Glofitamab

Highest phase reached
Drug type
First approval year

First approval year
Listing at source
Listed
Highest phase reached

Drug type
Drug name
Glofitamab

  • columvi
  • Columvi

  • anti cd20 cd3 bispecific monoclonal antibody ro7082859
  • ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859
  • columvi
  • Columvi
  • columvi 10 mg concentrate for solution for infusion
  • glofitamab
  • Glofitamab
  • glofitamab [INN]
  • Glofitamab [MI]
  • GLOFITAMAB [USAN]
  • Glofitamab [WHO-DD]
  • glofitamab gxbm
  • Glofitamab gxbm [WHO-DD]
  • glofitamab gxbm who dd
  • glofitamab inn
  • glofitamab mi
  • glofitamab usan
  • glofitamab who dd
  • Glofitamab-gxbm
  • IMMUNOGLOBULIN G1 (149-GLUTAMIC ACID,215-GLUTAMIC ACID,461-ALANINE,462-ALANINE,556-GLYCINE,581-CYSTEINE,593-TRYPTOPHAN), ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 VH-CH1 FRAGMENT) FUSION PROTEIN WITH PEPTIDE (SYNTHETIC 10-AMINO ACID LINKER) FUSION PROTEIN WITH IMMUNOGLOBULIN ANTI-(HUMAN CD3 ANTIGEN .EPSILON.-CHAIN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 HEAVY CHAIN VL(.LAMBDA.)-CH1-CH2-CH3), (222->219''')-DISULFIDE WITH IMMUNOGLOBULIN ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .KAPPA.-CHAIN (128-ARGININE,129-LYSINE)) AND (447->232'')-DISULFIDE WITH IMMUNOGLOBULIN ANTI-(HUMAN CD3 ANTIGEN .EPSILON.-CHAIN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 LIGHT CHAIN VH-CL(.KAPPA.)), (453->228'), (456->231'), (581->351')-TRIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (149-GLUTAMIC ACID,215-GLUTAMIC ACID,236-ALANINE,237-ALANINE,331-GLYCINE,351-CYSTEINE,368-SERINE,370-ALANINE,409-VALINE) ANTI-(HUMAN CD20 ANTIGEN) (HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .GAMMA.1-CHAIN) DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL RG6026 .KAPPA.-CHAIN (128-ARGININE,129-LYSINE)
  • immunoglobulin g1 149 glutamic acid 215 glutamic acid 461 alanine 462 alanine 556 glycine 581 cysteine 593 tryptophan anti human cd20 antigen human mus musculus monoclonal rg6026 vh ch1 fragment fusion protein with peptide synthetic 10 amino acid linker fusion protein with immunoglobulin anti human cd3 antigen epsilon chain human mus musculus monoclonal rg6026 heavy chain vl lambda ch1 ch2 ch3 222 219 disulfide with immunoglobulin anti human cd20 antigen human mus musculus monoclonal rg6026 kappa chain 128 arginine 129 lysine and 447 232 disulfide with immunoglobulin anti human cd3 antigen epsilon chain human mus musculus monoclonal rg6026 light chain vh cl kappa 453 228 456 231 581 351 tris disulfide with immunoglobulin g1 149 glutamic acid 215 glutamic acid 236 alanine 237 alanine 331 glycine 351 cysteine 368 serine 370 alanine 409 valine anti human cd20 antigen human mus musculus monoclonal rg6026 gamma 1 chain disulfide with human mus musculus monoclonal rg6026 kappa chain 128 arginine 129 lysine
  • immunoglobulin g1 lambda kappa with domain cross over anti homo sapiens ms4a1 membrane spanning 4 domains subfamily a member 1 cd20 and anti homo sapiens cd3e cd3 epsilon leu 4 monoclonal antibody bispecific trivalentgamma lambda heavy chain anti ms4a1 and anti cd3e vh ch1 v lambda ch1 ch2 ch3 1 674 humanized vh anti ms4a1 homo sapiens ighv1 69 02 84 7 ighd ighj4 01 100 8 8 12 1 119 homo sapiens ighg1 01 g1m17 ch1 k26 e 149 k119 e 215 k120 216 120 217 hinge 1 6 218 223 120 223 10 mer bis tetraglycyl seryl linker 224 233 v lamdda anti cd3e mus musculus iglv1 01 81 2 iglj1 01 100 homo sapiens iglv7 46 01 80 0 iglj3 01 100 9 3 9 234 342 2 mer biseryl linker 343 344 homo