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Outline
What is the generic name?
POLATUZUMAB VEDOTIN
What is the Trade Name for POLATUZUMAB VEDOTIN?
POLIVY
What are the Indications for POLATUZUMAB VEDOTIN?
- 1 INDICATIONS AND USAGE POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Accelerated approval was granted for this indication based on complete response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. POLIVY is a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. ( 1 ) Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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References: https://open.fda.gov/
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