ExkivityTM (mobocertinib) is a drug used to treat adults with non-small cell lung cancer (NSCLC) that:1
- Has spread to other parts of the body (metastatic) or is locally advanced (cancer has progressed within the lung region), and
- Has epidermal growth factor receptor (EGFR) exon 20 insertion mutations, and
- Has worsened while on or after receiving platinum-based chemotherapy
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Exkivity in September 2021. The FDA may give accelerated approval to new drugs that treat a health condition that has few or no other treatments. This means drugs like Exkivity can be made available sooner. However, they typically require ongoing studies to confirm the benefits of the drug.1
Exkivity is the first oral therapy designed to target EGFR exon 20 insertions. Your doctor will give you a test to make sure Exkivity is right for you.1
NSCLC makes up about 80 to 85 percent of all lung cancers. About 2 to 3 percent of people with NSCLC have EGFR exon 20 insertion mutations. These mutations allow the cancer to grow and spread.2
What are the ingredients in Exkivity?
The active ingredient in Exkivity is mobocertinib.1,3
How does Exkivity work?
Exkivity is a type of drug known as a kinase inhibitor. Kinases are enzymes in the body that help control many cell functions. Certain kinases help cancer cells grow and survive. Kinase inhibitors like Exkivity can block tumor growth.3,4
What are the possible side effects?
The most common side effects of Exkivity include:2
- Nausea, vomiting, and diarrhea
- Decreased appetite
- Rash
- Mouth sores
- Tiredness
- Dry skin
- Muscle and bone pain
- Infection of skin around the nails
Exkivity may also cause serious side effects, including:3
- Lung problems
- Heart problems, including heart failure
- Severe diarrhea
Exkivity has a boxed warning, the strictest warning from the FDA. It has this warning because Exkivity can cause serious and life-threatening changes in the electrical activity of your heart. These changes are called QTc prolongation and Torsades de Pointes. Your doctor will monitor you before and during treatment with Exkivity. While taking Exkivity, you should not take drugs that can affect the QTc interval or interact with enzymes called CYP3A. If QTc prolongation occurs, your doctor may temporarily stop Exkivity and may lower the dose when re-starting treatment. Or, your doctor may permanently stop treatment with this drug.1,3
These are not all the possible side effects of Exkivity. Talk to your doctor about what to expect when taking Exkivity. You should also call your doctor if you have any changes that concern you when taking Exkivity.
Other things to know
Avoid eating grapefruit or drinking grapefruit juice while taking Exkivity. Grapefruit may increase the levels of Exkivity in your body, which can increase the risk of side effects.3
Before taking Exkivity, tell your doctor if you have:3
- Heart problems, including long QTc syndrome
- Electrolyte problems, such as issues with sodium, potassium, calcium, or magnesium levels
- Lung or breathing problems aside from lung cancer
Exkivity can harm an unborn baby. If you or your partner can become pregnant, you should use birth control during treatment and for some time after the last dose of Exkivity. You should also not breastfeed during treatment with Exkivity and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Exkivity.3
Before beginning treatment for lung cancer, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Exkivity.