sapiens ighg1 01 g1m17 g1m1 ch1 k120 441 345 442 hinge 1 15 443 457 ch2 l1 3 a 461 l1 2 a 462 p114 g 556 458 567 ch3 s10 c 581 d12 583 l14 585 t22 w 593 568 672 chs 673 674 345 674 222 219 disulfide with kappa light chain humanized anti ms4a1 1 219 humanized v kappa homo sapiens igkv2 28 01 87 0 igkj4 01 100 11 3 9 1 112 homo sapiens igkc 01 98 1 e12 r 128 q13 k 129 km3 a45 1 158 v101 196 113 219 447 232 disulfide with vh c kappa light chain humanized anti cd3e 1 232 humanized vh homo sapiens ighv3 23 03 87 0 igkj6 01 90 9 8 10 16 1 125 homo sapiens igkc 01 99 1 t1 3 s 127 km3 a45 1 171 v101 209 126 232 gamma1 heavy chain humanized anti ms4a1 1 449 humanized vh homo sapiens ighv1 69 02 84 7 ighd ighj4 01 100 8 8 12 1 119 homo sapiens ighg1 01 g1m17 1 ch1 k26 e 149 k119 e 215 k120 216 120 217 hinge 1 15 218 232 ch2 l1 3 a 236 l1 2 a 237 p114 g 331 233 342 ch3 y5 c 351 d12 358 l14 360 t22 s 368 l24 a 370 y86 v 409 343 447 chs 448 449 120 449 222 219 disulfide with kappa light chain humanized anti ms4a1 1 219 humanized v kappa homo sapiens igkv2 28 01 87 0 igkj4 01 100 11 3 9 1 112 homo sapiens igkc 01 98 1 e12 r 128 q13 k 129 km3 a45 1 158 v101 196 113 219 dimer 453 228 456 231 581 351 trisdisulfide
  • IMMUNOGLOBULIN G1-LAMBDA/KAPPA WITH DOMAIN CROSS-OVER, ANTI-(HOMO SAPIENS MS4A1 (MEMBRANE-SPANNING 4-DOMAINS SUBFAMILY A MEMBER 1, CD20)) AND ANTI-(HOMO SAPIENS CD3E (CD3 EPSILON, LEU-4)) MONOCLONAL ANTIBODY, BISPECIFIC, TRIVALENTGAMMA-LAMBDA HEAVY CHAIN ANTI-MS4A1 AND ANTI-CD3E (VH-CH1-V-LAMBDA-CH1-CH2-CH3) (1-674) (HUMANIZED VH ANTI-MS4A1 (HOMO SAPIENS IGHV1-69*02 (84.7%)-(IGHD)-IGHJ4*01 (100%)) (8.8.12) (1-119)-HOMO SAPIENS IGHG1*01, G1M17 (CH1 K26>E (149), K119>E (215), K120 (216) (120-217), HINGE 1-6 (218-223)) (120-223)-10-MER BIS(TETRAGLYCYL-SERYL) LINKER (224-233)-V-LAMDDA ANTI-CD3E (MUS MUSCULUS IGLV1*01 (81.2%)-IGLJ1*01 (100%)/HOMO SAPIENS IGLV7-46*01 (80.0%)-IGLJ3*01 (100%)) (9.3.9) (234-342)-2-MER BISERYL LINKER (343-344)-HOMO SAPIENS IGHG1*01, G1M17, G1M1 (CH1 K120 (441) (345-442), HINGE 1-15 (443-457), CH2 L1.3>A (461), L1.2>A (462), P114>G (556) (458-567), CH3 S10>C (581), D12 (583), L14 (585), T22>W (593) (568-672), CHS (673-674)) (345-674)), (222-219')-DISULFIDE WITH KAPPA LIGHT CHAIN HUMANIZED ANTI-MS4A1 (1'-219') (HUMANIZED V-KAPPA (HOMO SAPIENS IGKV2-28*01 (87.0%)-IGKJ4*01 (100%)) (11.3.9) (1'-112')-HOMO SAPIENS IGKC*01 (98.1%), E12>R (128), Q13>K (129), KM3 A45.1 (158), V101 (196) (113'-219'))(447-232''')-DISULFIDE WITH VH-C-KAPPA LIGHT CHAIN HUMANIZED ANTI-CD3E (1'''-232''') (HUMANIZED VH (HOMO SAPIENS IGHV3-23*03 (87.0%)-IGKJ6*01 (90.9%)) (8.10.16) (1'''-125''')-HOMO SAPIENS IGKC*01 (99.1%), T1.3>S (127), KM3 A45.1 (171), V101 (209) (126'''-232''')), GAMMA1 HEAVY CHAIN HUMANIZED ANTI-MS4A1 (1''-449'') (HUMANIZED VH (HOMO SAPIENS IGHV1-69*02 (84.7%)-(IGHD)-IGHJ4*01 (100%)) (8.8.12) (1''-119'')-HOMO SAPIENS IGHG1*01, G1M17,1 (CH1 K26>E (149), K119>E (215), K120 (216) (120''-217''), HINGE 1-15 (218''-232''), CH2 L1.3>A (236), L1.2>A (237), P114>G (331) (233''-342''), CH3 Y5>C (351), D12 (358), L14 (360), T22>S (368), L24>A (370), Y86>V (409) (343''-447''), CHS (448''-449'')) (120''-449'')), (222''-219'''')-DISULFIDE WITH KAPPA LIGHT CHAIN HUMANIZED ANTI-MS4A1 (1''''-219'''') (HUMANIZED V-KAPPA (HOMO SAPIENS IGKV2-28*01 (87.0%)-IGKJ4*01 (100%)) (11.3.9) (1''''-112'''')-HOMO SAPIENS IGKC*01 (98.1%), E12>R (128), Q13>K (129), KM3 A45.1 (158), V101 (196) (113''''-219''''))DIMER (453-228'':456-231'':581-351'')-TRISDISULFIDE
  • IV Glofitamab
  • rg 6026

