Polivy (polatuzumab vedotin)
- Region
- 🇪🇺 EU
- Active substance
- polatuzumab vedotin
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Lymphoma, B-Cell
- CHMP opinion
- Thu 14 Nov 2019
- EU approval
- Thu 16 Jan 2020
- Designations
- Orphan, PRIME
- Application
- EMEA/H/C/004870
- ATC
- L01FX14
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.