*VORANIGO helped people live longer without their tumor growing.
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How VORANIGO is studied
Results
Extended results
How was VORANIGO studied?
VORANIGO was studied in the INDIGO trial. This clinical trial compared people treated with VORANIGO with people treated with placebo. The placebo group was used to help compare what results would be for people who choose to be on active observation compared to those who take VORANIGO after they are diagnosed with IDH-mutant glioma.
IN THE INDIGO TRIAL, VORANIGO WAS SHOWN TO
increase the length of time a person can live progression free
WITH GRADE 2 IDH-MUTANT Astrocytoma OR Oligodendroglioma.
Living progression free means living without significant tumor growth.
PROGRESSION-FREE SURVIVAL
(PFS)
aThe median follow-up was 14 months with VORANIGO and 14.3 months with placebo.
b2 years after starting placebo, 3 out of 10 patients did not require additional treatment.
TIME TO NEXT INTERVENTION
(TTNI)
SEE
Rob’s story
See how VORANIGO helped Rob on his journey with IDH-mutant oligodendroglioma.
Watch now
CHANGES IN TUMOR SIZE
with VORANIGO vs placebo
An additional analysis from the INDIGO clinical trial studied how VORANIGO affected the growth of tumors over time compared to placebo. The results below show a change in tumor size for people in the trial.
Tumor growth rate was not the main goal of the study. Tumor growth rate is not a proven way to measure the treatment effects of VORANIGO, and it is unknown if these changes translate to measurable benefits for patients. It’s important to keep this in mind when looking at these data.
SEIZURE ACTIVITY
with VORANIGO
In the INDIGO trial, seizures were one of the most common side effects reported on VORANIGO.
Only patients who reported at least 1 seizure during the INDIGO trial were included in the seizure activity analysis. Seizure activity was recorded using patient diaries, which patients used to document any seizures they experienced throughout the trial.
Seizure data should be interpreted with caution. It is important to keep in mind that understanding changes in seizure activity was not the main goal of the clinical trial.
If you have any questions about how this may apply to your care plan, please speak with your doctor.
Do not stop taking your medication or change the way you take your medication without speaking to your doctor. Always report changes in your seizure activity to your doctor.
Act and treat WITH VORANIGO
Start a conversation with your healthcare provider using the helpful questions in the VORANIGO Doctor Discussion Guide.
VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.
What are the possible side effects of VORANIGO?
VORANIGO may cause serious side effects, including:
Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
yellowing of your skin or the white part of your eyes (jaundice)
dark tea-colored urine
loss of appetite
pain on the upper right side of your stomach area
feeling very tired or weak
What is VORANIGO?
VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.
What are the possible side effects of VORANIGO?
VORANIGO may cause serious side effects, including:
Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
yellowing of your skin or the white part of your eyes (jaundice)
dark tea-colored urine
loss of appetite
pain on the upper right side of your stomach area
feeling very tired or weak
The most common side effects of VORANIGO include:
increased liver enzyme levels in the blood
lack of energy, tiredness
headache
COVID-19
muscle aches or stiffness
diarrhea
nausea
seizure
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VORANIGO if you have certain side effects.
VORANIGO may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of VORANIGO.
Before taking VORANIGO, tell your healthcare provider about all of your medical conditions, including if you:
have liver problems
have kidney problems or are on dialysis
smoke tobacco
are pregnant or plan to become pregnant. VORANIGO can harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider will do a pregnancy test before you start treatment with VORANIGO
You should use effective nonhormonal birth control during treatment with VORANIGO and for 3 months after the last dose. VORANIGO may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VORANIGO
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VORANIGO
Males with female partners who are able to become pregnant:
You should use effective birth control during treatment with VORANIGO and for 3 months after the last dose
Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with VORANIGO
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VORANIGO passes into breast milk. Do not breastfeed during treatment with VORANIGO and for 2 months after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VORANIGO may affect the way other medicines work, and other medicines may affect how VORANIGO works.
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