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Roche’s Polivy Wins Support From FDA Adcom For Treating B-Cell Cancer
Roche has announced that the US FDA Oncologic Drugs Advisory Committee voted 11 to 2 in favor of a Polivy (polatuzumab vedotin-piiq) combination therapy for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). In the treatment, Polivy is combined with Rituxan (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP).
The FDA is expected to make the final call for the supplemental Biologics License Application (sBLA) for Polivy in this indication by April 2, 2023. Polivy has been previously approved to treat adults with DLBCL that has progressed or returned after two or more prior therapies.
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Polivy Reduced Disease Progression Risks by 27%
Polivy is an antibody-drug conjugate (ADC) that targets the CD79b protein specific to most B-cells, the immune cells that go cancerous in some types of non-Hodgkin lymphoma (NHL) like DLBCL. Upon binding to cancer cells, Polivy delivers its anti-cancer component to destroy the cells while minimizing damage to normal cells.
The sBLA submission is based on data from the Phase 3 Polarix study. In the pivotal study, Polivy plus R-CHP showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care R-CHOP in first-line DLBCL. The risk of disease progression, relapse, or death was reduced by 27% in the Polivy plus R-CHP compared to R-CHOP.
Safety results for Polivy were consistent with those of previous trials. The safety of the combination treatment was also comparable to that of R-CHOP, with the rates of Grade 3-4 adverse events being 57.7% versus 57.5%, serious AEs at 34.0% versus 30.6%, Grade 5 AEs at(3.0% versus 2.3%, and AEs leading to dose reduction at 9.2% versus 13.0%.
“Today’s committee decision to recognise the potential of this Polivy combination as a first-line treatment option is important since four in ten people with diffuse large B-cell lymphoma relapse or do not respond to initial treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
“We believe the clinical benefit demonstrated in the Polarix study may improve outcomes for many people with newly diagnosed DLBCL and look forward to continued collaboration with the FDA to make this treatment option available in the US.”
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