Tovorafenib (1 brand name, 2 dosage forms, 1 route)
Available dosage forms: TABLET, FOR SUSPENSION.
Routes of administration: ORAL.
Brand Names
- OJEMDA
Indications and Usage
OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.1)] Skin Toxicity Including Photosensitivity [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Effect on Growth [see Warnings and Precautions (5.4)]
Mechanism of Action
Tovorafenib is a Type II RAF kinase inhibitor of mutant BRAF V600E, wild-type BRAF, and wild-type CRAF kinases. Tovorafenib exhibited antitumor activity in cultured cells and xenograft tumor models harboring BRAF V600E and V600D mutations, and in a xenograft model harboring a BRAF fusion.