CTD 1.9
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1 CTD 1.9
2
3 (1) JAN JAN Bortezomib {(1R)-3--1-[(2S)-3--2-(-2-)] () } {(1R)-3-Methyl-1-[(2S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido]butyl}boronic acid (2) INN bortezomib Recommended INN List 50, WHO Drug Information, Vol. 17, No. 4, 03 (3) N N O N H H H N O H 3 C OH B OH H CH 3
4
5 CTD 1.10
6
7
8 {(1R)-3-Methyl-1-[(2S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido]butyl} boronic acid O H N N H N H N O H 3 C OH B OH H CH mg/m ~ ~35 5 1
9 mg/kg , 0, 0.10, 0., 0.25 mg/kg/ mg/kg/ 0. mg/kg/ 0.25 mg/kg/ 26 9, 0, 0.05, 0.10, 0.10 mg/kg/ 0./0.15 mg/kg/ 0./0.15 mg/kg/ 0.05 mg/kg/ 0.10 mg/kg/ mg/kg/ mg/kg/ 0./0.15 mg/kg/ 4, 0, 0.045, mg/kg/ mg/kg/ , mg/kg/ mg/kg/ mg/kg/ mg/kg/ 38 13, 0, 0.050, 0.075, mg/kg/ mg/kg/ mg/kg/ / mg/kg/ mg/kg/ mg/kg/ mg/kg/ mg/kg/
10 /16=100% I/II I AST 4 6 ALT4
11 3 mg CTD 1.12
12
13 S S 3.2.P P (3.0mg 3.2.A 3.2.R P (3.5mg)
14 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : Selectivity of PS-341 for inhibition of the S proteasome Kinetic evaluation of PS-341, PS-273, and PS- 304 et al, 19 LeukoSite, 166 RPT Summary report : MYO The proteasome inhibitor PS-341 inhibits Kenneth C growth, induces apoptosis, and overcomes drug Anderson resistance in human multiple myeloma cells Assay for potential drug resistance mechanisms of PS-341 Development and characterization of PS-341- resistant multiple myeloma cell lines Effect of PS-341 on paraprotein levels in multiple myeloma cells in vitro et al, 01.2 Harvard Medical School Cancer Research 01; 61: RPT RPT RPT
15 Proteasome inhibitor PS-341 inhibits human myeloma cell growth in vivo and prolongs survival in a murine model A study to examine effects of PS-341 in the Lewis lung carcinoma model, including tumor volume, S proteasome activity, survival, and uptake of 14 C-PS-341 Effect of the proteasome inhibitor PS-341 in the Lewis lung carcinoma mouse model Effect of the proteasome inhibitor PS-341 in the human colon HT-29 cancer model Effects of PS-341 on hematopoietic stem cell function in a murine bone marrow transplant model S proteasome activity analysis of PS-341 drug substance impurities Western blot analysis for the presence of proteinase K-resistant forms of prion protein after proteasome inhibition of neuronal cell lines in vitro Kenneth C Anderson et al et al Harvard Medical School Cancer Research 02; 62: RPT ProScript, Pcol-05-01,, 19 ProScript, Pcol RPT RPT RPT JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
16 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : Single dose intravenous safety pharmacology study in the rat: The modified Irwin's test Cardiovascular effects of bortezomib in conscious, telemetered beagle dogs PS-341: Cardiovascular effects after intravenous administration in telemetered cynomolgus monkeys Cardiotoxicity of PS-341 (NSC-D681239) in the monkey (G465502A) A study to determine the effects of PS-341 on cardiovascular function after intravenous administration to anesthetized cynomolgus monkeys Effects of velcade (bortezomib; JNJ AAA) on the membrane K + current (I kr ) in herg-transfected HEK293 cells compared to al astemizole [proteasome inhibitor; Dip 999] Study of the effects of escalating concentrations of bortezomib on cardiovascular function in the guinea pig Langendorff preparation et al,, et Janssen Pharmaceutica NV Janssen Pharmaceutica NV TOX6579 TOX A 191 CPF1223 DSD
17 Investigative cardiovascular safety study following intravenous administration of bortezomib in telemetered male beagle dogs Investigative cardiovascular study of the proteasome inhibitor PS-341 in the mouse Effects of bortezomib on respiration rate and tidal volume in rats et al al The proteasome inhibitor PS-341 markedly enhances sensitivity of multiple myeloma tumor cells to chemotherapeutic agents,, et James R Berenson The proteasome inhibitor PS-341 inhibits Kenneth C growth, induces apoptosis, and overcomes drug Anderson resistance in human multiple myeloma cells Effect of the proteasome inhibitor PS-341 in the Lewis lung carcinoma mouse model Enhanced chemosensitivity to CPT-11 with proteasome inhibitor PS-341: Implications for systemic nuclear factor-b inhibition al, et James C Cusack Jr Cedars-Sinai Medical Center Harvard Medical School DSD RPT TOX6675 Clinical Cancer Research 03; 9: Cancer Research 01; 61: ProScript, Pcol Massachusetts General Hospital Cancer Research 01; 61: JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
