EMA Panel Endorses Polatuzumab for Diffuse Large B-Cell Lymphoma

Nick Mulcahy

November 15, 2019

The drug review panel of the European Medicines Agency (EMA) has recommended marketing approval of polatuzumab vedotin (Polivy, Genentech/Roche) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab (BR).

This week, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of the drug, which is for patients who are not candidates for hematopoietic stem cell transplant.

The drug is already approved in the United States.

Polatuzumab is a first-in-class antibody-drug conjugate. The new drug binds to a specific protein (CD79b) found only on B cells, then releases chemotherapy into those cells.

DLBCL is a common type of non-Hodgkin lymphoma and is curable. However, about 30% to 40% of patients relapse. 

Polatuzumab in combination with BR yields higher rates of complete responses compared with BR alone.

In the phase 1b/2 GO29365 study among 80 patients with relapsed or refractory DLBCL randomly assigned to receive polatuzumab with BR (n = 40) or BR alone (n = 40), the complete response rate at the end of treatment, which was the primary endpoint, was 40% with polatuzumab plus BR compared with 18% with BR alone.

Of the 25 patients treated with polatuzumab plus BR who achieved a complete or partial response, 16 (64%) had a duration of response lasting at least 6 months as compared with 3 (30%) of the 10 people treated with BR alone. Additionally, 12 (48%) of the 25 patients treated with polatuzumab plus BR had a duration of response lasting at least 1 year as compared with 2 (20%) of 10 people treated with BR alone.

Enrolled patients had received a median of two prior therapies.

The most common side effects of the drug, said the EMA, are infections, neutropenia, thrombocytopenia, anemia, leukopenia, lymphopenia, neuropathy, dizziness, cough, gastrointestinal disorders, fatigue, pyrexia, asthenia, chills, and infusion-related reactions.

Polatuzumab will be available as a 140 mg powder for concentrate for solution for infusion.

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