And 8 more, listed on the interactive page.

ATC classification codes
  • L01FX28
Sources for recorded values
CAS registry numbers
  • 2229047-91-8
ChEMBL ID
CHEMBL4298092
FDA ingredient codes (UNII)
  • 06P3KLK2J8

  • 2639781
  • 2639782

Applicant
GENENTECH INC
Approval date
15 Jun 2023
Application number
BLA761309

Status
Authorised
Status date
7 Jul 2023
Authorisation date
7 Jul 2023
Approved indications
Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Product number
EMEA/H/C/005751
Authorisation holder
Roche Registration GmbH
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
Yes
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Lymphoma, Large B-Cell, Diffuse
European medicines record

Patents
0
Designations
4
First in class
No
Fast track
Yes
Breakthrough designation
No
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
Yes
Availability
Prescription only
Boxed warning
Yes

Pharmacology name
glofitamab
Type
Antibody
Drug name stem
-mab
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

  • Mechanism
    B-lymphocyte antigen CD20 binding agent
    Action type
    BINDING_AGENT
    Target
    B-lymphocyte antigen CD20
    Protein identifier
    P11836
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P04234
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P07766
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P09693
  • Action
    Binding
    Action type
    Binding
    Target
    CD20 (membrane-spanning 4-domains, subfamily A, member 1)
    Gene symbol
    MS4A1
    Protein identifier
    P11836
    Median affinity
    8.32
    Affinity units
    pEC50

  • Mechanism
    B-lymphocyte antigen CD20 binding agent
    Action type
    BINDING AGENT
    Target
    B-lymphocyte antigen CD20
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING AGENT
    Target
    T cell surface glycoprotein CD3

  • Condition
    Lymphoma, Follicular
    Highest recorded phase
    1
    Condition identifier
    EFO:0000096
    Subject identifier
    D008224
  • Condition
    Lymphoma, Large B-Cell, Diffuse
    Highest recorded phase
    4
    Condition identifier
    EFO:0000403
    Subject identifier
    D016403
  • Condition
    Lymphoma
    Highest recorded phase
    3
    Condition identifier
    EFO:0000574
    Subject identifier
    D008223
  • Condition
    Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000616
    Subject identifier
    D009369
  • Condition
    Lymphoma, Non-Hodgkin
    Highest recorded phase
    1
    Condition identifier
    EFO:0005952
    Subject identifier
    D008228
  • Condition
    Lymphoma, Mantle-Cell
    Highest recorded phase
    2
    Condition identifier
    EFO:1001469
    Subject identifier
    D020522

  • Condition identifier
    EFO_0000403
  • Condition identifier
    EFO_0000574
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000616
  • Condition identifier
    EFO_0005952
  • Condition identifier
    EFO_1001469
    Highest recorded phase
    2
  • Condition identifier
    EFO_1001938
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0002083
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0002571
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0004948
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0005070
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0007243
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0015759
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0017604
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0018876
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0018905
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0018906
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0018906
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0018908
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0044889
    Highest recorded phase
    2

Warnings

  • Warning
    Black Box Warning
    Effect
    immune system toxicity

Open Targets warnings

  • Warning
    Black Box Warning
    Effect
    immune system toxicity
    Country
    United States

