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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
ROG,
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
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