Jideytro

Jideytro is used to treat non-small cell lung cancer (NSCLC) in adults that has spread within the chest or other parts of the body and is caused by an abnormal ROS1 gene and who have received a ROS1 kinase inhibitor. Jideytro (zidesamtinib) is taken once daily.

• It is not known if Jideytro is safe and effective in children.

Jideytro (zidesamtinib) is a kinase inhibitor that works by blocking ROS1, an abnormal protein that drives some lung cancers to grow, including forms that have become resistant to earlier ROS1 treatments. It also acts on related proteins (ALK and TRK). In laboratory and animal studies, zidesamtinib stopped cancer cells with ROS1 changes from growing and slowed tumor growth, including tumors in the brain. Jideytro is a targeted cancer treatment, not chemotherapy.

Jideytro received FDA approval on July 22, 2026, under the Breakthrough and Orphan Drug designation. Jideytro is highly selective for ROS1 and offers broad resistance-mutation coverage and brain penetration.

Jideytro's approval was based on the global single-arm phase I/II ARROS-1 trial (NCT05118789; 117 patients), which reported an objective response rate of 44% (95% CI: 34-53%), with responses lasting at six and 12 months in 82% and 69% of patients, respectively.

Take Jideytro exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Jideytro unless your healthcare provider tells you to. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Jideytro if you develop side effects.

• Take Jideytro once a day at about the same time each day with or without food.
• Swallow Jideytro tablets whole. Do not split, chew, crush, or dissolve the tablets. Do not take a tablet if it is broken, cracked, or damaged.
• If you miss a dose of Jideytro, take it as soon as possible. If it has been 12 or more hours since you took your last dose, just skip the dose and take it at your next regularly scheduled time.
• If you vomit at any time after taking Jideytro, do not take another dose. Wait to take your next dose at your regularly scheduled time.

Before taking Jideytro, tell your healthcare provider about all your medical conditions, including if you:

• have nervous system (neurological) or psychiatric problems.
• have heart problems, including a condition called long QT syndrome.
• have lung or breathing problems other than lung cancer.
• are pregnant or plan to become pregnant. Jideytro can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Jideytro. Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with Jideytro. Use effective birth control (contraception) during treatment and for 6 months after the last dose of Jideytro. Talk to your healthcare provider about birth control methods that may be right for you. Males with female partners who can become pregnant: Use effective birth control during treatment and for 3 months after the last dose of Jideytro.
• are breastfeeding or plan to breastfeed. It is not known if Jideytro passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of Jideytro. Talk to your healthcare provider about the best way to feed your baby during treatment with Jideytro.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious side effects and warnings

Jideytro can cause serious side effects, including:

• Central nervous system (CNS) effects. Tell your healthcare provider right away if you, or your family member taking Jideytro, develop any new or worsening CNS symptoms during treatment, including: dizziness fainting walking, balance, or coordination problems forgetfulness, confusion, attention or thinking problems speaking problems seizures mood or personality changes including anxiety, irritability depression, including thoughts of suicide or dying seeing or hearing things that are not real (hallucinations).
• Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening or cause sudden death. Your healthcare provider will do tests before and during your treatment with Jideytro to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment with Jideytro.
• Lung problems. Jideytro can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you get any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough (with or without mucus), or fever.
• Bone fractures. Jideytro can increase your risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you develop pain, changes in movement, or bone abnormalities.
• Muscle pain, tenderness, and weakness (myalgia). Jideytro can cause myalgia with an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your CPK blood levels every 2 weeks during the first month, then every 1 to 2 months and as needed if you get unexplained muscle pain, tenderness, or weakness during your treatment with Jideytro. Tell your healthcare provider if you develop any of these symptoms.
• Inflammation of the pancreas (pancreatitis). Jideytro may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with Jideytro. Tell your healthcare provider right away if you get any signs and symptoms of pancreatitis, including upper stomach (abdominal) pain that may spread to the back and get worse with eating, weight loss, or nausea.

Common side effects

The most common side effects of Jideytro are:

• swelling (edema)
• numbness or tingling in your arms or legs
• constipation
• tiredness
• shortness of breath.

The most common severe abnormal blood test results are increased creatine phosphokinase (CPK), increased triglycerides, decreased white blood cell counts, and decreased red blood cell counts.

Jideytro may cause fertility problems in males and females. Talk to your healthcare provider if fertility is a concern for you.

These are not all the possible side effects of Jideytro. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual dose of Jideytro for ROS1-positive NSCLC

• 100 mg once a day.
• Continue until disease progression or unacceptable toxicity.

Do not drive or operate heavy machinery during treatment if you develop side effects that can impact your mental alertness or coordination. See "Central nervous system (CNS) effects" in the "What are the possible side effects of Jideytro?" section above.

Taking Jideytro with certain other medicines may affect the amount of Jideytro or other medicines in your blood and may cause side effects or affect the way that Jideytro or other medicines work.

Your body uses an enzyme called CYP3A to break down Jideytro. Some other medicines and foods change how fast this enzyme works, which can make Jideytro less effective or raise the risk of side effects. Because of this, avoid taking Jideytro with:

• Medicines or foods that slow CYP3A down (strong or moderate "inhibitors"). These raise the amount of Jideytro in your blood and can increase side effects. Examples include some antifungal medicines (such as itraconazole or ketoconazole), certain antibiotics (such as clarithromycin), and grapefruit or grapefruit juice.
• Medicines that speed CYP3A up (strong or moderate "inducers"). These lower the amount of Jideytro in your blood and can make it work less well. Examples include some seizure medicines (such as carbamazepine or phenytoin), the antibiotic rifampin, and the herbal supplement St John's wort.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Store Jideytro at room temperature between 68°F and 77°F (20°C and 25°C).

Keep Jideytro and all medicines out of the reach of children.

Active ingredient: zidesamtinib

Inactive ingredients: The tablet core contains hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, titanium dioxide, triacetin, and yellow iron oxide. The 25 mg tablet film coating also contains red iron oxide.

Jideytro (zidesamtinib) is distributed by Nuvalent, Inc., Cambridge, MA 02142 USA and is a trademark of Nuvalent, Inc.