FDA accepts supplemental BLA for Roche's Polivy combo

Swiss pharma giant Roche (ROG: SIX) has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab).

The combination, plus cyclophosphamide, doxorubicin and prednisone (R-CHP), is for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). An FDA decision on whether to approve the regimen is expected to be made by April 2, 2023.

DLBCL is an aggressive blood cancer which is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those who require subsequent lines of therapy have poor outcomes, Roche stressed.