LUMAKRAS

4 Geriatrics 01 / 2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 8

1 Adverse Reaction Overview The data described in the 7 WARNINGS AND PRECAUTIONS section reflect the safety of LUMAKRAS 960 mg orally once daily in 748 patients with any tumour type across multiple clinical studies. 3% were exposed for greater than one year.

2 months (range: 0 to 47 months). 5%). Non-Small Cell Lung Cancer The data described below reflect the safety of LUMAKRAS in 554 patients with KRAS G12C- mutated locally advanced or metastatic NSCLC who received 960 mg orally once daily as monotherapy.

This information excludes any event with disease progression-related preferred terms. 4% exposed for at least 1 year. The median age of patients was 65 years old (range: 32 to 88 years); 47% female; 64% Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1; 80% White, 16% Asian and 2% Black.

5% of NSCLC patients treated with LUMAKRAS. 5%) and diarrhea (2%). 6% of the population. 2%). 1% of patients. 7%). 0% of patients with NSCLC treated at 960 mg QD. 0%). The most common adverse reactions (≥ 20% of patients) reported in the pooled safety population were diarrhea, musculoskeletal pain, fatigue, nausea and hepatotoxicity.

Increased incidence of hepatotoxicity and pneumonitis have been reported in patients who received immunotherapy ≤ 3 months prior to starting LUMAKRAS. NOC/c LUMAKRAS® (sotorasib) Page 12 of 31 Table 4 summarizes the common adverse reactions (≥ 10%) identified across clinical trials in patients receiving LUMAKRAS monotherapy at 960 mg daily.

Adverse Drug Reactions are organized by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 4. Within each SOC, preferred terms are arranged by decreasing frequency. Table 4. 0 a Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower.

b Fatigue includes fatigue and asthenia. c Edema includes edema peripheral, edema, edema generalized, localized edema. d Hepatotoxicity includes alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, drug-induced liver injury, hepatitis, hepatotoxicity, liver function test increased, transaminases increased, transaminases abnormal, hypertransaminasaemia, hyperbilirubinaemia.

4 Geriatrics 01 / 2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 24 16 NON-CLINICAL TOXICOLOGY […]

LUMAKRAS is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.