If you or a loved one has lung cancer, you may be looking into different treatment options. One new medicine you may hear about is Ensacove (ensartinib). In December 2024, the FDA approved Ensacove as a first-line treatment for non-small-cell lung cancer (NSCLC) in certain adults. NSCLC is the most common type of lung cancer.
Ensacove may also be used for other conditions. This article focuses on common questions and answers about Ensacove for NSCLC.
Is Ensacove Right for Me?
To see if Ensacove is right for you, your health care provider will consider things like the type of lung cancer you have and whether it has spread. They may take a tissue sample from your tumor (called a biopsy) for testing, do other blood tests, and review your medical history and any other medicines you take. They will also consider whether you have already tried other medicines to treat your lung cancer.
Ensacove is FDA-approved to treat non-small-cell lung cancer (NSCLC) in adults whose cancer meets all of the following requirements:
- ALK-positive, which means the cancer has certain abnormal proteins that tell the cancer cells to grow and multiply
- The cancer has spread to nearby tissues (locally advanced) or has spread to distant parts of your body (metastatic)
- Has not been treated with a medicine called an ALK-inhibitor in the past
Ensacove is only approved for use in adults. It is not known if this medicine is safe or effective for children.
How Does Ensacove Work for Non-Small-Cell Lung Cancer?
Ensacove belongs to a group of medicines called kinase inhibitors. Kinases are special proteins that help send and receive signals in your body. These signals help your cells do important jobs, such as growing properly. Some kinds of lung cancer cells have abnormal kinase proteins that make them grow and multiply faster than normal.
Ensacove is prescribed to treat NSCLC that has a specific type of abnormal protein called anaplastic lymphoma kinase (ALK). In some cancers, this protein is overactive, causing cells to grow and multiply too fast. Your health care provider can do tests to check for these proteins. If the results show your cancer is ALK-positive, they may recommend taking a medicine that targets ALK, such as Ensacove. By blocking the effects of ALK, Ensacove can help keep cancer cells from growing and may also help shrink tumors.
Are Any Other Medicines Available That Are Similar to Ensacove?
Ensacove is a newer medicine, but it is not the first one in its class. Crizotinib (Xalkori) was the first ALK inhibitor approved by the FDA for the treatment of ALK-positive non-small-cell lung cancer.
Examples of other ALK inhibitors include:
- Alectinib (Alecensa)
- Brigatinib (Alunbrig)
- Ceritinib (Zykadia)
- Crizotinib (Xalkori)
- Lorlatinib (Lorbrena)
To learn more about how Ensacove compares to crizotinib for this type of cancer, see the sections below about studies of Ensacove. To find out more about how Ensacove compares to other medicines, talk to your health care provider.
Is Ensacove a Type of Chemotherapy?
Ensacove is not a chemotherapy medicine. Chemotherapy medicines work by killing any type of fast-growing cells, even noncancerous ones, which can cause a lot of side effects.
Ensacove is a type of targeted therapy. It works by blocking a specific protein that helps certain cancer cells grow.
Even though Ensacove is designed to target cancer cells, it can still cause side effects. While the side effects of targeted therapies tend to be less common and less severe than the side effects of chemotherapy, serious side effects are still possible.
What Can I Do to Prevent or Manage Side Effects of Ensacove?
The list below includes some of the common side effects of Ensacove and possible ways to manage them. This is not a complete list of side effects. Tell your health care provider if these side effects bother you or do not go away. They may let you know about other ways to prevent or manage Ensacove side effects.
Skin rash or itchiness. To help prevent and manage skin rash and itchiness while taking Ensacove, avoid skin care products that contain fragrances. Choose mild, unscented soaps and moisturizers. Wear loose, soft clothing to avoid irritation and try not to scratch. For itch relief, try a cool cloth or an oatmeal soak. Your health care provider may also recommend medicines that you apply to your skin or take by mouth to help with skin itchiness or rash.
Muscle or joint pain. Ensacove may cause pain in your muscles, joints, or bones. Gentle stretches can help relieve aches and stiffness. Strategies such as physical therapy, acupuncture, or massage may be helpful in some cases. Your health care provider may also recommend pain medicines.
Constipation. To help prevent and manage constipation while taking Ensacove, make sure you are getting enough insoluble fiber in your diet. Examples of insoluble fiber are potatoes, almonds, walnuts, and seeds. If possible, getting more physical activity can also help, as the movement can stimulate your bowels. Your health care provider may also recommend laxative medicines or fiber supplements to help manage constipation.
Nausea or vomiting. Ensacove may cause nausea or vomiting. You can take Ensacove with or without food, but taking it with food may help to lessen nausea. When dealing with nausea, focus on staying hydrated. Sip cold, clear liquids like ginger ale, or let ice chips slowly melt in your mouth to avoid getting dehydrated. Eat small amounts of bland foods that are easy on the stomach, such as crackers or toast. Avoid strong smells and spicy or greasy foods. After meals, try to stay upright for at least an hour. If prescribed by your health care provider, take nausea medicine at the first sign of nausea.
