LUMAKRAS
LUMAKRAS (sotorasib) is a RAS GTPase family inhibitor indicated for the treatment of adult patients with KRAS G12C-mutated malignancies. It is used as a single agent for locally advanced or metastatic non-small cell lung cancer in patients who have received at least one prior systemic therapy. The drug is also indicated in combination with panitumumab for metastatic colorectal cancer following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Patient eligibility for both indications must be determined by an FDA-approved test for the KRAS G12C mutation.
How LUMAKRAS Works
Sotorasib is an inhibitor of KRAS G12C, a mutant-oncogenic form of the KRAS protein. The drug forms an irreversible covalent bond with the protein, locking it in an inactive state and preventing the downstream signaling that drives tumor cell growth. This mechanism specifically targets the mutant protein without affecting wild-type KRAS. In colorectal cancer, sotorasib is used with an EGFR antagonist to overcome resistance mechanisms associated with epidermal growth factor receptor activation.
Details
- Status
- Prescription
- First Approved
- 2021-05-28
- Routes
- ORAL
- Dosage Forms
- TABLET
LUMAKRAS Approval History
What LUMAKRAS Treats
2 indicationsLUMAKRAS is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
- KRAS G12C-mutated metastatic colorectal cancer
LUMAKRAS Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
LUMAKRAS Competitors
Pro10 other drugs also target EGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (EGFR). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUMAKRAS FDA Label Details
ProIndications & Usage
FDA Label (PDF)LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic 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 c...
LUMAKRAS Patents & Exclusivity
Patents (90 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.