  • Event
    alanine aminotransferase increased
    Reports
    16
    Reporting signal score
    23.6396
  • Event
    anaemia
    Reports
    19
    Reporting signal score
    15.5759
  • Event
    aspartate aminotransferase increased
    Reports
    14
    Reporting signal score
    20.4399
  • Event
    bacterial infection
    Reports
    12
    Reporting signal score
    35.7362
  • Event
    blood type incompatibility
    Reports
    1
    Reporting signal score
    8.17944
  • Event
    covid-19
    Reports
    17
    Reporting signal score
    35.3799
  • Event
    cytokine release syndrome
    Reports
    89
    Reporting signal score
    479.77
  • Event
    cytomegalovirus infection reactivation
    Reports
    4
    Reporting signal score
    13.8118
  • Event
    diaphragm neoplasm
    Reports
    1
    Reporting signal score
    6.79345
  • Event
    diffuse large b-cell lymphoma
    Reports
    4
    Reporting signal score
    10.5312
  • Event
    diffuse large b-cell lymphoma recurrent
    Reports
    9
    Reporting signal score
    40.8162
  • Event
    disease progression
    Reports
    48
    Reporting signal score
    118.681
  • Event
    disseminated tuberculosis
    Reports
    3
    Reporting signal score
    8.93193
  • Event
    febrile neutropenia
    Reports
    10
    Reporting signal score
    11.5787
  • Event
    hepatic cytolysis
    Reports
    3
    Reporting signal score
    8.10299
  • Event
    hyperpyrexia
    Reports
    7
    Reporting signal score
    24.1642
  • Event
    hypogammaglobulinaemia
    Reports
    3
    Reporting signal score
    6.94462
  • Event
    immune effector cell-associated hlh-like syndrome
    Reports
    1
    Reporting signal score
    8.87253
  • Event
    immune effector cell-associated neurotoxicity syndrome
    Reports
    19
    Reporting signal score
    106.14
  • Event
    infection
    Reports
    9
    Reporting signal score
    6.6718
  • Event
    mantle cell lymphoma
    Reports
    6
    Reporting signal score
    29.3017
  • Event
    neutropenia
    Reports
    24
    Reporting signal score
    30.5136
  • Event
    parainfluenzae virus infection
    Reports
    2
    Reporting signal score
    6.63898
  • Event
    parvovirus infection
    Reports
    2
    Reporting signal score
    8.83738
  • Event
    platelet count decreased
    Reports
    9
    Reporting signal score
    6.72604

And 3 more, listed on the interactive page.

And 5 more, listed on the interactive page.

Dose
1,000 mg
Route
Intravenous
How often
Every 21 days

  • Administer as an intravenous infusion
  • Administer in a healthcare setting with immediate access to medical support

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

  • Component
    Heavy chain 1-674 anti-MS4A1, anti-CD3
    Type
    Protein
    Sequence
    QVQLVQSGAEVKKPGSSVKVSCKASGYAFSYSWINWVRQAPGQGLEWMGRIFPGDGDTDYNGKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNVFDGYWLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVEDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDEKVEPKSCDGGGGSGGGGSQAVVTQEPSLTVSPGGTVTLTCGSSTGAVTTSNYANWVQEKPGQAFRGLIGGTNKRAPGTPARFSGSLLGGKAALTLSGAQPEDEAEYYCALWYSNLWVFGGGTKLTVLSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALGAPIEKTISKAKGQPREPQVYTLPPCRDELTKNQVSLWCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
  • Component
    Heavy chain 1''-449'' anti-MS4A1
    Type
    Protein
    Sequence
    QVQLVQSGAEVKKPGSSVKVSCKASGYAFSYSWINWVRQAPGQGLEWMGRIFPGDGDTDYNGKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNVFDGYWLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVEDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDEKVEPKSCDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALGAPIEKTISKAKGQPREPQVCTLPPSRDELTKNQVSLSCAVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
  • Component
    Glycosylation sites (N)
    Sequence
    524 $ 299''''
  • Component
    Glycosylation sites (N)
    Sequence
    524 $ 299''
  • Component
    Disulfide bridges
    Sequence
    22-96 $ 22''-96'' $ 22'''-98''' $ 23'-93' $ 23''''-93'''' $ 139'-199' $ 139''''-199'''' $ 146-202 $ 146''-202'' $ 152'''-212''' $ 222-219' $ 222''-219'''' $ 263''-323'' $ 369''-427'' $ 371-427 $ 447-232'''' $ 453-228'' $ 456-231'' $ 488-548 $ 581-351'' $ 594-652
  • Component
    Light chain: 1'''-232''' anti-CD3E
    Type
    Protein
    Sequence
    EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMNWVRQAPGKGLEWVSRIRSKYNNYATYYADSVKGRFTISRDDSKNTLYLQMNSLRAEDTAVYYCVRHGNFGNSYVSWFAYWGQGTLVTVSSASVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
  • Component
    Light chain: 1'-219' plus 1''''-219'''' anti-MS4A1
    Type
    Protein
    Sequence
    DIVMTQTPLSLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLVSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCAQNLELPYTFGGGTKVEIKRTVAAPSVFIFPPSDRKLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

  • 50242-125
  • 50242-127

Related records

Trials (91)

Approved for (2)

In development for (7)

Targets (4)