Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 130 |
| INN | Polatuzumab vedotin |
| Status | Approved |
| Drug code(s) | RG7596, DCDS4501A |
| Brand name | POLIVY |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-Citrulline, mc-val-cit PABC, Cleavable linker |
| Ave. DAR | 3 to 4 drugs per mAb |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | CD79b |
| Indications of clinical studies | Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma or Diffuse Large B-Cell Lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 07, 2011 |
| Start of Phase 2 | September 15, 2012 |
| Start of Phase 3 | November 15, 2017 |
| Date BLA/NDA submitted to FDA | December 19, 2018 |
| Year of first approval (global) | 2019 |
| Date of first US approval | June 10, 2019 |
| INN, US product name | Polatuzumab vedotin, polatuzumab vedotin-piiq |
| US or EU approved indications | Approved in US, in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies |
| Company | Hoffmann-La Roche |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in EU January 16, 2020. Feb 19, 2019: Roche today announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 19 August 2019.Polatuzumab vedotin granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with relapsed or refractory DLBCL; US and EU orphan drug designations for diffuse large B-cell lymphoma. NCT03274492 Phase 3 in Diffuse Large B-Cell Lymphoma recruiting as of Nov 15, 2017. NCT01691898 Phase 2 study active but not recruiting as of Aug 2017 |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
DAR: ave 3-4; mc-val-cit PABC linker
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |