Ojemda tovorafenib

Drug Class

Oral selective type II RAF kinase inhibitor

Mechanism

Selectively inhibits both monomeric and dimeric forms of RAF kinases (including BRAF V600 and BRAF fusions), blocking downstream MAPK cascade.

Approved Indication

FDA-approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

What This Means For Patients

Ojemda is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2024) — Sources

Pivotal Clinical Evidence

• FIREFLY-1 — Kilburn et al., Nat Med 2024 (NCT04775485) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-6-months-age-and-older-relapsed-or-refractory
• https://www.dayonebio.com/investors-media/