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Pharmaceuticals / Submissions and Approvals

Genentech Wins Accelerated Approval for Chemoimmunotherapy

June 17, 2019

Genentech won accelerated approval from the FDA for the first chemoimmunotherapy treatment for the most common form of non-Hodgkin lymphoma.

Polivy (polatuzamab vedotin-piiq) is a novel antibody-drug conjugate now approved in combination with the chemotherapy bendamustine and rituximab for patients whose diffuse large B-cell lymphoma (DLBCL) has returned or progressed after at least two previous treatments.  DLBCL is the most common form of non-Hodgkin lymphoma.

The agency previously granted Polivy breakthrough therapy, priority review and orphan drug status.

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