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🏅 FDA Orphan Designation

Ojemda

tovorafenib

Manufacturer: Day One Biopharmaceuticals, Inc.

Indicated for:
Pilocytic astrocytomaOrphan

FDA-Approved Indications (1)

Pilocytic astrocytomaOrphan Designation

Treatment of pediatric patients 6 months of age and older and young adults with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement.

Indications & Usage

1 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). OJEMDA is a kinase inhibitor 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. ( 1 ) 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).

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.