Sotorasib
Also known as Lumakras
AMGEN INC AMGN · Colorectal Cancer (CRC); Metastatic Colorectal Cancer; Non-Small Cell Lung Cancer (NSCLC)
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
Approved
NDA214665,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AMGEN INC AMGN Source: Company record for AMGEN INC (opens in a new tab)
- Indications
- Colorectal Cancer (CRC); Metastatic Colorectal Cancer; Non-Small Cell Lung Cancer (NSCLC) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 214665 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 214665 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 19 Apr 20223 linked trials
- Filed Completed
- Approved Current stageFirst approval 28 May 2021
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Sotorasib. Editors add each one with its source.
Filed application
No filed application is on record for Sotorasib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Sotorasib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06252649ClinicalTrials.gov record for NCT06252649 (opens in a new tab)CodeBreaK 301 | Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation | Phase 3 | Recruiting | 450 (estimated) | 25 Sep 2028 (estimated) | No |
Publications listing CodeBreaK 301 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05920356ClinicalTrials.gov record for NCT05920356 (opens in a new tab) | A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) | Phase 3 | Recruiting | 750 (estimated) | 30 Jun 2027 (estimated) | No |
| NCT05198934ClinicalTrials.gov record for NCT05198934 (opens in a new tab)CodeBreak300 | Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation | Phase 3 | Completed | 160 (actual) | 16 Jul 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05198934 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CodeBreak300 Serious adverse events (All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.): Trifluridine and Tipiracil or Regorafenib 15 of 51; Sotorasib 240 mg + Panitumumab 17 of 53; Sotorasib 960 mg + Panitumumab 14 of 53 Source: ClinicalTrials.gov results for NCT05198934 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing CodeBreak300 (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA214665Action letter for NDA214665 (opens in a new tab) | Supplement 9 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA214665Action letter for NDA214665 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedConditional
Lumykras (EMEA/H/C/005522)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- Amgen Europe B.V.
- Active substance (INN)
- sotorasib
- ATC code
- L01XX73
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Lumykras (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 214665 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06252649 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05920356 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05198934 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA214665 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.