dabrafenib-trametinib

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Generic 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.
Key Milestones2
Call for patient/clinician/industry input open 17-Oct-24
Call for patient/clinician/industry input closed 6-Dec-24
Submission receivedOctober 11, 2024
Review initiatedOctober 11, 2024
Expert committee meeting (initial)March 20, 2025