On June 10, 2019, the U.S. Food and Drug Administration (FDA) announced it has approved the use of polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least two prior therapies.
Approval was based on Study GO29365 (NCT02257567), an open-label, multicenter clinical trial that included a cohort of 80 patients with relapsed or refractory DLBCL after at least one prior regimen. Patients were randomized to receive either polatuzumab vedotin-piiq in combination with bendamustine and rituximab or bendamustine and rituximab for six 21-day cycles.
The FDA granted this application priority review, breakthrough therapy, and orphan drug designations. A description of the FDA expedited programs can be found here.
“The approval of polatuzumab vedotin-piiq in combination with bendamustine and rituximab offers patients with relapsed or refractory diffuse large B-cell lymphoma a new treatment option and new hope for improving patient outcomes,” said Meghan Gutierrez, CEO at the Lymphoma Research Foundation. “New medicines can transform the way healthcare providers approach this type of blood cancer and we commend those who contribute to accelerating research for the benefit of patients.”
For more information on this FDA approval visit the FDA’s website.