CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

The recommendation is based on pivotal data from the phase-III Polarix study

Roche recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in this disease in more than 20 years. A final decision regarding the approval of this Polivy combination is expected from the European Commission in the near future, Roche said in a statement.

“A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to the 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,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche, in the statement.

The CHMP opinion was based on efficacy and safety data from the phase-III Polarix study (GO39942), comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in treatment of first-line DLBCL. The study showed significantly higher progression-free survival (PFS) versus R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; P<0.02), according to the statement.

PFS is a clinically meaningful disease-related outcome for people with previously untreated DLBCL and represents a goal of first-line therapy: decreasing the risk of disease worsening. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34% versus 30.6%), grade 5 AEs (3% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13%), respectively. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting and Exposition and simultaneously published in the New England Journal of Medicine, added the statement.

Once approved, Polivy’s conditional marketing authorisation in the EU in combination with bendamustine plus MabThera, for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for a haematopoietic stem cell transplant will be converted to a full approval, the statement concluded.

B-cell lymphoma treatmentCHMPEU approvalNew England Journal of MedicinePolarix studyPolivyRoche
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