10 June 2019 - Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product, to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. 

Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.

Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Polivy’s clinical benefit.

The FDA granted this application breakthrough therapy and priority review designations. Polivy also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Polivy to Genentech.

Read FDA press release