Drug · Small Molecule

Sotorasib

CI-DRUG-00000558Explore in graph →NCIt C154287 CHEMBL4535757 CIViC Approved

Regulatory

Approvals (7)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2025-01-16 (see label)	approved	Jan 16, 2025	openfda
US FDA	Lung Non-Small Cell Carcinoma	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.	approved	May 28, 2021	openfda
US FDA	—	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).accelerated	approved	May 28, 2021	openfda
US FDA	Malignant Colorectal Neoplasm

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated yesterdaySource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	21	13	5	42	7	CA, EU, US	May 28, 2021	Aug 27, 2018
Malignant Lung Neoplasm	Approved	Phase 3	10	5	2	22	2	EU, US	May 28, 2021	Mar 23, 2021
Malignant Breast Neoplasm	Phase2	Phase 2	1	1	0	1	0	—	—	Apr 7, 2023
Malignant Mesothelioma	Phase2	Phase 2	1	1	0	1	0

Curated evidence

Clinical evidence (19)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–19 of 19 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KRAS G12C19
Pan-RAF/MEK Molecular Glue NST-628

Clinical trials

Trials with this intervention (45)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–45 of 45 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05564377	Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial	recruiting	Phase 2	2,900	National Cancer Institute (NCI)NIH	2	Sep 29, 2026	clinicaltrials
NCT05920356	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)

Molecule

Record

Kind: Small Molecule
Mechanism: GTPase KRas inhibitor
Targets: 1 gene
UNII: 2B2VM6UC8G
Aliases: AMG 510, AMG-510, AMG510, CT-AMG510AMG-510AMG510, KRAS G12C INHIBITOR 9, KRAS MUTANT-TARGETING AMG 510, Lumakras, Lumykras, (R)-38, (S)-AMG-510, Sotorasib, SOTORASIB (AMG510) RACEMATE

Data updated 3 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX73	SOTORASIB
DIN (Health Canada)	02520095	LUMAKRAS
DIN (Health Canada)