Drug · Small Molecule

Sorafenib

CI-DRUG-00000556Explore in graph →NCIt C61948 CHEMBL1336 CIViC Approved

Regulatory

Approvals (13)

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

openfdaRegulatory9 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2017-12-22 (see label)	approved	Dec 22, 2017	openfda
US FDA	—	Efficacy supplement 2013-11-22 (see label)	approved	Nov 22, 2013

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 14 hours agoSource 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	30	12	78	408	13	CA, EU, US	Dec 1, 2005	2002-07
Malignant Liver Neoplasm	Approved	Phase 4	12	3	49	165	1	US	Dec 1, 2005	2002-08
Malignant Thyroid Gland Neoplasm	Approved	Phase 2	2	1	0	8	1	US	Dec 1, 2005	2006-02
Malignant Kidney Neoplasm	Approved	Phase 3	1	1	11	42	1

Curated evidence

Clinical evidence (96)

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

civicCuratedShowing 51–96 of 96 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
FGFR2 Amplification1
Sorafenib	Gastric Adenocarcinoma

Clinical trials

Trials with this intervention (443)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 301–350 of 443 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
NCT00411671	BATTLE Program: Sorafenib in Patients With NSCLC	completed	Phase 2	105	M.D. Anderson Cancer CenterOTHER	1	Feb 11, 2016	clinicaltrials
NCT00533585	BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)	completed	Phase 1	23

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase RAF inhibitor; Platelet-derived growth factor receptor beta inhibitor; Stem cell growth factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor; Serine/threonine-protein kinase B-raf inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor
Targets: 9 genes
UNII: 5T62Q3B36J
Aliases: APO-SORAFENIB, BA4 43 9006, BAY 43 9006, BAY 43-9006, BAY 439006, BAY439006, NEXAVAR, Sorafenib, Sorafenib Accord, Sorafenib Tosylate, SORAFENIB TOSYLATE

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (7)

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

System	Code	Label
ATC (WHO)	L01EX02	SORAFENIB
DIN (Health Canada)	02284227

FGF3 Amplification2
Sorafenib	Hepatocellular Carcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID1966 FGF3/FGF4 amplification was observed in around 2% of HCCs. Although the sample size was relatively small, FGF3/FGF4 amplification, a poorly differentiated histological type, and multiple lung metastas… (full text at CIViC) PMID 22890726 · Arao et al., 2013 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID13274 Among 26 cancer cell lines tested for growth inhibition by sorafenib, KYSE220 was the only FGF3/FGF4-amplified cell line and showed marked sorafenib sensitivity, with an IC50 of 0.18 μM. PMID 22890726 · Arao et al., 2013 · Open in CIViC	civic

FGF4 Amplification2
Sorafenib	Hepatocellular Carcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID13273 In a retrospective analysis of sorafenib-treated hepatocellular carcinoma, FGF3/FGF4 co-amplification was detected in 3 of 10 evaluable tumors from patients with complete or partial responses and in 0… (full text at CIViC) PMID 22890726 · Arao et al., 2013 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID13275 Among 26 cancer cell lines tested for growth inhibition by sorafenib, KYSE220 was the only FGF3/FGF4-amplified cell line and showed marked sorafenib sensitivity, with an IC50 of 0.18 μM. PMID 22890726 · Arao et al., 2013 · Open in CIViC	civic

FLT3 ITD3
Sorafenib	Leukemia	Predictive	D	Does Not Support Sensitivity Response	5	rejected	EID7372 In a preclinical trial, MV4-11 leukemic cell lines with the FLT3-ITD mutation and RS4;11 leukemic cell lines with the native FLT3 gene were treated with the tyrosine kinase inhibitors (TKI) ponatinib,… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic
〃	Leukemia	Predictive	D	Supports Sensitivity Response	5	rejected	EID7373 In a preclinical trial, MV4-11 leukemic cell lines with the FLT3-ITD mutation and RS4;11 leukemic cell lines with the native FLT3 gene were treated with the tyrosine kinase inhibitors (TKI) ponatinib,… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic
Sorafenib + SunitinibSubstitutes	Leukemia	Predictive	D	Supports Sensitivity Response	4	accepted	EID7382 In a preclinical trial, the leukemic cell line MV4-11 with the FLT3-ITD mutation and the leukemic cell line RS4;11 with the native FLT3 gene were treated with the tyrosine kinase inhibitors (TKI) pona… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic

ARAF S214C2
Sorafenib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID17 In one patient with S214C mutation, the use of sorafenib has led to more than 5 years of survival and near remission. PMID 24569458 · Imielinski et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID40 Sorafenib can inhibit ARF-mediated MEK phosphorylation and soft agar colony formation of AALE cells expressing ARAF S214C in vitro. PMID 24569458 · Imielinski et al., 2014 · Open in CIViC	civic

BRAF V600E6
Cetuximab + SorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID2894 Cetuximab or panitumumab may be ineffective in patients with BRAF mutation unless BRAF inhibitor such as Sorafenib is introduced. PMID 19001320 · Di Nicolantonio et al., 2008 · Open in CIViC	civic
Panitumumab + SorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID89 Cetuximab or panitumumab may be ineffective in patients with BRAF mutation unless BRAF inhibitor such as Sorafenib is introduced. PMID 19001320 · Di Nicolantonio et al., 2008 · Open in CIViC	civic
Sorafenib	Malignant Thyroid Gland Neoplasm	Predictive	B	Supports Sensitivity Response	—	rejected	EID2504 In a study of 102 papillary thyroid cancer patients with a 15 year median follow-up time, those with BRAF V600E mutations had reduced overall survival compared to those with wildtype BRAF (P=0.015, lo… (full text at CIViC) PMID 18682506 · Elisei et al., 2008 · Open in CIViC	civic
〃	Malignant Thyroid Gland Neoplasm	Predictive	D	Supports Sensitivity Response	—	submitted	EID2142 Following treatment with sorafenib, thyroid cancer cell lines with BRAF V600E mutations had severely reduced proliferation rates, but cells with wildtype BRAF were insensitive (P<0.0001). PMID 16533790 · Salvatore et al., 2006 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Sensitivity Response	—	submitted	EID2122 In a mouse in vivo study, the dual RAF and VEGF inhibitor sorafenib suppressed the growth of both UACC903 and 1205Lu cell line- generating xenograft tumors harboring the BRAF-V600E mutation, which ha… (full text at CIViC) PMID 15781657 · Sharma et al., 2005 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Sensitivity Response	—	submitted	EID2123 An inducible BRAF-V600E mouse melanoma model has shown a tight correlation between activated BRAF and disease progression. PMID 16424035 · Hoeflich et al., 2006 · Open in CIViC	civic

BRAF Fusion2
Bevacizumab + Sorafenib + TemsirolimusCombination	Spindle Cell Sarcoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1664 A patient with a malignant spindle cell tumor of the chest wall treated as a soft tissue sarcoma was identified to harbor a KIAA1549-BRAF fusion. This patient responded to treatment with the pan-kinas… (full text at CIViC) PMID 24422672 · Subbiah et al., 2014 · Open in CIViC	civic
〃	Spindle Cell Sarcoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID7312 A patients with malignant spindle cell tumor treated as as soft tissue sarcoma harboring KIAA1549-BRAF fusion were treated with sorafenib in combination with bevacizumab and temsirolimus. Tumor of th… (full text at CIViC) PMID 26314551 · Ross et al., 2016 · Open in CIViC	civic