Roche: FDA priority review for polatuzumab vedotin

(CercleFinance.com) - Roche announces that the US FDA has accepted an application for a biological product license and has granted a priority review for polatuzumab vedotin, in combination with bendamustine plus Rituxan, in previously treated aggressive lymphoma.


This acceptance is based on a study that showed that this combination improves overall median survival, compared with bendamustine plus Rituxan alone. The FDA will make its decision on the approval by 19 August.

For the record, priority review is for drugs that the FDA considers to have the potential to significantly improve the safety or effectiveness of the treatment, prevention or diagnosis of a serious disease.



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