The combination therapy is intended to treat previously untreated diffuse large B-cell lymphoma (DLBCL), which is the most common form of non-Hodgkin lymphoma (NHL).
It is claimed to be the first treatment regimen to significantly improve outcomes for DLBCL in over 20 years.
An anti-CD79b antibody-drug conjugate (ADC), Polivy works by binding to cancer cells like CD79b and kills the B-cells delivering an anti-cancer agent.
The drug, which is being developed using Seagen ADC technology, is now being examined to treat several NHL types.
The European Commission is expected to provide its final decision for Polivy plus R-CHP therapy soon.
Roche chief medical officer and Global Product Development head Levi Garraway said: “A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to existing therapies.
“Therefore, more treatment options are needed that could increase a person’s chance of cure, and we look forward to bringing this new Polivy combination to people with DLBCL as soon as possible.”
The regulator’s positive opinion was based on the data obtained from the Phase III POLARIX study (GO39942).
In this study, the Polivy plus R-CHP was compared to the standard of care MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to treat first-line DLBCL.
After a median follow-up of 28.2 months, the Polivy combination treatment showed significantly higher progression-free survival (PFS) compared to R-CHOP along with decreased disease worsening risk.