|All Grades (%)||Grades 3 to 4 (%)|
|Respiratory, thoracic, and mediastinal disorders|
|Musculoskeletal and connective tissue disorders|
|General disorders and administration site conditions|
|Metabolism and nutrition disorders|
|Infections and infestations|
|Skin and subcutaneous tissue disorders|
Permanent discontinuation of LUMAKRAS™ due to an adverse reaction occurred in 9% of patients. Adverse reactions resulting in permanent discontinuation of LUMAKRAS™ in ≥ 2% of patients included hepatotoxicity (4.9%)
*Grading defined by NCI CTCAE version 5.0.
†Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower.
‡Hepatotoxicity includes alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, drug-induced liver injury, hepatitis, hepatotoxicity, liver function test increased, transaminases increased.
§Cough includes cough, productive cough, and upper-airway cough syndrome.
**Dyspnea includes dyspnea and dyspnea exertional.
††Musculoskeletal pain includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, and pain in extremity.
‡‡Fatigue includes fatigue and asthenia.
§§Edema includes generalized edema, localized edema, edema, edema peripheral, periorbital edema, and testicular edema.
***Pneumonia includes pneumonia, pneumonia aspiration, pneumonia bacterial, and pneumonia staphylococcal.
†††Rash includes dermatitis, dermatitis acneiform, rash, rash-maculopapular, rash pustular.
KRAS, Kirsten rat sarcoma viral oncogene homolog; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NSCLC, non-small cell lung cancer.
|Grades 1 to 4 (%)||Grades 3 to 4 (%)|
|Increased aspartate aminotransferase||39||9|
|Increased alanine aminotransferase||38||11|
|Increased alkaline phosphatase||33||2.5|
|Increased urine protein||29||3.9|
|Increased activated partial thromboplastin time||23||1.5|
‡‡‡N=number of patients who had at least one on-study assessment for the parameter of interest.
Interstitial Lung Disease (ILD)/Pneumonitis
Most common adverse reactions
LUMAKRAS™ is indicated for the treatment of adult patients with KRAS G12C‑mutated locally advanced or metastatic non‑small cell lung cancer (NSCLC), as determined by an FDA‑approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Please see full Prescribing Information.