The agency cleared Gazyva to fight chronic lymphocytic leukemia in combination with chemotherapy in patients who haven't previously been treated for the disease.
Gazyva works by killing cancer cells and encouraging the immune system to fight against them.
Chronic lymphocytic leukemia develops slowly over time and is usually diagnosed in the elderly. More than 15,600 Americans will be diagnosed and 4,580 of them will die from the disease this year, according to estimates from the
The injectable biotech drug is the first medicine approved under
Gazyva will be marketed by Roche's
A spokeswoman for
Common side effects seen in company studies included anemia, fever, muscle and bone pain and lower levels of white blood cells.
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