Tiredness. To manage fatigue, stay as active as possible with activities like walking or yoga. Follow a daily routine, and focus on important tasks when you have the most energy. Get plenty of rest, aiming for seven to eight hours of sleep each night. Take short naps when needed, but too much napping can lower your energy even more. Eat a balanced diet and stay hydrated to support your body.
High blood sugar. Ensacove can increase blood sugar levels, which may lead to or worsen diabetes. Your health care provider may do blood tests to check for this side effect, and some people may need to check their blood sugar at home. You may need to take medicines or make diet changes to help manage your blood sugar levels. Tell your health care provider if you have symptoms of high blood sugar, such as feeling very hungry and thirsty, peeing more than usual, or feeling generally unwell, weak, or confused.
Too much uric acid in Your blood. Ensacove may increase the levels of uric acid in your blood. Your health care provider may do blood tests to watch for this side effect. They may also give you medicine to help lower uric acid levels. Tell your health care provider if you have symptoms of high uric acid, such as swelling and pain in your big toe or other joints, stomach pain, nausea or vomiting, or urine that looks pink or brown.
Ensacove may cause other, more serious side effects including allergic reactions. Tell your health care provider or get help right away if you have any of the following symptoms while taking Ensacove as these could be signs of serious side effects.
- Lung problems: Trouble breathing or cough that is worse than usual, chest pain, fever.
- Liver problems: Pain in your abdomen, dark urine, yellowish eyes or skin, loss of appetite, bleeding or bruising easily.
- Slow heartbeat: Dizziness, feeling lightheaded, fainting.
- Muscle problems: Muscle pain or weakness that does not go away.
- Vision problems: Blurred vision, double vision, seeing flashes of light or increased floaters.
How Do I Take Ensacove?
Ensacove comes as a capsule that you swallow whole. Do not crush, chew, or open Ensacove capsules. You can take this medicine with or without food.
The recommended dosage of Ensacove is 225 milligrams once daily. Consider setting an alarm to remind you to take it around the same time each day.
You will likely continue taking Ensacove for as long as the medicine is safe and effective for you. If you have certain side effects, your health care provider might pause your treatment or lower your dose to 200 milligrams or 150 milligrams once daily.
Ensacove capsules come in two strengths: 25 milligrams and 100 milligrams. So you will need to take more than one capsule to get the right dose. You can swallow the capsules together or one right after the next, at the same time each day. Follow the directions on your prescription label and be sure to take the correct number of capsules for each dose.
If you still have side effects after your dose is lowered, or if you have severe side effects or your cancer gets worse, your health care provider may tell you to stop taking Ensacove. Do not change your dosage or stop taking Ensacove on your own. Always ask your prescriber first.
How Was Ensacove Studied for Non-Small-Cell Lung Cancer?
The effectiveness of Ensacove was evaluated in a clinical trial called eXALT3. This trial involved 290 adults (149 males and 141 females), all of whom had ALK-positive non-small-cell lung cancer who had not been treated with an ALK-targeted medicine.
The median age of people in the studies was 54, meaning that half were younger and half were older. Their ages ranged from 25 to 90. The study took place across 120 centers in 21 countries. About 53.8%-57.1% of the people in the studies were Asian, 38.8%-44.1% were White, 0.7%-2% were Black or African American, and 2.1%-2.7% identified as other races or ethnicities. About 62% of the people in the studies were current smokers or smoked in the past, while around 38% never smoked.
In the study, people were randomly assigned to take either Ensacove or crizotinib (Xalkori).
The main goal of the trial was to measure how long people could live without their cancer getting worse, a measure called progression-free survival (PFS). The secondary goal was to see how long people lived overall, known as overall survival (OS).
What Are the Main Benefits of Ensacove Based on Studies?
The results of the eXALT3 study showed that Ensacove worked better than crizotinib in delaying the progression of cancer as measured by progression-free survival (PFS).
More specifically, the study found that people taking Ensacove lived 25.8 months without their cancer worsening, compared to 12.7 months for those taking crizotinib. This difference was considered statistically significant, meaning the results were likely not due to chance. People in the Ensacove group were less likely to have their cancer worsen during the study than those in the crizotinib group.
This study also looked at overall survival, which measured how long people lived after starting treatment. Of those who had been in the study for at least two years, there was no difference in overall survival between the people taking Ensacove and those taking crizotinib. This means that Ensacove did not reduce the risk of dying during the first two years when compared with crizotinib.
Your results may be different from what was seen in studies.
How Can I Get Ensacove?
Ensacove requires a prescription from a health care provider. You may also be able to get this medicine by joining a clinical trial. Talk to your health care provider or visit this website to learn more about participating in a study.
