Roche's Genentech Gets FDA Priority Approval For Polivy Regimen
June 10 2019 - 12:58PM
Dow Jones News
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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