Anti-cancer Rituxan cuts lymphoma recurrence in half: study

May 21, 2010

Long-term treatment with anti-cancer medication Rituxan, produced by Swiss laboratory Roche, can cut the recurrence of follicular lymphoma in some patients by half, a new study said.

A slow-growing form of blood cancer that usually develops in the lymph nodes, follicular lymphoma is one of the most commonly occurring in a group of diseases known as non-Hodgkins lymphomas.

"These findings provide hope for the way we manage this disease," said lead author Gilles Salles of the University of Lyon.

"Maintenance therapy" using rituximab, the generic name for Rituxan, "is likely to become a new standard of care for these patients," he said in a telephone press conference Thursday held by the American Society of Clinical Oncology ahead of its annual meeting in Chicago in June.

The study found that two years worth of maintenance therapy with rituximab reduced the risk of recurrence of follicular lymphoma by 50 percent in those patients who responded positively to initial chemotherapy.

The goal of maintenance therapy is to prolong remission in cancer patients. Those with follicular lymphoma are usually at risk of relapse within three to six years of their initial treatment.

The clinical study involved just over 1,000 patients with stage III or IV follicular lymphoma who saw positive effects from rituximab-based combination chemotherapy.

A randomly selected group of 505 patients received an additional two years of rituximab, while the rest of the group had no maintenance therapy.

After a median follow-up time of 25 months, the disease reappeared in 18 percent of those receiving the maintenance therapy, compared with 35 percent of those in the control group.

The benefits of the treatment were observed across all groups of patients, regardless of age, prior treatment, or their stage of remission, the study said.

Rituxan, known as MabThera in Europe, is generally well-tolerated by patients. The most common side-effect is infections, which were seen in 37 percent of those on the drug, compared with 22 percent in the control group.

On the basis of the tests, Roche and biotech company Biogen are seeking approval from the US Food and Drug Administration for use of Rituxan in maintenance therapy.

The study's conclusions "add to the body of evidence supporting Rituxan in non-Hodgkin's lymphoma and emphasize the role Rituxan plays in helping people with this cancer that will most likely recur," said Greg Reyes, senior vice president, Oncology Research and Development at Biogen.

"We look forward to discussing these new data with the FDA and European regulatory authorities," he said in a joint statement issued by Biogen and Roche.

The drug is already authorized for use in the United States and Europe for treatment of cancer and obtained FDA approval in 1997 for use against lymphoma, rheumatoid arthritis and certain forms of leukemia.

Worldwide sales of the drug totaled some 5.6 billion dollars in 2009.

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