EMA Recommends EU Approval of Roche’s Polivy Combination for Diffuse Large B-Cell Lymphoma

EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.

Roche announced on March 25, 2022 that the European Medicine Agency’s (EMA’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). The European Commission (EC) will make a final decision regarding the approval in the near future.

The new Polivy combination’s marketing authorization in the European Union for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for a hematopoietic stem cell transplant will be converted to a full approval once the EC makes a positive final decision.

According to a press release, an estimated 40,000 people in Europe are diagnosed with DLBCL each year, making it the most common form of non-Hodgkin lymphoma. Approximately 40% of people with previously untreated DLBCL are not cured with the current standard of care and face a poor prognosis.

“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,” said Levi Garraway, Roche’s chief marketing officer and head of global product development, in a press release. “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.”

Source: Roche