The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2020-01-16

Latest approval

2020-01-16

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2020-01-16Approval

Approval: Polivy (EMA)

Indication: 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… Show full indication

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).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

66 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 66

Phase 19Phase 1 / 218Phase 233Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Active, not recruitingPH IIIKey trialHoffmann-La Rochen=1,1302030

A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Active, not recruitingPH IIIHoffmann-La Rochen=2082027

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

CompletedPH IIIKey trialHoffmann-La Rochen=1,0002026

Open-label, Prospective Phase III Clinical Study to Compare Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) With Rituximab, Ifosfamide, Carboplatin and Etoposide (R-ICE) Alone as Salvage Therapy in Patients With Primary Refractory or Relapsed Diffuse Large B-cell Lymphoma (DLBCL)

CompletedPH IIIGWT-TUD GmbHn=3062025

A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

CompletedPH IIIHoffmann-La Rochen=2702024

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIIKey trialHoffmann-La Rochen=1,0002026

CompletedPH IIIGWT-TUD GmbHn=3062025

A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients With Diffuse Large B-Cell Lymphoma Following First-Line Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

CompletedPH I/IIHoffmann-La Rochen=1882025

A Pilot Study of Subcutaneous Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for Untreated Indolent B-Cell Non-Hodgkin Lymphoma

CompletedPH IIUniversity of Washingtonn=422025

A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

CompletedPH IHoffmann-La Rochen=1112024

CompletedPH IIIHoffmann-La Rochen=2702024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.

The New England journal of medicine · 2022 · 677 cites

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cyclophosphamide

Studied across the same disease area as Polatuzumab vedotin in the shared literature.

1 shared disease1 shared paper

Doxorubicin

Studied across the same disease area as Polatuzumab vedotin in the shared literature.

1 shared disease1 shared paper

Prednisone

Studied across the same disease area as Polatuzumab vedotin in the shared literature.

1 shared disease1 shared paper

Vincristine

Studied across the same disease area as Polatuzumab vedotin in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.