-- Scott Roberts
FRIDAY, Nov. 1 (HealthDay News) -- Gazyva (obinutuzumab) has
been approved by the U.S. Food and Drug Administration in
combination with the anti-cancer drug chlorambucil for people with
previously untreated chronic lymphocytic leukemia (CLL).
CLL is a progressive cancer of the blood and bone marrow. Some
15,680 Americans are likely to be diagnosed and 4,580 are projected
to die from the disease this year, the U.S. National Cancer
Gazyva is designed to bolster the immune system's ability to
attack cancer cells, the FDA said in a news release. The agency
said it granted the drug so-called "breakthrough therapy" status,
since clinical evidence indicates it "may offer a substantial
improvement over available therapies."
Approval was based on clinical studies of 356 people. Those
receiving the Gazyva/chlorambucil combination had an average of 23
months of progression-free survival, compared with 11.1 months
among participants who received chlorambucil alone, the FDA
The most common side effects of Gazyva were anti-drug reactions,
a decrease in white blood cells, low blood platelets and/or red
blood cells, muscle pain and fever.
Gazyva's label contains a boxed warning that it could trigger a
"reactivation" of the Hepatitis B virus, and it may increase users'
risk of a rare neurological disorder called progressive multifocal
Gazyva is marketed by Genentech, based in San Francisco.
The National Cancer Institute has more about
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