Roche Holding AG’s newly approved medicine Gazyva helped patients with chronic lymphocytic leukemia live almost a year longer without their disease progressing than its top-seller, Rituxan, in a clinical trial.
Patients taking Gazyva along with the chemotherapy chlorambucil lived for a median 26.7 months without their cancer spreading, compared with 15.2 months for those on Rituxan plus chlorambucil, Basel, Switzerland-based Roche said today. The data, from the last of three stages of testing necessary for U.S. approval, will be presented next month at the American Society of Hematology meeting in New Orleans.
Gazyva was approved Nov. 1 as the first medicine with the U.S. Food and Drug Administration’s new breakthrough therapy designation. CLL is a disease of the blood and bone marrow that typically worsens slowly. About 15,680 Americans will be diagnosed with the disease and about 4,580 will die from it this year, according to the National Cancer Institute.
“Given how much benefit Rituxan has provided to patients, it was a high bar to imagine that you could actually improve upon that,” Nancy Valente, head of Roche’s hematology development, said by phone.
Rituxan generated 6.71 billion Swiss francs ($7.16 billion) in 2012 for Roche, the world’s largest maker of cancer medicines, according to data compiled by Bloomberg. The drug also is approved for other diseases including non-Hodgkin’s lymphoma and rheumatoid arthritis. Analysts expect Gazyva to bring in 1.34 billion Swiss francs, on average, in 2018.
The 663-patient study turned up more side effects among those taking Gazyva than for those on Rituxan. Twenty percent of patients on Gazyva had an infusion-related reaction, compared with 4 percent on Rituxan. A third of patients in the Gazyva arm experienced neutropenia, or a low white blood-cell count, versus 27 percent for Rituxan. Infections occurred in 7 percent of patients in both arms.