Initial US Approval:
2024
Key Clinical Studies:
MARIPOSA (NCT04487080)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
Indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Dosage Administration:
The recommended dosage of LAZCLUZE is 240 mg orally once daily with or without food, given in combination with amivantamab.
- Continue treatment until disease progression or unacceptable toxicity.
- Administer LAZCLUZE any time prior to amivantamab when given on the same day.
- Refer to the amivantamab prescribing information for recommended amivantamab dosing information.
- Administer anticoagulant prophylaxis to prevent venous thromboembolic events (VTE) for the first four months of treatment.
Dosage Forms and Strengths:
Tablets: 80 mg and 240 mg.
Contraindications:
None.
Warnings and Precautions:
Venous Thromboembolic Events (VTE): Prophylactic anticoagulation is recommended for the first four months of treatment. Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold LAZCLUZE and amivantamab based on severity. Once anticoagulant treatment has been initiated, resume LAZCLUZE and amivantamab at the same dose at the discretion of the healthcare provider. Permanently discontinue amivantamab and continue LAZCLUZE for recurrent VTE despite therapeutic anticoagulation.
Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Withhold LAZCLUZE and amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.
Dermatologic Adverse Reactions: May cause severe rash including acneiform dermatitis. Administer alcohol-free emollient cream and encourage patients to limit sun exposure during and for 2 months after treatment to reduce the risk of dermatologic reactions. Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity.
Ocular Adverse Reactions: Promptly refer patients with new or worsening signs and symptoms of ocular adverse reactions, including keratitis, to an ophthalmologist for evaluation. Withhold, reduce the dose, or permanently discontinue amivantamab and continue LAZCLUZE based on severity.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions:
The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction (amivantamab), musculoskeletal pain, edema, stomatitis, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.
The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
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.
