What is the name of the drug and what does it do?
Voranigo (vo-rah-NEE-goh), generic name vorasidenib approved on August 6 2024, is a medicine used to treat certain types of brain tumors called Grade 2 astrocytoma and oligodendroglioma.
These tumors must have a specific mutation in the IDH1 or IDH2 genes. It is prescribed for people aged 12 and older after surgery, such as a biopsy or tumor removal.
How does it work?
Voranigo blocks two enzymes, IDH1 and IDH2, that are often mutated in these brain tumors. When these enzymes are mutated, they produce a harmful molecule called 2-hydroxyglutarate, which interferes with normal cell functions. By stopping these enzymes, Voranigo helps slow tumor growth and lets cells behave more normally.
What did the research discover?
Studies found that Voranigo helps patients go longer without their tumors growing or needing more cancer treatment. In a clinical trial with 331 people, those taking Voranigo had a 61% lower risk of their cancer getting worse compared to those who took a placebo. The treatment was well tolerated by most patients.
What are some of the side effects?
The most common side effects include feeling tired, headaches, muscle pain, diarrhea, nausea, and seizures. Some patients had higher levels of liver enzymes, which can indicate liver problems. Serious liver issues are rare, but patients should watch for yellow skin or eyes, dark urine, or stomach pain and tell their doctor if these happen.
What are the dosage recommendations and how is it prescribed?
The usual dose for adults and kids who weigh 88 pounds (40 kilograms) or more is 40 mg once daily. For kids weighing less than 88 pounds, the dose is 20 mg daily. The tablets should be swallowed whole with water and can be taken with or without food. It’s important to take the medicine at the same time each day. If you miss a dose by more than six hours, skip it and take your next dose as scheduled.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 218784]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Accessed 2024 Nov 20.
