JIDEYTRO

JIDEYTRO is an FDA-registered drug product whose active ingredient is ZIDESAMTINIB. It is labelled by Nuvalent, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 85001-101, application NDA220185, label effective 20260722. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ZIDESAMTINIB are most often described in connection with: kinase inhibitor, treatment adult, locally advanced, metastatic ros, positive non-small, cell lung, cancer nsclc, received prior. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )

2 DOSAGE AND ADMINISTRATION Recommended Dosage : 100 mg orally once daily with or without food until disease progression or unacceptable toxicity. ( 2.2 ) 2.1 Recommended Testing and Evaluation Before Initiating JIDEYTRO Before initiating JIDEYTRO, evaluate creatine phosphokinase (CPK) level, electrocardiogram (ECG), electrolytes, lipase and amylase [see Warnings and Precautions ( 5.2 , 5.5 , 5.6 )] . 2.2 Recommended Dosage The recommended dosage of JIDEYTRO is 100 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity [see Clinical Pharmacology ( 12.3 )] . Swallow JIDEYTRO tablets whole. Do not split, chew, crush, or dissolve the tablet prior to swallowing. Missed Dose If a dose of JIDEYTRO is missed within 12 hours of the regularly scheduled dose, administer the missed dose as soon as possible. If a dose is missed by 12 hours or more, take the next dose at its scheduled time. Vomiting If vomiting occurs at any time after taking JIDEYTRO, take the next dose at its scheduled time. 2.3 Dosage Modifications of JIDEYTRO for Adverse Reactions The recommended dosage reductions of JIDEYTRO for the management of adverse reactions are provided in Table 1 . Table 1: Recommended Dose Reductions for JIDEYTRO Adverse Reactions Dose Reduction Recommended Dose and Schedule First 75 mg once daily Second 50 mg once daily Permanently discontinue JIDEYTRO in patients unable to tolerate 50 mg once daily. After dose reduction of JIDEYTRO for adverse reactions, do not re-escalate the dose. The recommended dosage modifications of JIDEYTRO for the management of adverse reactions are provided in Table 2 . Table 2: Recommended Dosage Modifications for JIDEYTRO Adverse Reactions *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Adverse Reaction Severity* Dosage Modification Central Nervous System Adverse Reactions [see Warnings and Precautions (5.1)] Intolerable Grade 2 Withhold JIDEYTRO until Grade ≤ 1 or baseline. Resume JIDEYTRO at same or reduced dose, as clinically appropriate. Grade 3 Withhold JIDEYTRO until Grade ≤ 1 or baseline. Resume JIDEYTRO at reduced dose. Grade 4 Permanently discontinue JIDEYTRO. QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] Grade 2 (QTc interval 481-500 msec) Withhold JIDEYTRO until recovery to Grade ≤ 1 or baseline. Correct electrolytes and/or change concomitant medications. Resume JIDEYTRO at same dose. Grade 3 (QTc interval ≥501 msec or QTc interval increase of >60 msec from baseline) Withhold JIDEYTRO until recovery to Grade ≤ 1 or baseline. Correct electrolytes and/or change concomitant medications. Resume JIDEYTRO at a reduced dose. Grade 4 (Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrhythmia) Permanently discontinue JIDEYTRO. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.3)] Grade 1 Withhold JIDEYTRO if ILD/pneumonitis occurs or is suspected until recovery to Grade 0. If resolved within 6 weeks, resume JIDEYTRO at the same dose. If unresolved after 6 weeks, permanently discontinue JIDEYTRO. Recurrence: Permanently discontinue JIDEYTRO. Grade 2 Withhold JIDEYTRO if ILD/pneumonitis occurs or is suspected until recovery to Grade 0 or baseline. If resolved within 6 weeks, resume JIDEYTRO at a reduced dose. If unresolved after 6 weeks, permanently discontinue JIDEYTRO. Recurrence: Permanently discontinue JIDEYTRO. Grade 3 or 4 Permanently discontinue JIDEYTRO. Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.5)] CPK elevation > 5 times ULN Withhold JIDEYTRO until recovery to baseline or ≤ 2.5 times ULN, then resume JIDEYTRO at same dose. CPK elevation > 10 times ULN or Recurrence of CPK elevation of >5 times ULN Withhold until recovery to baseline or ≤2.5 times ULN, then resume JIDEYTRO at a reduced dose. Increased lipase or amylase [see Warnings and Precautions (5.6)] Grade 3 Withhold JIDEYTRO until Grade ≤ 2 or baseline. If recovered to baseline or Grade ≤ 2 within 14 days, resume JIDEYTRO at a reduced dose; otherwise permanently discontinue JIDEYTRO. Grade 4 Permanently discontinue JIDEYTRO. Pancreatitis [see Warnings and Precautions (5.6)] Grade 3 or Grade 4 Permanently discontinue JIDEYTRO. Other Adverse Reactions [see Adverse Reactions (6.1)] Intolerable Grade 2 or Grade 3 or Grade 4 Withhold JIDEYTRO until Grade ≤ 1 or baseline. If resolution occurs within 4 weeks, resume JIDEYTRO at the same dose for intolerable Grade 2 or Grade 3 adverse reactions. If resolution occurs within 4 weeks, resume JIDEYTRO at the next lower dose for Grade 4 adverse reactions. Permanently discontinue JIDEYTRO if adverse reaction does not resolve within 4 weeks. Permanently discontinue JIDEYTRO for recurrent Grade 4 events.

