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pp-133

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Adult melanoma and other BRAF-altered solid tumours (Phase 2); approved for paediatric LGG (Ojemda) Clinical stage: Phase 2 — adult expansion trials ongoing Modality: Small molecule Mechanism / Target: Pan-RAF inhibitor — active against BRAF V600E/K and non-V600 BRAF mutations and fusions; brain-penetrant; avoids paradoxical MAPK pathway activation Route / form: Oral tablet (once weekly — unique dosing schedule) Differentiation: First approved RAF inhibitor for paediatric brain tumours; once-weekly dosing; CNS penetration; active against diverse BRAF alterations including fusions
Manufacturer #39167

Oncology company developing precision therapies for genetically defined paediatric and adult cancers. Focuses on RAF pathway inhibition with differentiated once-weekly oral dosing. Wholly owned approved asset with Phase 2 expansion into additional indications.
 

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