Polatuzumab vedotin
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Polatuzumab vedotin
- polivy
- Polivy
- acd 79b vcmmae
- acd 79bvcmmae
- ACD-79B-VCMMAE
- ACD-79BVCMMAE
- acd79b vcmmae
- ACD79B-VCMMAE
- anti cd79b adc
- anti cd79b antibody drug conjugate anti cd79b vc mmae
- anti cd79b monoclonal antibody conjugated to monomethyl auristatin e mmae
- Anti-cd79b adc
- ANTI-CD79B ANTIBODY-DRUG CONJUGATE, ANTI-CD79B-VC-MMAE
- ANTI-CD79B MONOCLONAL ANTIBODY CONJUGATED TO MONOMETHYL AURISTATIN E (MMAE)
- dcds 4501a
- DCDS-4501A
- dcds4501a
- DCDS4501A
- fcu 2711
- FCU-2711
- fcu2711
- FCU2711
- immunoglobulin g1 kappa auristatin e conjugate anti homo sapiens cd79b immunoglobulin associated cd79 beta humanized monoclonal antibody conjugated to auristatin e
- IMMUNOGLOBULIN G1-KAPPA AURISTATIN E CONJUGATE, ANTI-(HOMO SAPIENS CD79B (IMMUNOGLOBULIN-ASSOCIATED CD79 BETA)), HUMANIZED MONOCLONAL ANTIBODY CONJUGATED TO AURISTATIN E
- polatuzumab vedotin
- Polatuzumab vedotin
- Polatuzumab Vedotin
And 32 more, listed on the interactive page.
- ATC classification codes
- L01FX14
Sources for recorded values
- CAS registry numbers
- 1313206-42-6
- ChEMBL ID
- CHEMBL3301582
- FDA ingredient codes (UNII)
- KG6VO684Z6
- 2174090
- 2174091
- Applicant
- GENENTECH
- Approval date
- 10 Jun 2019
- Application number
- BLA761121
- Status
- Authorised
- Status date
- 16 Jan 2020
- Authorisation date
- 16 Jan 2020
- Approved indications
- Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
- Product number
- EMEA/H/C/004870
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- Yes
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, B-Cell
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 19 Apr 2030
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- polatuzumab vedotin
- Type
- Antibody
- Drug name stem
- -dotin; -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-cell antigen receptor complex-associated protein beta chain binding agent
- Action type
- BINDING_AGENT
- Target
- B-cell antigen receptor complex-associated protein beta chain
- Protein identifier
- P40259
- Action
- Binding
- Action type
- Binding
- Target
- CD79B
- Gene symbol
- CD79B
- Protein identifier
- P40259
- Primary target
- Yes
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Mechanism
- B-cell antigen receptor complex-associated protein beta chain binding agent
- Action type
- BINDING AGENT
- Target
- B-cell antigen receptor complex-associated protein beta chain
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Lymphoma
- Highest recorded phase
- 1
- 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
- 3
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000630
- Subject identifier
- D018442
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001938
- Subject identifier
- D016393
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004095
- Subject identifier
- D016393
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001469
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001938
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004095
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004952
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007243
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0009348
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0017596
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019088
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0044889
- Highest recorded phase
- 3
- Event
- agranulocytosis
- Reports
- 25
- Reporting signal score
- 23.5977
- Event
- alanine aminotransferase increased
- Reports
- 50
- Reporting signal score
- 28.5909
- Event
- anaemia
- Reports
- 183
- Reporting signal score
- 159.218
- Event
- arthralgia
- Reports
- 2
- Reporting signal score
- 39.2402
- Event
- aspartate aminotransferase increased
- Reports
- 62
- Reporting signal score
- 51.4533
- Event
- blood lactate dehydrogenase increased
- Reports
- 39
- Reporting signal score
- 62.4041
- Event
- coronavirus infection
- Reports
- 20
- Reporting signal score
- 48.3799
- Event
- covid-19
- Reports
- 89
- Reporting signal score
- 138.273
- Event
- cytokine release syndrome
- Reports
- 47
- Reporting signal score
- 112.643
- Event
- cytomegalovirus enterocolitis
- Reports
- 9
- Reporting signal score
- 29.2294
- Event
- cytomegalovirus infection
- Reports
- 37
- Reporting signal score
- 59.1162
- Event
- cytomegalovirus infection reactivation
- Reports
- 36
- Reporting signal score
- 124.018
- Event
- cytomegalovirus test positive
- Reports
- 13
- Reporting signal score
- 35.5032
- Event
- cytopenia
- Reports
- 47
- Reporting signal score
- 107.259
- Event
- diffuse large b-cell lymphoma
- Reports
- 67
- Reporting signal score
- 217.077
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 80
- Reporting signal score
- 361.153
- Event
- diffuse large b-cell lymphoma refractory
- Reports
- 41
- Reporting signal score
- 207.147
- Event
- disease progression
- Reports
- 189
- Reporting signal score
- 307.501
- Event
- disease recurrence
- Reports
- 25
- Reporting signal score
- 23.9676
- Event
- dizziness
- Reports
- 8
- Reporting signal score
- 37.7554
- Event
- drug hypersensitivity
- Reports
- 1
- Reporting signal score
- 35.3418
- Event
- drug interaction
- Reports
- 2
- Reporting signal score
- 24.5161
- Event
- febrile neutropenia
- Reports
- 149
- Reporting signal score
- 240.499
- Event
- gamma-glutamyltransferase increased
- Reports
- 33
- Reporting signal score
- 32.5596
- Event
- gastrointestinal perforation
- Reports
- 18
- Reporting signal score
- 41.4217
And 32 more, listed on the interactive page.
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And 11 more, listed on the interactive page.
- Dose
- 1.8 mg/kg
- Route
- Intravenous
- How often
- Every 21 days for 6 cycles
- Administer over 90 minutes for the first dose, then 30 minutes if tolerated
- Premedicate with an antihistamine and antipyretic at least 30 minutes prior if not already premedicated
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQLTQSPSSLSASVGDRVTITCKASQSVDYEGDSFLNWYQQKPGKAPKLLIYAASNLESGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSNEDPLTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGYTFSSYWIEWVRQAPGKGLEWIGEILPGGGDTNYNEIFKGRATFSADTSKNTAYLQMNSLRAEDTAVYYCTRRVPIRLDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 50242-103
- 50242-105
Related records
Trials (191)
- A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
- A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
- A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
- A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)
- A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
- A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
- A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1
- A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
- A Preference Study Comparing Kristalose® and Liquid Lactulose
- A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
- A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
- A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
- A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
- A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
- A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
- A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
- A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Approved for (4)
In development for (8)
- B-cell chronic lymphocytic leukemia Phase 1
- Follicular lymphoma Phase 2
- Lymphoma Phase 1
- MALT lymphoma Phase 2
- Mantle cell lymphoma Phase 2
- Marginal zone lymphoma Phase 2
- Neoplasm of mature B-cells Phase 2
- Non-Hodgkin lymphoma Phase 3
Targets (16)
- CD79B B-cell antigen receptor complex-associated protein beta chain binding agent
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor