FDA unsure on Polivy's benefit-risk in frontline setting

9 March 2023

Staff at the US Food and Drug Administration (FDA) have prepared a report on the use of Roche’s (ROG: SIX) Polivy (polatuzumab vedotin) alongside Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated large B-cell lymphoma.

Polivy has already won accelerated US approval for diffuse large B-cell lymphoma, in combination with Rituxan and bendamustine, after at least two prior therapies.

It has also won a European approval for use in frontline patients based on the Phase III POLARIX study.

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