NDAORALTABLETPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
30
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUMAKRAS (sotorasib) is an oral small-molecule KRAS G12C inhibitor approved by the FDA in May 2021 for treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC). It directly binds to and inhibits the oncogenic KRAS G12C mutation, a previously undruggable target. The drug represents a precision oncology breakthrough for a specific patient population with this genetic alteration.
$140MPart D
Peak14.0 years to LOEThe product is in peak commercial phase with $140M in Medicare Part D spending (2023) and approximately 7,447 claims, indicating solid market penetration and an established brand team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (30)
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Started Jan 2026
14 enrolled
Advanced Solid Tumors
Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
Started Aug 2025
102 enrolled
Non-Small Cell Lung Cancer
AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC
Started Mar 2025
0Metastatic Non Small Cell Lung CancerKRAS G12C
A Study of Sotorasib in People With Brain Tumors
Started Jan 2025
16 enrolled
Brain Tumor
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation
Started Nov 2024
104 enrolled
Advanced Solid Tumors Harboring KRAS G12C Mutation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.