Roche's Genentech Gets FDA Priority Approval For Polivy Regimen

Date : 06/10/2019 @ 4:58PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 37.53  0.19 (0.51%) @ 9:38PM

Roche's Genentech Gets FDA Priority Approval For Polivy Regimen

Roche Holding (QX) (USOTC:RHHBY)
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By Colin Kellaher

 

The U.S. Food and Drug Administration on Monday said it granted accelerated approval to Roche Holdings AG's (ROG.EB) Genentech unit for Polivy as part of the first chemoimmunotherapy regimen for patients with the most common type of non-Hodgkin lymphoma.

The agency said the approval covers Polivy in combination with the chemotherapy bendamustine and a rituximab product in adults with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.

Roche markets the cancer drug rituximab under the name Rituxan. The FDA earlier this year granted priority review to the Polivy combination, with a target action date of Aug. 19.

The FDA's accelerated approval process enables the agency to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. The FDA said further clinical trials are required to verify and describe Polivy's clinical benefit.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 10, 2019 12:43 ET (16:43 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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