dabrafenib trametinib

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Generic Name:

Project Status:

Active

Therapeutic Area:

Pediatric low grade glioma (ped LGG)

Manufacturer:

N/A

Call for patient/clinician input open:

October 17, 2024

Brand Name:

TBC

Project Line:

Reimbursement Review

Project Number:

PX0375-000

Call for patient/clinician input closed:

December 6, 2024

NOC Status at Filing:

N/A

Biosimilar:

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
Milestones title	Date
Submission received	11-Oct-24
Review initiated	11-Oct-24
Expert committee meeting (initial)	20-Mar-25
Draft recommendation posted for stakeholder feedback	11-Apr-25
End of feedback period	29-Apr-25
Final recommendation posted	-
CDA-AMC review report(s) posted	-