call for patient/clinician/industry input closed | 6-Dec-24 |
| Submission received | October 11, 2024 |
| Review initiated | October 11, 2024 |
| Expert committee meeting (initial) | March 20, 2025 |
Files
Last Updated : January 7, 2025