European Commission has approved Gazyvaro, a glycoengineered monoclonal antibody, for treating chronic lymphocytic leukemia, Roche said in a statement Tuesday.
Roche expects to start introducing Gazyvaro in a number of European countries this year.
Gazyvaro was approved after a late-stage study showed use of the drug in combination with chemotherapy extended the life of patients without a worsening of the disease, Roche said.
The CLL form of leukemia accounts for about 30% of all incidents of the disease, which kills roughly 13,000 people every year in Europe.
Gazyvaro’s approval could help Roche retain sales for leukemia treatments when an older drug, Rituxan/MabThera, loses patent protection.
Roche, which owns California-based Genentech Inc., has moved aggressively to replace drugs that are on the verge of losing patent protection, such as Rituxan/MabThera. During its earnings last week, the company touted the performance of two breast-cancer treatments that were developed to replace Herceptin, its third-biggest selling drug.
Agencies/Canadajournal
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