Prescription medicine
Sotorasib Brand names: Lumakras
Sotorasib (Lumakras) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sotorasib FDA label on DailyMed (effective January 22, 2025); the NDA 214665 record on Drugs@FDA; every sotorasib label on DailyMed.
Highlights of the record
FDA label of January 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLUMAKRAS 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.
Forms and strengths
- 120 mg
- 240 mg
- 320 mg
Coated tablet.
On the market
- Earliest approval on file
- May 28, 2021 Lumakras, Amgen Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 15, 2040 Lumakras tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,319 through July 30, 2026
What is sotorasib used for?
From the label: indications and usageLUMAKRAS 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. ( 1.1 ) 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). […]
Conditions named in the indications of sotorasib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (LUMAKRAS), Amgen Inc, effective January 22, 2025 (SPL set c80a362c-7ac3-4894-a076-0691e68ef8c1), via openFDA; the full label on DailyMed
Is there a generic for sotorasib (Lumakras)?
No generic sotorasib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Lumakras tablets: the compound patent runs to May 20, 2040, and the last listed entry to September 15, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sotorasib label say about other medicines?
The sotorasib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name sotorasib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Panitumumab | warnings and precautions | In the pooled safety population of patients with CRC who received LUMAKRAS 960 mg in combination with panitumumab [see Adverse Reactions (6.1) ], hepatotoxicity occurred in 15% of patients, of which 4.8% were Grade 3. |
Source: FDA drug label (LUMAKRAS), Amgen Inc, effective January 22, 2025 (SPL set c80a362c-7ac3-4894-a076-0691e68ef8c1), via openFDA; the full label on DailyMed
What do FAERS reports show for sotorasib?
The FDA Adverse Event Reporting System holds 3,319 reports that list sotorasib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 788 are coded as a death and 670 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,226, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sotorasib?
27 other medicines are given the same way (oral) and in the same FDA class as sotorasib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Dacomitinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sotorasib
- 27 medicines for the same use
- Sotorasib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other