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1 INDICATIONS AND USAGE

DRUG-A is indicated as monotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations in the first-line setting under the approved EU label.

Use outside EGFR-positive first-line metastatic NSCLC is not authorised. Adjuvant or post-resection use must not be presented as approved.

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2 POSOLOGY AND METHOD OF ADMINISTRATION

The recommended dose of DRUG-A is 80 mg once daily, orally, with or without food. Treatment continues until disease progression or unacceptable toxicity.

Dose reduction to 40 mg once daily is permitted only within approved EU label boundaries for documented toxicity. Missed doses must not be doubled.

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4 CONTRAINDICATIONS

DRUG-A is contraindicated in patients with hypersensitivity to the active substance or excipients.

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4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Monitor for interstitial lung disease (ILD): new dyspnoea, cough, or fever require urgent assessment. Grade 3 or higher ILD requires permanent discontinuation.

Baseline and periodic hepatic function and QT interval assessment is recommended. Use caution with QT-prolonging co-medications.

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4.8 UNDESIRABLE EFFECTS

Common adverse reactions include rash, diarrhoea, paronychia, stomatitis, and decreased appetite. Serious reactions include ILD and severe cutaneous adverse events.