Name: Tovorafenib (DAY101) in RAF-altered pediatric low-grade glioma requiring first-line systemic therapy: Special populations
Published: 2026-09-17T18:16:08-04:00

Pediatric use and age limits

“The safety and effectiveness of OJEMDA in patients younger than 6 months of age have not been established.” (opens the source at this quote in a new tab)
“Of these 137 patients, 2% (n=3) were 6 month to < 2 years of age, 67% (n=92) were 2 years to < 12 years of age, and 31% (n=42) were >12 years of age” (opens the source at this quote in a new tab)

“Tovorafenib paediatric clinical experience is limited, particularly in the specific age range 6 months to 2 years.” (opens the source at this quote in a new tab)
“The MAH shall generate additional PK data in paediatrics patients below 2 years of age and submit an updated population PK model incorporating these data, including an assessment of systemic exposure and, if necessary, revised dosing recommendations for this subgroup of patients.” (opens the source at this quote in a new tab)

Small body surface area

“A recommended dosage for patients with BSA less than 0.3 m 2 has not been established.” (opens the source at this quote in a new tab)

First-line pLGG: age range in FIREFLY-2

“Less than 25 years of age with LGG with known activating RAF alteration.” (opens the source at this quote in a new tab)

Hepatic impairment

“No dose adjustment is recommended for patients with mild (bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or bilirubin > 1× to 1.5× ULN and any AST) hepatic impairment. OJEMDA has not been studied in patients with moderate (bilirubin > 1.5× to 3× ULN and any AST) to severe (bilirubin > 3× ULN and any AST) hepatic impairment” (opens the source at this quote in a new tab)

“Patients with moderately or severely abnormal liver function tests should be monitored carefully when treated with tovorafenib.” (opens the source at this quote in a new tab)

“Despite liver being the primary route of elimination of tovorafenib, no dedicated study in patients with hepatic impairment (HI) was conducted.” (opens the source at this quote in a new tab)

Renal impairment

“No dose adjustment is recommended for patients with mild-to-moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m 2 calculated by Schwartz equation or MDRD equation). OJEMDA has not been studied in patients with severe renal impairment (eGFR <30 mL/min/1.73 m 2 )” (opens the source at this quote in a new tab)

Age, sex, and race

“No clinically significant differences of tovorafenib were observed based on age (range: 1 to 94 years), sex, race (White, Black, Asian), mild hepatic impairment” (opens the source at this quote in a new tab)

Pregnancy

“There are no available data on the use of OJEMDA in pregnant women. Oral administration of tovorafenib to pregnant rats during the period of organogenesis resulted in embryo lethality at exposures 0.8 times the human exposure at the recommended dose based on AUC” (opens the source at this quote in a new tab)

“Tovorafenib should not be administered to pregnant women unless the potential benefit to the mother outweighs the possible risk to the foetus.” (opens the source at this quote in a new tab)

Lactation

“There are no data on the presence of tovorafenib or its metabolites in human milk, their effects on the breastfed child, or on milk production. Due to the potential for serious adverse reactions in breastfed children from OJEMDA, advise lactating women not to breastfeed during treatment with OJEMDA and for 2 weeks following the last dose.” (opens the source at this quote in a new tab)

Females and males of reproductive potential: pregnancy testing and contraception

“Verify pregnancy status in females of reproductive potential prior to initiating OJEMDA” (opens the source at this quote in a new tab)
“Advise females of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 28 days after the last dose. OJEMDA can render hormonal contraceptives ineffective” (opens the source at this quote in a new tab)
“Advise male patients with female partners of reproductive potential to use effective contraception during treatment with OJEMDA and for 2 weeks after the last dose.” (opens the source at this quote in a new tab)

“Male patients with female partners of reproductive potential must use condoms and effective methods of contraception during treatment with tovorafenib and for 2 weeks after the last dose.” (opens the source at this quote in a new tab)

Fertility

“There are no data on the effects of tovorafenib on fertility in humans. Based on findings in animals, tovorafenib may impact fertility in males and females of reproductive potential and may not be reversible (see section 5.3).” (opens the source at this quote in a new tab)

Neurofibromatosis type 1

“Patients with tumors harboring additional activating molecular alteration(s) (e.g., IDH1/2 mutations, FGFR mutations, etc.) or patients with known or suspected diagnosis of neurofibromatosis type 1 (NF1) were excluded.” (opens the source at this quote in a new tab)

“Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).” (opens the source at this quote in a new tab)

Geriatric use

No evidence found.