Useful information about MODEYSO
Get answers to some commonly asked questions and find definitions of some key terms
Useful information about MODEYSO
Get answers to some commonly asked questions and find definitions of some key terms
FAQs
Answers to some of your questions
Questions about H3 K27M–mutant diffuse midline glioma and MODEYSO
“H3 K27M” describes a specific mutation that is seen in some patients with glioma. “H3” refers to the protein histone H3, which is affected by the mutation. “K27M” refers to the change in the amino acid sequence of histone H3 that occurs due to the mutation. Specifically, the lysine (“K”) that is typically found at the 27th position has been replaced with methionine (“M”), which is summarized as “K27M.”
Learn more about H3 K27M–mutant diffuse midline glioma.
“H3 K27M” describes a specific mutation that is seen in some patients with glioma. “H3” refers to the protein histone H3, which is affected by the mutation. “K27M” refers to the change in the amino acid sequence of histone H3 that occurs due to the mutation. Specifically, the lysine (“K”) that is typically found at the 27th position has been replaced with methionine (“M”), which is summarized as “K27M.”
Learn more about H3 K27M–mutant diffuse midline glioma.
MODEYSO has been studied in isolated cells from H3 K27M–mutant diffuse glioma and may reverse a chemical process caused by the mutation.
Discover more about how MODEYSO works.
MODEYSO has been studied in isolated cells from H3 K27M–mutant diffuse glioma and may reverse a chemical process caused by the mutation.
Discover more about how MODEYSO works.
Questions about how MODEYSO was approved and who it is for
The FDA created the Accelerated Approval Program to allow for earlier approval of needed treatments for serious conditions. MODEYSO received accelerated approval based on the overall response rate and duration of response and results demonstrating treatment safety. Continued approval may depend on further studies, which will continue to explore the clinical benefits and safety of MODEYSO.
Learn more about MODEYSO clinical studies.
The FDA created the Accelerated Approval Program to allow for earlier approval of needed treatments for serious conditions. MODEYSO received accelerated approval based on the overall response rate and duration of response and results demonstrating treatment safety. Continued approval may depend on further studies, which will continue to explore the clinical benefits and safety of MODEYSO.
Learn more about MODEYSO clinical studies.
MODEYSO is a prescription medicine used to treat certain types of brain tumors called H3 K27M–mutant diffuse midline gliomas in adults and children 1 year of age and older. It is specifically for people with tumors that meet the following criteria: identified as diffuse midline gliomas, have grown or come back after trying other treatments, and have a specific H3 K27M gene mutation. Your doctor will determine if MODEYSO is right for you or the person you care for. MODEYSO is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of MODEYSO for this use.
Discover how MODEYSO works.
MODEYSO is a prescription medicine used to treat certain types of brain tumors called H3 K27M–mutant diffuse midline gliomas in adults and children 1 year of age and older. It is specifically for people with tumors that meet the following criteria: identified as diffuse midline gliomas, have grown or come back after trying other treatments, and have a specific H3 K27M gene mutation. Your doctor will determine if MODEYSO is right for you or the person you care for. MODEYSO is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of MODEYSO for this use.
Discover how MODEYSO works.
Children who are 1 year of age and older with certain types of brain tumors called H3 K27M–mutant diffuse midline gliomas who weigh at least 22 pounds (10 kg) may be eligible to receive MODEYSO. It is specifically for adults and children with tumors that meet the following criteria: identified as diffuse midline gliomas, have grown or come back after trying other treatments, and have a specific H3 K27M gene mutation. Your child's doctor will determine if MODEYSO is right for your child.
Learn how to get started on MODEYSO.
Children who are 1 year of age and older with certain types of brain tumors called H3 K27M–mutant diffuse midline gliomas who weigh at least 22 pounds (10 kg) may be eligible to receive MODEYSO. It is specifically for adults and children with tumors that meet the following criteria: identified as diffuse midline gliomas, have grown or come back after trying other treatments, and have a specific H3 K27M gene mutation. Your child's doctor will determine if MODEYSO is right for your child.
Learn how to get started on MODEYSO.
Questions about taking MODEYSO
MODEYSO should be taken by mouth once weekly and can be taken anywhere. Capsules of MODEYSO, or their contents dissolved in liquid, should be swallowed. MODEYSO should be taken on an empty stomach, 1 hour before or 3 hours after a meal. Review the Instructions for Use for MODEYSO with your doctor before getting started.
Learn more about how to take MODEYSO.
MODEYSO should be taken by mouth once weekly and can be taken anywhere. Capsules of MODEYSO, or their contents dissolved in liquid, should be swallowed. MODEYSO should be taken on an empty stomach, 1 hour before or 3 hours after a meal. Review the Instructions for Use for MODEYSO with your doctor before getting started.
Learn more about how to take MODEYSO.
A dose of MODEYSO is taken once per week. The full dose should always be taken on the same day of the week. Establishing a routine may help to keep dosing on schedule.
Learn more about how to take MODEYSO.
A dose of MODEYSO is taken once per week. The full dose should always be taken on the same day of the week. Establishing a routine may help to keep dosing on schedule.
Learn more about how to take MODEYSO.
Side effects, also known as adverse reactions, are possible with MODEYSO. The most common adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. These are not all of the possible side effects of MODEYSO.
Review the safety profile for MODEYSO.
Side effects, also known as adverse reactions, are possible with MODEYSO. The most common adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. These are not all of the possible side effects of MODEYSO.
Review the safety profile for MODEYSO.
There are many foundations in the United States that can provide support.
There are many foundations in the United States that can provide support.
DIPG, diffuse intrinsic pontine glioma; FDA, US Food and Drug Administration.
If you have any other questions, reach out to your doctor or the healthcare team of the person you care for
Glossary
Your guide to some important terms
Amino acid: The basic structural unit (building block) of a protein.
Diffuse glioma: A type of glioma that doesn’t have a clear edge.
Glia: A type of cell found in the brain and spine.
Glioma: A type of brain tumor that originates from glial cells.
Histone: A type of protein found in chromosomes that binds to deoxyribonucleic acid (DNA).
Immunohistochemistry: A laboratory test used to find proteins in tissue samples.
Methylation: A process where a molecule called a “methyl” group is added to a protein.
Midline glioma: A glioma in the middle part of the brain and spinal cord.
Mutation: A change in DNA that can affect the way a cell works.
Next-generation sequencing: A technology that can detect mutations in the order of the units in a DNA strand.
Targeted therapy: A therapy that acts on a specific protein or mutation related to a particular disease.