4 CONTRAINDICATIONS None. None.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System Adverse Reactions [see Warnings and Precautions ( 5.1 )] QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions ( 5.3 )] Skeletal Fractures [see Warnings and Precautions ( 5.4 )] Myalgia with Creatine Phosphokinase Elevation [see Warnings and Precautions ( 5.5 )] Pancreatic Toxicity [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥15%) were: edema, peripheral neuropathy, constipation, fatigue, and dyspnea. ( 6.1 ) Most common Grade 3 or 4 laboratory abnormalities (≥2%) were: increased CPK, increased triglycerides, decreased lymphocytes and decreased hemoglobin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Nuvalent, Inc. at toll-free phone 1-844-NUVL-111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to JIDEYTRO in 446 patients with ROS1-positive NSCLC (n=432) and other solid tumors (n=14) who received JIDEYTRO at a dose of 100 mg orally once daily until disease progression or unacceptable toxicity in ARROS-1 [see Clinical Studies ( 14.1 )] . Among 446 patients who received JIDEYTRO, 44% were exposed for 6 months or longer and 14% were exposed for greater than one year. In this pooled safety population, the most common (≥15%) adverse reactions included: edema (38%), peripheral neuropathy (25%), constipation (17%), fatigue (16%), dyspnea (15%). The most common Grade 3 or 4 laboratory abnormalities (≥2%), were increased lipase (8%), increased creatine phosphokinase (CPK) (4%), increased triglycerides (3.5%), decreased lymphocytes (2.7%), and decreased hemoglobin (2.3%). Previously Treated ROS1-positive NSCLC The safety of JIDEYTRO was evaluated in ARROS-1 [see Clinical Studies ( 14.1 )] . Patients received JIDEYTRO 100 mg orally once daily until disease progression or unacceptable toxicity. Among the 432 patients who received JIDEYTRO, 44% were exposed to JIDEYTRO for 6 months or longer, and 15% were exposed for greater than 1 year. The median age of patients who received JIDEYTRO was 58 years (range: 26 to 87); 62% female; 41% White, 41% Asian, 3.7% Black or African American, 0.2% American Indian or Alaska Native, 14% other races, multiple races or race unknown, and 4.6% of patients were of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 22% of patients who received JIDEYTRO. Serious adverse reactions in ≥2% of patients included pneumonia (6%) and dyspnea (2.5%). Fatal adverse reactions occurred in 2.3% of patients who received JIDEYTRO, including pneumonia (0.5%), cerebrovascular accident (0.2%), COVID-19 (0.2%), dyspnea (0.2%), infectious pleural effusion (0.2%), influenza (0.2%), myocardial infarction (0.2%), myocarditis (0.2%), and respiratory failure (0.2%). Permanent discontinuation of JIDEYTRO due to an adverse reaction occurred in 2.3% of patients. Adverse reactions resulting in permanent discontinuation of JIDEYTRO occurring in ≥2 patients were pneumonia (0.7%) and pneumonitis (0.5%). Dosage interruptions of JIDEYTRO due to an adverse reaction occurred in 30% of patients. Adverse reactions which required dosage interruption in ≥1% of patients included pneumonia (4.6%), increased creatine phosphokinase level (3.0%), peripheral neuropathy (1.9%), peripheral edema (1.6%), COVID-19 (1.4%), and dyspnea and elevated alanine aminotransferase level (each in 1.2%). Dose reductions of JIDEYTRO due to an adverse reaction occurred in 10% of patients. Adverse reactions which required dosage reduction in ≥1% of patients included peripheral edema (1.9%) and peripheral neuropathy (1.2%). Table 3 summarizes the adverse reactions that occurred in the ARROS-1 trial. Table 3: Adverse Reactions (≥10%) in Patients with ROS1-Positive NSCLC Who Received JIDEYTRO in ARROS-1 1 Based on NCI CTCAE v5.0 *Grouped term Adverse Reaction 1 JIDEYTRO N=432 All Grades (%) Grade 3 or 4 (%) General Disorders Edema* 36 0.7 Fatigue* 16 0.7 Nervous System Disorders Peripheral neuropathy * 25 0.9 Dysgeusia * 15 0 Dizziness * 12 0.2 Headache 12 0.2 Gastrointestinal disorders Constipation 17 0 Diarrhea* 11 0.5 Respiratory, thoracic, and mediastinal disorders Dyspnea* 15 3 Cough* 13 0 Musculoskeletal and connective tissue disorders Myalgia* 13 0 Arthralgia 11 0.7 Skin and subcutaneous tissue disorders Rash* 12 0.5 Eye disorders Vision disorders* 12 0 Infections Pneumonia* 11 6 Clinically relevant adverse reactions in <10% of patients receiving JIDEYTRO were cognitive disorders, psychiatric disorders, stomatitis, ataxia, ILD/pneumonitis, QTc prolongation, pancreatitis, and ankle fracture. Table 4 summarizes the laboratory abnormalities in ARROS-1. Table 4: Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with ROS1-Positive NSCLC Who Received JIDEYTRO in ARROS-1 1 Based on NCI CTCAE v5.0 2 The denominator used to calculate the rate varied from 37 to 429 based on the number of patients with a baseline value and at least one post-baseline treatment value. Laboratory Abnormality 1 JIDEYTRO 2 All Grades (%) Grade 3 or 4 (%) Lipid Profile Cholesterol increased 47 1.5 Triglycerides increased 47 3.7 Chemistry Creatine phosphokinase increased 37 4 Aspartate aminotransferase increased 30 0.9 Lipase increased 26 8 Alanine aminotransferase increased 23 1.2 Amylase increased 23 0 Alkaline phosphatase increased 21 0 Hematology Hemoglobin decreased 30 2.1 Eosinophils increased 27 0

What is JIDEYTRO used for?
1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 …

Who makes JIDEYTRO?
Nuvalent, Inc. is the labeler of record for JIDEYTRO.

What form does JIDEYTRO come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is JIDEYTRO prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has JIDEYTRO been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.