18 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : Validation of a method for the determination of PS-341 in rat plasma and whole blood and cynomolgus monkey plasma and whole blood by high-performance liquid chromatography with MS/MS detection Partial validation for the quantitation of PS-341 in rat plasma by turbo ion spray LC/MS/MS Partial validation for the quantitation of PS-341 in rabbit plasma by turbo ion spray LC/MS/MS Validation of a method for the determination of PS-341 cynomolgus monkey plasma by highperformance liquid chromatography with MS/MS detection Partial validation for the quantitation of PS-341 in monkey plasma by turbo ion spray LC/MS/MS A B 043 8
19 Single dose intravenous toxicity and toxicokinetic study with PS-341 in rats Biliary excretion of PS-341 in cynomolgus monkeys following a single intravenous dose of [ 14 et al C]-PS-341 Toxicokinetic study report supporting an intravenous injection range-finding teratology study of PS-341 in the Sprague-Dawley rat Toxicokinetic study report supporting a 26- week intravenous injection toxicity study of PS-341 in the Sprague-Dawley rat (final data) Toxicokinetic study supporting an IV rangefinding teratology study of PS-341 in New Zealand White rabbit Toxicokinetic study report supporting a 38- week (13 cycles) intravenous injection toxicity study of PS-341 in the cynomolgus monkey al, et, RPT RPT RPT RPT JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
20 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : A study to examine effects of PS-341 in the Lewis lung carcinoma model, including tumor volume, S proteasome activity, survival, and uptake of 14 C-PS-341 Quantitative whole body autoradiography in male rats after a single intravenous administration of approx. 0.3 mg/kg body weight Tissue distribution, biliary excretion, and mass balance of 14 C-PS-341 in male Sprague Dawley rats following a single bolus intravenous dose Tissue distribution and depletion kinetics in male rats after single and repeated intravenous injection of 14 C-bortezomib Biliary excretion of PS-341 in cynomolgus monkeys following a single intravenous dose of [ 14 et al C]-PS-341 Tissue distribution and mass balance of total radioactivity in male and female cynomolgus monkeys following a single bolus intravenous dose of 14 C-PS-341 The protein binding of bortezomib in plasma from rats, dogs, and monkeys al, et, Janssen Pharmaceutica, NV RPT /1 800 FK FK
21 The in vitro protein binding of [ 14 C]-PS-341 to plasma from rat, monkey, and human Partition of PS-341 between plasma and red blood cells in the cynomolgus monkey and Sprague-Dawley rat Partition of PS-341 between human red blood cells and plasma Distribution of [ 14 C]-bortezomib in Sprague- Dawley rat whole blood A study of the pharmacokinetics of bortezomib following repeated intravenous administration to male cynomolgus monkeys In vitro metabolic stability of PS-341 in mouse and human microsomes Preliminary identification of PS-341 biliary excreted metabolites in rats treated with a single intravenous bolus dose of [ 14 C]-PS-341 Structural elucidation of PS-341 metabolites produced in vitro by human liver microsomes and cdna-expressed cytochrome P450 isozymes et al, RPT RPT RPT-007 RPT RPT RPT RPT JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
22 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : In vitro metabolism of PS-341 by human CYP isozymes The relative contribution of CYP isozymes to the metabolism of bortezomib in human liver microsomes using monoclonal antibodies Relative contribution of CYP isozymes to the liver microsomal intrinsic clearance of bortezomib in humans Identification and characterization of PS-341 metabolites in Sprague-Dawley rats Distribution of [ 14 C]-bortezomib in Sprague- Dawley rat whole blood Tissue distribution and depletion kinetics in male rats after single and repeated intravenous injection of 14 C-bortezomib Identification and characterization of PS-341 metabolites in cynomolgus monkeys Radiochemical profiles of brain extracts of cynomolgus monkeys dosed with 14 C- bortezomib RPT RPT RPT RPT RPT FK RPT RPT
23 Characterization of [ 14 C]-bortezomib and metabolites in cynomolgus monkey tissues Identification and characterization of PS-341 metabolites in humans Inhibition potential of PS-341 on CYP1A2, 2C9, 2C19, 2D6, and 3A4 in the human microsomal system Inhibition potential of the major bortezomib metabolites on CYP1A2, 2C9, 2C19, 2D6 and 3A4 activities in human liver microsomes Time-dependent inhibition potential of bortezomib on human microsomal CYP3A4 activity Evaluation of cytochrome P450 induction potential of PS-341 using cultured human hepatocytes Characterization of CYP2B1/2, 3A1/2, 4A1/3 and peroxisomal B-oxidation activities in female Sprague-Dawley rat liver after repeated intravenous administration of bortezomib Biliary excretion of PS-341 in male rats following a single intravenous dose of [ 14 C]- PS-341 et al, RPT-006 RPT RPT RPT RPT RPT RPT JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
