The FDA has granted accelerated approval to polatuzumab vedotin-piiq (Polivy, Genentech), combined with bendamustine and a rituximab product (a combination known as BR), to treat adults with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after prior therapy.
Annually, more than 18,000 people in the United States are diagnosed with DLBCL, a quick-growing cancer that can spread from the lymph nodes to the bone marrow, spleen, liver, or other organs. Although it is curable, approximately 30–40% of patients relapse. Signs and symptoms include swollen lymph nodes, fever, recurring night sweats, and weight loss.
Polatuzumab vedotin-piiq is an antibody that is attached to a chemotherapy drug. After binding to CD79b, a specific protein found only on B cells, it releases the chemotherapy drug into those cells.
The new therapy was evaluated in a study of 80 patients with relapsed/refractory DLBCL who were randomized to receive either polatuzumab vedotin-piiq + BR or BR alone. Efficacy was based on the complete response rate and duration of response (DOR), defined as the time the disease stays in remission.
At the end of treatment, the complete response rate was 40% with polatuzumab vedotin-piiq + BR compared to 18% with BR alone. Of the patients who achieved a partial or complete response to the combination, 16 had a DOR of at least six months and 12 had a DOR of at least 12 months.
The most common side effects in patients treated with polatuzumab vedotin-piiq + BR include neutropenia, thrombocytopenia, and anemia; peripheral neuropathy; fatigue; diarrhea; fever; decreased appetite; and pneumonia.
Patients should be monitored for infusion-related reactions, low blood counts, fatal and/or serious infections, tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy (PML), a fatal or life-threatening brain infection.
Women of reproductive age should use effective contraception while taking polatuzumab vedotin-piiq and for three months after their last dose. The drug is not recommended for pregnant or breastfeeding women as it may cause harm to the developing fetus or newborn.
The FDA granted breakthrough therapy, orphan drug, and priority review designations to this application.
Source: FDA, June 10, 2019