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Pharmaceuticals / Submissions and Approvals

Genentech Wins Accelerated Approval for Chemoimmunotherapy

June 17, 2019
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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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