Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	5327	1346242-81-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: erdafitinib balversa JNJ-42756493 G-024	Erdafitinib inhibited FGFR phosphorylation and signaling and decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions. Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer. Molecular weight: 446.56 Formula: C25H30N6O2 CLOGP: 4.34 LIPINSKI: 0 HAC: 8 HDO: 1 TPSA: 77.33 ALOGS: -4.53 ROTB: 9 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

erdafitinib
balversa
JNJ-42756493
G-024

Erdafitinib inhibited FGFR phosphorylation and signaling and decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions. Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer.

Molecular weight: 446.56
Formula: C25H30N6O2
CLOGP: 4.34
LIPINSKI: 0
HAC: 8
HDO: 1
TPSA: 77.33
ALOGS: -4.53
ROTB: 9

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
9	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	2.390		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	1.995		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	18.450	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	14.191	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	15.610	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	36.530	%	High	1
herg	hERG pIC50	5.593	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	5.572	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	20.654	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	11.740	%	High	1
kinase-safety-class	ACVR2B,ACVRL1,AURKB,AXL,BRAF,CAMK2D,CDK9,CSF1R,DDR1,EGFR,EIF2AK3,ERBB2,FLT3,GAK,GRK2,IRAK1,IRAK3,ITK,KDR,KIT,LCK,MAP3K1,MAP3K21,MAP4K1,MAP4K3,MAP4K5,MAPK7,MET,NTRK1,PDK1,PDK2,PDK4,PIK3CA,PIK3CD,PRKDC,RIPK3,SIK2,SIK3,SRC,TGFBR1,TNIK	41
kinase-selectivity-class	ACVRL1,CSF1R,FLT4,KDR,LYN,PDK4	6
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	4.406		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	37.670		High	1
mppb	Mouse plasma protein binding (% unbound)	12.280		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	21.627		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	23.730	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	27.040	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	37.870	%	High	1
rppb	Rat plasma protein binding (% unbound)	15.520	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	605.341	uM	High	1

Approvals:

Date	Agency	Company	Orphan
April 12, 2019	FDA	JANSSEN BIOTECH

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Onycholysis	85.04	54.25	14	475	2216	90625742
Hyperphosphataemia	84.54	54.25	15	474	3696	90624262

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Onycholysis	106.51	52.41	17	496	988	42619834
Nail disorder	73.22	52.41	14	499	2313	42618509
Death	68.78	52.41	51	462	471134	42149688
Hyperphosphataemia	53.81	52.41	15	498	12989	42607833

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Onycholysis	151.90	57.70	25	823	2774	110585677
Hyperphosphataemia	86.89	57.70	21	827	16360	110572091
Nail discolouration	67.01	57.70	13	835	3622	110584829

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EN01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000185506	Cytochrome P450 3A4 Inducers
FDA MoA	N0000187061	Organic Cation Transporter 2 Inhibitors
FDA MoA	N0000194026	Fibroblast Growth Factor Receptor Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agent

Related Drugs by ATC class:

L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors 3 drugs

futibatinib infigratinib pemigatinib

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Metastatic urothelial carcinoma	indication	458321000124102

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.52	Basic
pKa2	2.13	Basic
pKa3	0.47	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	9464071	April 28, 2031	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	9464071	April 28, 2031	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	9464071	April 28, 2031	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	12037644	Oct. 18, 2035	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	12037644	Oct. 18, 2035	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	12037644	Oct. 18, 2035	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10898482	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC, SURGICALLY UNRESECTABLE UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11684620	Feb. 9, 2036	TREATMENT OF ADULTS WITH METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10478494	Aug. 13, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PRIOR PD-1 OR PD-L1 INHIBITOR THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10478494	Aug. 13, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PRIOR PD-1 OR PD-L1 INHIBITOR THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	10478494	Aug. 13, 2036	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PRIOR PD-1 OR PD-L1 INHIBITOR THERAPY
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	11077106	Feb. 2, 2038	TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
3MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	Jan. 19, 2027	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (MUC) WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
4MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	Jan. 19, 2027	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (MUC) WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
5MG	BALVERSA	JANSSEN BIOTECH	N212018	April 12, 2019	RX	TABLET	ORAL	Jan. 19, 2027	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (MUC) WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Vascular endothelial growth factor receptor 2	Kinase	P35968	VGFR2_HUMAN	INHIBITOR	IC50	7.43	SCIENTIFIC LITERATURE	DRUG LABEL
Fibroblast growth factor receptor 3	Kinase	P22607	FGFR3_HUMAN	INHIBITOR	IC50	8.52	SCIENTIFIC LITERATURE	DRUG LABEL
Fibroblast growth factor receptor 1	Kinase	P11362	FGFR1_HUMAN	INHIBITOR	IC50	8.92	SCIENTIFIC LITERATURE	DRUG LABEL
Fibroblast growth factor receptor 2	Kinase	P21802	FGFR2_HUMAN	INHIBITOR	IC50	8.60	SCIENTIFIC LITERATURE	DRUG LABEL
Fibroblast growth factor receptor 4	Kinase	P22455	FGFR4_HUMAN	INHIBITOR	IC50	8.24	SCIENTIFIC LITERATURE	DRUG LABEL
Vascular endothelial growth factor receptor 2	Kinase		VGFR2_MOUSE		IC50	10	CHEMBL

External reference:

ID	Source
890E37NHMV	UNII
4038332	VANDF
C4519323	UMLSCUI
CHEBI:232556	CHEBI
CHEMBL3545376	ChEMBL_ID
67462786	PUBCHEM_CID
DB12147	DRUGBANK_ID
D10927	KEGG_DRUG
10147	INN_ID
C000604580	MESH_SUPPLEMENTAL_RECORD_UI
9039	IUPHAR_LIGAND_ID
787731007	SNOMEDCT_US
787742003	SNOMEDCT_US
5SF	PDB_CHEM_ID
314002	MMSL
36736	MMSL
d09237	MMSL
017965	NDDF
2123125	RXNORM
890E37NHMV	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-030	TABLET, FILM COATED	3 mg	ORAL	NDA	30 sections
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-030	TABLET, FILM COATED	3 mg	ORAL	NDA	30 sections
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-040	TABLET, FILM COATED	4 mg	ORAL	NDA	30 sections
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-040	TABLET, FILM COATED	4 mg	ORAL	NDA	30 sections
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-050	TABLET, FILM COATED	5 mg	ORAL	NDA	30 sections
BALVERSA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-050	TABLET, FILM COATED	5 mg	ORAL	NDA	30 sections

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erdafitinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: