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

Breslyn, lives with pLGG, and Noelle, her sister

Tumor response with OJEMDA

pLGG tumor shrinkage may be possible with once-weekly oral OJEMDA

Meaningful tumor shrinkage

0%

saw their tumors shrink by at least 25%

(39 out of 76 children)

  • 37% (28 out of 76 children) had tumor shrinkage of 50% or more
  • No child had their tumor completely disappear

Additional results

0%

(43 out of 76 children)

of children either experienced tumor shrinkage by at least 25% or had a stable tumor size for 12 months or more*

0%

(62 out of 76 children)

of children either experienced tumor shrinkage by at least 25% or had a stable tumor size for 3 months or more*

These additional data were collected during the clinical study, and additional analyses were done. These results are not in the OJEMDA Prescribing Information.

*Stability was defined as the tumor not growing or shrinking more than 25%.

When were results measured?*

Results were measured with MRI scans every 3 months:

46% (18 out of 39) saw tumor shrinkage on their MRI scan at 3 months after starting treatment. 77% (30 out of 39) saw tumor shrinkage on their MRI scan at 6 months after starting treatment

*These data were collected during the clinical study, and additional analyses were done. These results are not in the OJEMDA Prescribing Information.

How long did children maintain tumor shrinkage?

74% of children (102 out of 137) were still taking OJEMDA at the time of study evaluation on June 5, 2023.

At the time of review, half of the children who saw tumor shrinkage saw it for 13.8 months.

FIREFLY-1 is an ongoing trial and will conclude by end of 2024.

Learn about safety and side effects of OJEMDA

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IMPORTANT SAFETY
INFORMATION

Before taking or giving OJEMDA, tell your healthcare provider about all of your or your child’s medical conditions, including if you:

  • have bleeding, skin, or liver problems
  • are pregnant or plan to become pregnant. OJEMDA can harm your unborn baby.

Females who are able to become pregnant:

  • You should use effective non-hormonal birth control (contraception) during treatment with OJEMDA and for 28 days after your last dose of OJEMDA.

Males with female partners who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment with OJEMDA and for 2 weeks after your last dose of OJEMDA.

  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose of OJEMDA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking OJEMDA?

Limit the amount of time you spend in sunlight. OJEMDA can make your skin sensitive to the sun (photosensitivity). Use sun protection measures, such as sunscreen, sunglasses and wear protective clothes that cover your skin during your treatment with OJEMDA.

What are the possible side effects of OJEMDA?

OJEMDA may cause serious side effects, including:

  • bleeding problems (hemorrhage) are common and can also be serious. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:
    • headache, dizziness or feeling weak
    • coughing up blood or blood clots
    • vomiting blood or your vomit looks like "coffee grounds"
    • red or black stools that look like tar
  • skin reactions, including sensitivity to sunlight (photosensitivity). OJEMDA can cause skin reactions that can become severe. Tell your healthcare provider if you get new or worsening skin reactions, including:
    • rash
    • bumps or tiny papules
    • acne
    • peeling, redness, or irritation
    • blisters
  • liver problems. Your healthcare provider will do blood tests to check your liver function before and during treatment with OJEMDA. Tell your healthcare provider right away if you develop any of the following symptoms:
    • yellowing of your skin or your eyes
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite
    • tiredness
    • bruising
    • bleeding
    • pain in your upper right stomach area
  • slowed growth in children. Growth will be checked routinely during treatment with OJEMDA.

The most common side effects of OJEMDA include:

  • rash
  • hair color changes
  • tiredness
  • viral infection
  • vomiting
  • headache
  • fever
  • dry skin
  • constipation
  • nausea
  • acne
  • upper respiratory tract infection

OJEMDA may cause fertility problems in males and females, which may affect your ability to have children.

INDICATION

What is OJEMDA™ (tovorafenib)?

OJEMDA is a prescription medicine used to treat certain types of brain tumors (cancers) called gliomas in patients 6 months and older:

  • that is a pediatric low-grade glioma (LGG), and
  • that has come back after previous treatment or has not responded to previous treatment and
  • that has a certain type of abnormal “BRAF” gene.

These are not all the possible side effects of OJEMDA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Patient Information, including Instructions for Use, for more information.