Ojemda: New Drug Approved for Pediatric Brain Tumors
Swissmedic Grants Temporary Authorization for Tovorafenib
The regulatory authority Swissmedic has approved Ojemda (active ingredient Tovorafenib) in Switzerland. The drug is intended for children aged six months and older with pediatric low-grade glioma, a rare type of brain tumor. The authorization is temporary and was granted on May 5, 2026, as stated in the summary report dated August 25, 2026.
Authorization for Children with Low-Grade Glioma
Ojemda is used in patients with pediatric low-grade glioma that has a BRAF alteration. This includes BRAF fusions, BRAF rearrangements, or BRAF mutations. The tumor must have recurred or progressed after prior therapy. The active ingredient Tovorafenib specifically targets the continuously activated growth signals of tumor cells.
Efficacy was investigated in the single-arm FIREFLY-1 study. A total of 137 patients participated. Ages ranged from six months to 25 years. The medication is taken once per week.
Mechanism of Action and Dosage Forms
Ojemda is available as a powder for oral suspension and as film-coated tablets. “The treatment should be initiated and supervised by healthcare professionals experienced in treating cancer,” Swissmedic states.
The medicine is administered orally. Dosage is based on body weight. Switching between the two dosage forms is possible according to the instructions in the prescribing information.
Temporary Authorization as an Orphan Drug
“Because it is a rare and life-threatening or chronically debilitating disease, Ojemda was approved as a so-called ‘Orphan Drug’,” Swissmedic writes in the summary report. This classification applies to medicines for rare diseases for which few treatment options currently exist.
Among other things, details regarding costs, reimbursement, and the specific conditions of the temporary authorization remain open following the summary report. Further information can be found in the public summary report from Swissmedic.
Sources
- Summary Report Authorization – Ojemda® (Primary source, 2026-08-25, researched on 2026-08-26)
