Lumakras
An oral targeted therapy for patients with advanced non-small cell lung cancer harboring a specific KRAS mutation.
Where Sotorasib is approved
All regulators →Of the three regulators tracked here, the first to approve Sotorasib was the US, on 28 May 2021. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Sotorasib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Sotorasib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 15 Sep 2040 (US 11426404).
- Latest patent on the drug substance itself: 20 May 2040 (US 11236091).
- Exclusivity ODE-507: Orphan drug exclusivity: treatment of adult patients with kras g12c-mutated metastatic colorectal cancer (mcrc), as determined by an FDA-ap…, until 16 Jan 2032.
- Exclusivity ODE-352: Orphan drug exclusivity: treatment of adult patients with kras g12c-mutated locally advanced or metastatic non-small cell lung cancer (NSCL…, until 28 May 2028.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 28 May 2028.
- Exclusivity I-962: New indication: in combination with panitumumab, for the treatment of adult patients with kras g12c-mutated metastatic colorectal cancer as…, until 16 Jan 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Sotorasib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Sotorasib works
All drug targets →- GTPase KRas inhibitor InhibitorTarget: KRAS KRas proto-oncogene, GTPase✓ In ChEMBL and the Guide to Pharmacology
- Colorectal cancerPhase 3
- Lung cancerPhase 3
- Biliary tract cancerPhase 2
- Breast cancerPhase 2
- CancerPhase 2
- Colorectal adenocarcinomaPhase 2
- Endometrial cancerPhase 2
- Malignant pancreatic neoplasmPhase 2
- Non-small cell squamous lung carcinomaPhase 2
- Ovarian cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4535757, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 10678, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Sotorasib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Sotorasib. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Sotorasib for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer NICE TA781 | Recommended (Cancer Drugs Fund) | 30 Mar 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Sotorasib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LumykrasEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
What Lumakras is used for
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. ( 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). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-…
How it works
12.1 Mechanism of Action Sotorasib is an inhibitor of KRAS G12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS. Sotorasib blocked KRAS signaling, inhibited cell growth, and promoted apoptosis only in KRAS G12C tumor cell lines. Sotorasib inhibited KRAS G12C in vitro and in vivo with minimal detectable off-target activity. In mouse tumor xenograft models, sotorasib-treatment led to tumor regressions and prolonged survival, and was associated with anti-tumor immunity in KRAS G12C …
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.