Polatuzumab vedotin

Polatuzumab vedotin (Polivy, Roche Registration GmbH) has 2 EU-approved indications in 1 tumour type.
Approved indications of Polatuzumab vedotin
Biomarker requirementRegimenSettingConditions
Large B-cell lymphoma2
None
+ rituximab, cyclophosphamide, doxorubicin, and prednisone
1L
DLBCL only
None
+ bendamustine and rituximab
2L
DLBCL only; Not candidates for haematopoietic stem cell transplant
Full text of section 4.1 (therapeutic indications)

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). 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.

Label history

9 changes to the Polivy label since 2020, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes