Polatuzumab vedotin
As of the edition of 20 October 2026, Polatuzumab vedotin is an antibody drug conjugate: marketed, first approved in 2019 (US); acts on CD79B, TUBB and TUBB1 and 7 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody drug conjugate
- Brand name
- Polivy
- First approved
- 10 June 2019 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 80, 7 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Chemically induced; Heart and blood vessels; Infections
US protection
US protection ends in 2031.
US protection ends in 2031, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Roche. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Polatuzumab vedotin.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| TUBB4A | Tubulin beta-4A chain | P04350 |
| TUBB | Tubulin beta chain | P07437 |
| CD79B | B-cell antigen receptor complex-associated protein beta chain | P40259 |
| TUBB4B | Tubulin beta-4B chain | P68371 |
| TUBB3 | Tubulin beta-3 chain | Q13509 |
| TUBB2A | Tubulin beta-2A chain | Q13885 |
| TUBB8 | Tubulin beta-8 chain | Q3ZCM7 |
| TUBB6 | Tubulin beta-6 chain | Q9BUF5 |
| TUBB2B | Tubulin beta-2B chain | Q9BVA1 |
| TUBB1 | Tubulin beta-1 chain | Q9H4B7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 10 | 2 | 7 | 1 |
| Phase 2 | 61 | 9 | 43 | 5 |
| Phase 3 | 7 | 3 | 3 | 1 |
| All trials | 80 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Originator, Applicant and Lead sponsor of trials | 2011 to now |