Initial US Approval:
2024
Key Clinical Studies:
eXALT3 (NCT02767804)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
Dosage Administration:
- Select patients with ALK-positive locally advanced or metastatic NSCLC for treatment with ENSACOVE.
- Prior to initiating ENSACOVE, evaluate liver function tests and fasting blood glucose.
- Recommended dosage: 225 mg orally once daily with or without food until disease progression or unacceptable toxicity.
Dosage Forms and Strengths:
Capsules: 25 mg and 100 mg
Contraindications:
Hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.
Warnings and Precautions:
- Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis. Permanently discontinue in patients with ILD/pneumonitis.
- Hepatotoxicity: Monitor liver function tests during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Dermatologic Adverse Reaction: Monitor for dermatologic adverse reactions during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Bradycardia: Monitor heart rate regularly during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Hyperglycemia: Monitor serum glucose periodically during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Visual Disturbances: Advise patients to report visual symptoms during treatment with ENSACOVE. Withhold ENSACOVE and obtain ophthalmologic evaluation, then reduce the dose or permanently discontinue ENSACOVE.
- Increased Creatine Phosphokinase (CPK): Monitor CPK periodically during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Hyperuricemia: Monitor uric acid periodically during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions:
- Most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.
- Most common Grade 3-4 laboratory abnormality (incidence ≥2%) were increased uric acid, decreased lymphocytes, increased alanine aminotransferase, decreased phosphate, increased gamma glutamyl transferase, increased magnesium, increased amylase, decreased sodium, increased glucose, decreased hemoglobin, increased bilirubin, decreased potassium, and increased creatine phosphokinase.
Drug Interactions:
- Moderate or Strong CYP3A Inhibitors: Avoid concomitant use with ENSACOVE.
- Moderate or Strong CYP3A Inducers: Avoid concomitant use with ENSACOVE.
- P-gp Inhibitor: Avoid concomitant use with ENSACOVE. (7.1)
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
- Severe Hepatic Impairment: Avoid use of ENSACOVE in patients with severe hepatic impairment
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