24 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : Tissue distribution, biliary excretion, and mass balance of 14 C-PS-341 in male Sprague Dawley rats following a single bolus intravenous dose Biliary excretion of PS-341 in cynomolgus monkeys following a single intravenous dose of [ 14 et al C]-PS-341 Tissue distribution and mass balance of total radioactivity in male and female cynomolgus monkeys following a single bolus intravenous dose of 14 C-PS Permeability of PS-341 and its interaction with efflux pumps in vitro in the Caco-2 cell system Permeability of bortezomib and its interaction with efflux pumps in vitro in the Caco-2 cell system Multiple dose toxicity study of PS-341 (NSC ) in rats An intravenous injection range-finding teratology study of PS-341 in the Sprague- Dawley rat: S proteasome specific activity RPT RPT RPT
25 Week intravenous toxicity study with PS-341 in cynomolgus monkeys An analysis of proteasome activity in peripheral whole blood in albino rats in a 26-week intravenous injection toxicity study of PS-341 An analysis of peripheral whole blood for the determination of S proteasome activity in the intravenous range-finding teratology study of PS-341 in the New Zealand White rabbit A study of the pharmacokinetics of bortezomib following repeated intravenous administration to male cynomolgus monkeys Toxicokinetic study report supporting a 38- week (13 cycles) intravenous injection toxicity study of PS-341 in the cynomolgus monkey Pilot toxicity studies in mice and rats: Single and repeat doses of the proteasome inhibitor PS-341 Single dose intravenous toxicity and toxicokinetic study with PS-341 in rats al RPT RPT RPT RPT ProScript, Pcol-04-01, et JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
26 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ : Range-finding intravenous toxicity study with PS-341 in cynomolgus monkeys 24-Hour continuous infusion dose rangefinding study of PS-341 (NSC ) in monkeys Multiple dose toxicity study of PS-341 (NSC ) in rats INTERIM RESEARCH REPORT: A 26-week intravenous injection toxicity study of PS-341 in the albino rat A 26-week intravenous injection toxicity study of PS-341 in the albino rat A 13-day daily intravenous injection rangefinding toxicity study of PS-341 in the female New Zealand White rabbit 14-Day intravenous toxicity study with PS-341 in cynomolgus monkeys 4-Week intravenous toxicity study with PS-341 in cynomolgus monkeys A 38-week (13-cycle) intravenous injection toxicity study of PS-341 in the cynomolgus monkey al al al, et, et, et
27 In Vitro Salmonella plate incorporation mutagenicity assay (Ames test) with a confirmatory assay et al, Bacterial reverse mutation assay with PS-341, et al In vitro mammalian chromosome aberration test in Chinese hamster ovary cells In Vivo Mammalian erythrocyte micronucleus test in mice An intravenous injection range-finding teratology study of PS-341 in the Sprague- Dawley rat An intravenous injection teratology study of PS-341 in the Sprague-Dawley rat JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29
28 JEDI_DEV00 \ 0900fde9800d3570 \ 1.26 \ Approved \ :29 An intravenous range-finding teratology study of PS-341 in the New Zealand White rabbit An intravenous teratology study of PS-341 in the New Zealand White rabbit A perivascular / intravascular, subcutaneous, and intramuscular irritation study with PS-341 in male New Zealand White rabbits An antigenicity study with VELCADE; determination of the active systemic anaphylaxis (ASA) and passive cutaneous anaphylaxis (PCA) in guinea pigs A 28-day IP administration immunotoxicology study of PS-341 in the female BALB/c mouse al al al, et 57360, et 6287, et RPT
29 J ( BA BA BE In VitroIn Vivo Development and Validation of a LC/MS Analytical Assay For Determination of PS-341 in Biological Fluids Method Validation for the Quantitation of PS- 341 in Human Plasma by Turbo Ion Spray LC/MS/MS Accurate Measurement of Proteasome Inhibition: Novel Ex Vivo Assays et al, Report No. 002VDAC_MP_REV 1.DOC File No. 167
