Exkivity

Q: What is an accelerated FDA approval?

The [FDA Accelerated Approval Program](https://www.goodrx.com/drugs/medication-basics/fda-accelerated-approval) allows a medication to be approved faster than usual if the medication helps fill an unmet medical need and if it treats a serious condition. These approvals are based on a surrogate endpoint, which is a marker (sign) that's believed to predict a clinical benefit. For example, tumor shrinkage is a surrogate endpoint for cancer survival. After a medication receives accelerated approval, the manufacturer is still required to complete additional studies to make sure the treatment is beneficial. Otherwise, it's possible the medication could lose its approval status and be taken off the market.

Q: What is Exkivity (mobocertinib) used for?

Exkivity (mobocertinib) is used to treat adults with advanced NSCLC with a specific mutation (change in DNA) called [EGFR exon 20 insertion mutations](https://tcr.amegroups.com/article/view/37726/html). You can find out if you have this mutation through an [FDA-approved genetic test](https://www.fda.gov/medical-devices/recently-approved-devices/oncominetm-dx-target-test-p160045s019) that your provider will order for you. Exkivity (mobocertinib) should only be used if your condition wasn't treated successfully with a first-choice treatment option, such as [carboplatin](https://www.goodrx.com/carboplatin/what-is) or [cisplatin-based](https://www.goodrx.com/cisplatin/what-is) treatments.

Q: What are some of the risks and warnings for Exkivity (mobocertinib)?

Exkivity (mobocertinib) can cause serious heart problems, including abnormal heart rhythm and heart failure, which can be deadly. If you experience heart palpitations (racing heart), dizziness, trouble breathing, or lightheadedness, let your provider know right away. Diarrhea is a common side effect of this medication, but occasionally, it can be severe. Make sure you stay hydrated and talk to your provider if diarrhea occurs. In addition, Exkivity (mobocertinib) can cause scarring of your lungs, which can lead to lung damage. Call your provider right away if you have a new or worsening cough, trouble breathing, or chest pain.

mobocertinib

Used for Lung Cancer

Exkivity (mobocertinib) is used to treat a specific type of advanced non-small cell lung cancer (NSCLC) in adults. It was given accelerated approval and is the first FDA-approved medication for this condition that's available in a convenient oral capsule. But the medication should only be used if first-choice treatments haven't worked. Side effects include diarrhea, vomiting, and rash.

Note: Exkivity (mobocertinib) is no longer available in the United States as the manufacturer as voluntarily withdrawn it from the market.

Reviewed by:

Daisy Chau, PharmD

Ashley Wong, PharmD

Last reviewed on November 2, 2021

What is Exkivity (mobocertinib)?

What is Exkivity (mobocertinib) used for?

Locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations in people who have previously had chemotherapy

How Exkivity (mobocertinib) works

Exkivity (mobocertinib) works by blocking tyrosine kinases in cancer cells. Tyrosine kinases are proteins that tell cancer cells to grow and divide. By stopping these proteins, Exkivity (mobocertinib) helps treat NSCLC by aiming to slow down cancer growth.

Drug facts

Common Brands	Exkivity
Drug Class	Tyrosine kinase inhibitor
Controlled Substance Classification	Not a controlled medication
Generic Status	No lower-cost generic available
Availability	Discontinued

Common Brands

Exkivity

Drug Class

Tyrosine kinase inhibitor

Controlled Substance Classification

Not a controlled medication

Generic Status

No lower-cost generic available

Availability

Discontinued

Side effects of Exkivity (mobocertinib)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Diarrhea (92%)
Skin rash (78%)
Mouth sores (46%)
Vomiting (40%)
Loss of appetite (39%)
Fingernail and toenail infections (39%)
Nausea (37%)
Muscle or bone pain (34%)
Dry skin (32%)
Fatigue (29%)
Itchiness (24%)
Cough (24%)
Weight loss (21%)

Less Common Side Effects

Stomach pain
Acid reflux
Indigestion
Hair loss
Upper respiratory tract infection
Trouble breathing
Runny nose
Vision problems
Headache
High blood pressure

Exkivity (mobocertinib) serious side effects

Contact your healthcare provider immediately if you experience any of the following.

Abnormal heart rhythm: lightheadedness, dizziness, feeling faint
Heart failure: shortness of breath, cough or wheezing, fast heart rate, swelling (edema), weight gain
Lung damage: cough, trouble breathing, chest pain
Severe diarrhea

Source: DailyMed

Common questions about Exkivity

The FDA Accelerated Approval Program allows a medication to be approved faster than usual if the medication helps fill an unmet medical need and if it treats a serious condition. These approvals are based on a surrogate endpoint, which is a marker (sign) that's believed to predict a clinical benefit. For example, tumor shrinkage is a surrogate endpoint for cancer survival. After a medication receives accelerated approval, the manufacturer is still required to complete additional studies to make sure the treatment is beneficial. Otherwise, it's possible the medication could lose its approval status and be taken off the market.

Exkivity is used to treat adults with advanced NSCLC with a specific mutation (change in DNA) called EGFR exon 20 insertion mutations. You can find out if you have this mutation through an FDA-approved genetic test that your provider will order for you. Exkivity should only be used if your condition wasn't treated successfully with a first-choice treatment option, such as carboplatin or cisplatin-based treatments.

The typical starting dose is 160 mg (4 capsules) by mouth once daily with or without food. Your dose might be lowered if you experience certain side effects or if you're taking certain medications.

Exkivity can cause serious heart problems, including abnormal heart rhythm and heart failure, which can be deadly. If you experience heart palpitations (racing heart), dizziness, trouble breathing, or lightheadedness, let your provider know right away. Diarrhea is a common side effect of this medication, but occasionally, it can be severe. Make sure you stay hydrated and talk to your provider if diarrhea occurs. In addition, Exkivity can cause scarring of your lungs, which can lead to lung damage. Call your provider right away if you have a new or worsening cough, trouble breathing, or chest pain.