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Roche: FDA Grants Polivy Accelerated Approval - Quick Facts

Swiss drug major Roche (RHHBY) announced Tuesday that the US Food and Drug Administration or FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) or BR. The approval is for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma or DLBCL, who have received at least two prior therapies.

The approval for this indication was based on complete response rates observed in a randomised, controlled phase Ib/II GO29365 clinical trial.

The company noted that the new targeted medicine was shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen.

The US FDA granted Priority Review for the company's Biologics License Application for Polivy in February 2019.

Further, Roche announced that Peter Voser will step down as a member of the Board at the end of June.

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