Basic Information
Polivy
Regulatory Information
EMEA/H/C/004870
January 16, 2020
November 14, 2019
6
March 21, 2025
Company Information
Germany
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
Roche Registration GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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).
Overview Summary
Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL, a blood cancer affecting white blood cells): - in patients whose cancer has not been treated before. It is used in combination with rituximab, cyclophosphamide and doxorubicin (other cancer medicines) and prednisone (a corticosteroid); - in patients whose cancer has returned or has stopped responding to other treatments and who cannot have a stem cell transplantation (a procedure where the patient’s bone marrow is replaced by stem cells from a donor to form new bone marrow), Polivy is used in combination with two other cancer medicines, bendamustine and rituximab. DLBCL is rare, and Polivy was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 April 2018. Further information on the orphan designation can be found here: [ema.europa.eu/medicines/human/orphan-designations/eu3182013](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182013). Polivy contains the active substance polatuzumab vedotin.