30 The In Vitro Protein Binding of [ 14 C]-PS-341, Study No. to Plasma from Rat, Monkey, and Human et al Structural Elucidation of PS-341 Metabolites Produced In Vitro by Human Liver Microsomes and cdna-expressed Cytochrome Report No. RPT P450 Isozymes In Vitro Metabolism of PS-341 by Human CYP Isozymes The Relative Contribution of CYP Isozymes to the Metabolism of Bortezomib in Human Liver Microsomes Using Monoclonal Antibodies Relative Contribution of CYP Isozymes to the Liver Microsomal Intrinsic Clearance of Bortezomib in Humans Inhibition Potential of PS-341 on CYP1A2, 2C9, 2C19, 2D6, and 3A4 in the Human Microsomal System Inhibition Potential of the Major Bortezomib Metabolites on CYP1A2, 2C9, 2C19, 2D6, and 3A4 Activities in Human Liver Microsomes Report No. RPT Report No. RPT Report No. RPT Report No. RPT Report No. RPT J
31 J Time-Dependent Inhibition Potential of Bortezomib on Human Microsomal CYP3A4 Activity Evaluation of Cytochrome P450 Induction Potential of PS-341 Using Cultured Human Hepatocytes Partition of PS-341 Between Human Red Blood Cells and Plasma Permeability of PS-341 and its Interaction with Efflux Pumps In Vitro in the Caco-2 Cell System Permeability of Bortezomib and its Interaction with Efflux Pumps In Vitro in the Caco-2 Cell System Identification and Characterization of PS-341 Metabolites in Humans PK PK PK 21 Report No. RPT Report No. RPT Report No. RPT Report No. RPT Report No. RPT Report No. RPT
32 PK PK PK PD PD PK/PD PD PK/PD JNJ (bortezomib) Protocol Number I/II JNJ JPN- MM Phase 1 Trial of PS-341 in Advanced Cancers, et al Phase I Trial of PS-341 in Advanced Malignancy MD Anderson Cancer Center Memorial Sloan- Kettering Cancer Center 22 Protocol Number DM Protocol Number A J
33 J Phase 1 Evaluation of PS-341 in Patients with Hematologic Malignancies A Phase I, Open Label, Dose Escalation Study of PS-341 plus Gemcitabine in Patients with Advanced Solid Tumors A Randomized, Open-Label, Phase II Study of Two Doses of PS-341 Alone or in Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Failed to Respond to or Relapsed Following Front-line Therapy An Open-Label Phase II Study of PS-341 Alone or in Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Relapsed Following Front-Line Therapy and Are Refractory totheir Most Recent Therapy Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma [INTERIM CLINICAL STUDY REPORT] al et al et al, et,, University of North Carolina H Lee Moffitt Cancer Center & Research Institute St. Vincent's Comprehensive Cancer Center Dana Farber Cancer Institute Protocol Number LCCC 9834 / MSKCC Protocol Number M Protocol Number M Protocol Number M Ongoing Protocol Number M
34 An International, Multi-Center, Randomized, Open-Label Study of PS-341 Versus High Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma Dana Farber Cancer Institute Protocol Number M A Randomized, Open-Label, Phase II Study of Two Doses of PS-341 Alone or in Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Failed to Respond to or Relapsed Following Front-line Therapy An Open-Label Phase II Study of PS-341 Alone or in Combination with Dexamethasone in Patients with Multiple Myeloma Who Have Relapsed Following Front-Line Therapy and Are Refractory totheir Most Recent Therapy et al, St. Vincent's Comprehensive Cancer Center Dana Farber Cancer Institute JNJ (bortezomib) I/II Protocol Number JNJ JPN- MM-101 JNJ (bortezomib) Protocol Number JNJ JPN- MM-1 24 Protocol Number M Protocol Number M J
35 J A Phase 2, Open-Label, Extension Study to Provide PS-341 to Patients Who Previously Participated in a PS-341 Clinical Study and Who may Benefit from Re-Treatment with or Continuation of PS-341 Therapy Phase 1 Trial of PS-341 in Advanced Cancers, et al Phase I Trial of PS-341 in Advanced Malignancy Phase 1 Evaluation of PS-341 in Patients with Hematologic Malignancies al, et Reports of Analyses of Data from More Than One Study, Phase I and Phase II Review of the Frequency, Severity and Reversibility of Treatment-Emergent Peripheral Neuropathy during Treatment with VELCADE in Multiple Myeloma Studies M , M and the Follow-on Study M MD Anderson Cancer Center MD Anderson Cancer Center Memorial Sloan- Kettering Cancer Center University of North Carolina 25 Protocol Number M Protocol Number DM Protocol Number A Protocol Number LCCC 9834 / MSKCC 00-31
36 NDA Module 5 Clinical Study Reports Reports of Postmarketing Experience Periodic Safety Update Report 26 April 04 to 25 October 04 Periodic Safety Update Report 26 October 04 to 25 April SOC Dana Farber 02.5 Cancer Institute Protocol Number M Protocol Number JNJ JPN- MM , et al St. Vincent's Comprehensive Cancer Center Dana Farber Cancer Institute 26 Protocol Number M Protocol Number M J
37 J , et MD Anderson al Cancer Center Protocol Number M JNJ JNJ
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