INDICATION

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).

NSCLC

In KRAS G12C–mutated locally advanced or metastatic NSCLC following first line of therapy:

It’s time to move forward with LUMAKRAS® (sotorasib)

Discover the data behind LUMAKRAS®

Confirmed once-daily oral dosing¹,²*

Established safety¹

Comprehensive support³

Amgen ^® SupportPlus

CodeBreaK 100 was a single-arm, open-label, global, multicenter clinical trial with the Phase 2 portion evaluating LUMAKRAS® in 126 patients with locally advanced or metastatic KRAS G12C–mutated NSCLC who progressed on prior therapy. Major efficacy outcomes in patients with ≥ 1 measurable lesion (BICR according to RECIST v1.1; n=124) were objective response rate (36% [95% CI: 28–45]; CR: 2%, PR: 35%), and duration of response (median: 10.0 months [range 1.3+, 11.1]; ≥ 6 months: 58% of patients observed beyond landmark time).1,4

NSCLC: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) list sotorasib as a subsequent therapy option for patients with KRAS G12C–positive advanced NSCLC (NCCN Category 2A recommendation)^5,†,‡

CNS: NCCN Guidelines^® list sotorasib as a subsequent therapy option for patients with KRAS G12C–positive NSCLC with CNS involvement (NCCN Category 2B recommendation)⁶

+Symbol indicates censoring.

*Treat until disease progression or unacceptable toxicity.¹

^†NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.⁵

^‡Does not include locally advanced.⁵

BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; KRAS, Kirsten rat sarcoma viral oncogene homolog; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

IMPORTANT SAFETY INFORMATION

Hepatotoxicity

LUMAKRAS^® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
In the pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
In this pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg, 17% of patients who received LUMAKRAS^® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS^®. LUMAKRAS^® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
In this pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS^® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS^® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS^®, with or without corticosteroid treatment.
Monitor liver function tests (ALT, AST, alkaline phosphatase, and total bilirubin) prior to the start of LUMAKRAS^®, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS^® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.

Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS^® can cause ILD/pneumonitis that can be fatal.
In the pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS^® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS^®-treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS^® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS^® if no other potential causes of ILD/pneumonitis are identified.

Most Common Adverse Reactions

The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.

Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over‑the‑counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS^®.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS^® 4 hours before or 10 hours after a locally acting antacid.

INDICATION

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 LUMAKRAS^® Prescribing Information.

References: 1. LUMAKRAS® (sotorasib) prescribing information, Amgen. 2. Hochmair MJ, et al. Eur J Cancer. 2024;208:114204. 3. Data on file, Amgen; [Amgen SupportPlus Patients and HCPs]. 4. Sotorasib CSR. Amgen; 2021. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.7.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 8, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers v.1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed September 3, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.