FDA Committee Backs Roche's Lymphoma Treatment
March 10 2023 - 1:57AM
Dow Jones News
By Mauro Orru
A U.S. Food and Drug Administration committee voted in favor of
Roche Holding AG's Polivy antibody drug targeting untreated diffuse
large B-cell lymphoma, the most common form of non-Hodgkin lymphoma
in the U.S.
The Swiss pharmaceutical company said Friday that the oncologic
drugs advisory committee had voted 11 to two in favor of Polivy in
combination with Rituxan plus cyclophosphamide, doxorubicin and
prednisone to treat the disease, though the move isn't binding. The
committee provides the FDA with independent opinions and
recommendations, and an agency decision is expected by April 2.
"Today's committee decision to recognize the potential of this
Polivy combination as a first-line treatment option is important
since four in ten people with diffuse large B-cell lymphoma relapse
or do not respond to initial treatment," said Levi Garraway,
Roche's chief medical officer and head of global product
development.
Roche presented data from a Phase 3 study late last year,
showing that its Polivy drugs mix can significantly reduce the risk
of disease deterioration or death for people with untreated diffuse
large B-cell lymphoma. Most patients with the untreated disease who
received the Polivy drugs mix reported clinically meaningful
improvements in lymphoma symptoms after the first cycle of
treatment, Roche said in December.
The Polivy drugs mix has been approved in more than 60
countries, including the U.K., Japan, Canada, China and the
European Union.
Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94
(END) Dow Jones Newswires
March 10, 2023 01:42 ET (06:42 GMT)
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