Ojemda Offers a Breakthrough Option for Pediatric Low-Grade Glioma

Dec 26, 2025

What is it prescribed for?

OJEMDA, approved on April 23, 2024, is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric lowgrade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 

What is the name of the drug and what does it do?

Ojemda (pronounced oh-JEM-dah), (generic name: tovorafenib), is a medication 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.

How does it work?

Ojemda is a kinase inhibitor. It works by blocking specific enzymes known as RAF kinases that promote cancer cell growth.

 By inhibiting these kinases, Ojemda helps to slow or stop the growth of cancer cells in patients with LGG that have certain BRAF mutations.

What did the research discover?

Clinical trials have shown that Ojemda is effective in treating relapsed or refractory pediatric low-grade glioma. 

The studies demonstrated that patients treated with Ojemda had a significant overall response rate, with many patients experiencing tumor shrinkage and prolonged periods without disease progression. 

These promising results were based on the response rate and duration of response, leading to accelerated approval of the drug.

What are some of the side effects?

  • Rash
  • Hair color changes
  • Fatigue
  • Viral infection
  • Vomiting
  • Headache
  • Hemorrhage
  • Pyrexia (fever)
  • Dry skin
  • Constipation
  • Nausea
  • Dermatitis acneiform (acne-like skin condition)
  • Upper respiratory tract infection

What are the dosage recommendations and how is it prescribed?

Ojemda is administered orally once weekly, with the dosage based on body surface area. It is available in tablet form or as an oral suspension. 

The recommended dosage ranges from 380 mg/m² to a maximum of 600 mg once weekly. Patients should swallow the tablets whole with water without chewing, cutting, or crushing them. 

For the oral suspension, it should be prepared and administered according to specific instructions provided by healthcare providers.

Source:

  • Day One Biopharmaceuticals Inc. Ojemda (tovorafenib) tablets and oral suspension, for oral use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf

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