FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, in combination with the chemotherapy bendamustine and rituximab product, to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
FDA granted the approval of Polivy to Genentech. It granted the application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation.
Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (CD79b) found only on B cells, then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone.
Efficacy was based on complete response rate and duration of response, defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.