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OJEMDA (tovorafenib) logo: 100 mg tablets 25 mg/mL for oral suspension

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Prescribing Information

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OJEMDA + pLGG

About pLGG

pLGG is predominantly driven by genomic alterations in the MAPK pathway1,2

Activating BRAF alterations (fusions or mutations) are the most common oncogenic drivers of pLGG2

Up to

0%

of patients with pLGG have BRAF alterations2‑7

Incidence varies by pLGG subtype.

~0%

of these cases have BRAF fusions, primarilyKIAA1549-BRAF

Predominantly seen in pilocytic astrocytomas.

~20%

of these cases have BRAF point mutations, primarily BRAF V600E

May vary across pLGG subtypes.

Type I BRAF inhibitors only target BRAF point mutations8

  • First-generation, BRAF-targeted therapies, also known as type I BRAF inhibitors, are designed to address only BRAF V600E point mutations
  • Type I BRAF inhibitors cannot inhibit signaling from BRAF fusions and have been shown to cause tumor growth (paradoxical activation)

Not all BRAF inhibitors are designed to target both BRAF fusions and BRAF point mutations8

Mechanism of Action

OJEMDA: First and only type II RAF inhibitor for BRAF fusions or rearrangements, or BRAF V600 mutations9

Unlike type I BRAF inhibitors, OJEMDA can inhibit signaling fromBRAF fusions8,9

OJEMDA inhibits BRAF fusions or rearrangements as well as BRAF V600E mutations, resulting in inhibited tumor proliferation and survival

Tovorafenib inhibits MAPK signaling without promoting tumor cell growth8,9

BRAF=v-Raf murine sarcoma viral oncogene homolog B1; ERK=extracellular signal-regulated kinase; MAPK=mitogen-activated protein kinase; MEK=mitogen-activated protein kinase kinase; pLGG=pediatric low-grade glioma; RAF=rapidly accelerated fibrosarcoma.

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IMPORTANT SAFETY INFORMATION
INDICATION

Warnings and Precautions

Hemorrhage

Hemorrhage, including major hemorrhage defined as symptomatic bleeding in a critical area or organ, can occur with OJEMDA. Advise patients and caregivers of the risk of hemorrhage during treatment with OJEMDA. Monitor for signs and symptoms of hemorrhage and evaluate as clinically indicated. Withhold and resume at reduced dose upon improvement, or permanently discontinue based on severity.

Skin Toxicity Including Photosensitivity

OJEMDA can cause rash, including maculopapular rash and photosensitivity. Monitor for new or worsening skin reactions. Consider dermatologic consultation and initiate supportive care as clinically indicated. Withhold, reduce the dose, or permanently discontinue OJEMDA based on severity of adverse reaction.

Photosensitivity

Advise patients to use precautionary measures against ultraviolet exposure such as use of sunscreen, sunglasses, and/or protective clothing during treatment with OJEMDA. Withhold, reduce the dose, or permanently discontinue OJEMDA based on severity of adverse reaction.

Hepatotoxicity

OJEMDA can cause hepatotoxicity. Monitor liver function tests, including ALT, AST and bilirubin, before initiation of OJEMDA, one month after initiation and then every three months thereafter and as clinically indicated. Withhold and resume at the same or reduced dose upon improvement, or permanently discontinue OJEMDA based on the severity.

Effect on Growth

OJEMDA can cause reductions in growth velocity. Growth velocity improved after interruption of treatment with OJEMDA. Routinely monitor patient growth during treatment with OJEMDA.

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, OJEMDA may cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 28 days after the last dose, since OJEMDA can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 2 weeks after the last dose.

NF1 Associated Tumors

Based on nonclinical data in NF1 models without BRAF alterations, tovorafenib may promote tumor growth in patients with NF1 tumors. Confirm evidence of a BRAF alteration prior to initiation of treatment with OJEMDA.

Adverse Reactions

The most common adverse reactions (≥30%) were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection.

INDICATION

OJEMDATM (tovorafenib) 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information.

References