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
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Discover LUMAKRAS NCCN Guidelines® recommended option Mechanism of action

Discover LUMAKRAS®
LUMAKRAS® (sotorasib) is the
1st
approved KRASG12C inhibitor
in NSCLC
LUMAKRAS®, a first-in-class KRASG12C inhibitor, was FDA-approved with accelerated approval in May 20211,2

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).1,3

2022winner

In 2022, LUMAKRAS® won the Prix Galien USA award for Pharmaceutical Agent4,*

world

LUMAKRAS® is supported by the longest clinical follow-up and the largest pooled safety analysis among KRASG12C inhibitors5,†

number1

LUMAKRAS® is the #1 prescribed KRASG12C inhibitor6,‡

The number of patients and practitioners whose lives have been touched by LUMAKRAS® continues to grow:

Infographic_mr Infographic_mr-mob

*Prix Galien USA is an independent distinction that awards pharmaceutical products introduced in the public market and achievements of research teams. To be eligible, products must have received marketing approval in the USA by December 31 of the year preceding the awards, but not more than 5 years earlier than December 31 of that year, unless the award is for a new and innovative indication, which must have been added within the previous 5 years.9,10

†Trials within the pooled safety analysis included CodeBreaK 100, 101, 200, and 105.5,11

‡Based on IQVIA LAAD data from January 1, 2023 to May 31, 2025 among patients with metastatic lung cancer and confirmed prior treatment.6

§From June 5, 2021 to June 27, 2025. Data include new-to-brand prescriptions from specialty pharmacies. There is a deidentified patient ID associated with each Rx that allows differentiation between new patients and refills.7

**From June 5, 2021 to June 27, 2025. Data sources include specialty pharmacy data, IQVIA XPO, IQVIA LAAD, Intrinsiq, IPM, and Ontada. Unique HCPs are first identified using individual data sources and then deduped to identify the total number of HCPs.8

BICR, blinded independent central review; CI, confidence interval; CR, complete response; HCP, healthcare professional; KRAS, Kirsten rat sarcoma viral oncogene homolog; NSCLC, non-small cell lung cancer; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

nccn guidelines remmonded
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)12,*,†
CNS: NCCN Guidelines® list sotorasib as a subsequent therapy option for patients with KRAS G12C–positive NSCLC with CNS involvement (NCCN Category 2B recommendation)13

*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.12

†Does not include locally advanced.12

CNS, central nervous system; KRAS, Kirsten rat sarcoma viral oncogene homolog; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer.

Mechanism of action

LUMAKRAS® is not a chemotherapy, immunotherapy, or TKI. It’s a highly selective* oral inhibitor designed specifically for patients with a KRAS G12C mutation1

KRASG12CGDP KRASG12CGDP_mobile
Discover the efficacy data behind LUMAKRAS®

*Cysteine proteome analysis of 6,451 peptides showed sotorasib only covalently engages with Cys12 of KRASG12C. Preclinical studies in 22 cell lines and xenograft models demonstrated that sotorasib does not inhibit KRAS wild type or non-KRAS G12C lines/tumors.14

GDP, guanosine diphosphate; KRAS, Kirsten rat sarcoma viral oncogene homolog; TKI, tyrosine kinase inhibitor.

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. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug. Accessed July 2, 2025. 3. Sotorasib CSR. Amgen; 2021. 4. The Galien Foundation. https://www.prnewswire.com/news-releases/the-galien-foundation-honors-2022-prix-galien-award-recipients-301662219.html. Accessed July 2, 2025. 5. Data on file, Amgen; [Trial Sites]. 6. Data on file, Amgen; [Most prescribed]. 7. Data on file, Amgen; [Unique patients]. 8. Data on file, Amgen; [Unique prescribers]. 9. The Galien Foundation. https://www.galienfoundation.org/what-you-must-know. Accessed July 2, 2025. 10. The Galien Foundation. https://candidates.prix-galien-usa.com/submissions/eligibility. Accessed July 2, 2025. 11. Skoulidis F, et al. Nat Rev Cancer. 2019;19:495–509. 12. 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 July 10, 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. 13. 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 June 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. 14. Canon J, et al. Nature. 2019;575(7781):217–223.