Generic drugs online

Source: Wall Street Journal

Date: 21-May-2010

Author: JENNIFER CORBETT DOOREN And RON WINSLOW

New uses for two established cancer drugs significantly increased the time patients survived without their disease progressing, in studies that provide fresh evidence of how cancer is often becoming a chronic disease.

Researchers said Rituxan, co-marketed in the U.S. by Roche Holding AG's Genentech unit and Biogen Idec Inc., cut the risk of cancer returning in certain lymphoma patients by half when used as a maintenance treatment for two years. In the other report, Celgene Inc.'s Revlimid doubled the number of myeloma patients whose disease remained in remission three years after treatment began, compared with those on placebo.

In many cancers, drugs are stopped after a set round of treatments. In both of these cases, patients were given the drugs for prolonged periods after their disease was initially treated with other regimens. Both studies were stopped ahead of schedule because of the strength of the benefit found during scheduled interim checks of the data.

The Rituxan study involved 1,018 patients who had been diagnosed with stage III or IV follicular lymphoma-a common type of non-Hodgkin's lymphoma-and whose disease was no longer detected after a combination treatment of chemotherapy and Rituxan.

About half of the patients were assigned to continue treatment every other month with Rituxan for two years, while the other half didn't receive the treatment.

The study, led by Gilles Salles, a professor of medicine at the University of Lyon in France, showed that after a median follow-up of 25 months, disease progression occurred in 18% of the Rituxan group, compared with 34% of the control group, which translates into a 50% reduction in the risk of disease recurrence. The findings were released in advance of the American Society of Clinical Oncology's annual meeting in June.

"This study suggests lymphoma, like many human cancers, is a chronic disease and increasingly is likely to require chronic therapy to maintain remission," said George Sledge, ASCO's president-elect and an oncologist at Indiana University School of Medicine.

Patients receiving Rituxan had a higher rate of infections at 37%, compared with 22% in the group of patients who didn't receive Rituxan as maintenance therapy.

Rituxan is currently approved as a treatment for non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. The product had more than $5 billion in global sales last year, with about half of the sales coming from the U.S. In March, Roche and Biogen Idec filed an application with the U.S. Food and Drug Administration seeking expanded approval of Rituxan as reflected in the study's findings. A spokeswoman for Roche said the wholesale cost of two years of Rituxan treatment is about $47,000.

In the Revlimid study, 614 patients under age 65 who underwent a transplant of their own stem cells to initially treat myeloma were given either a placebo or 25 milligrams of the drug for 21 days in each of the next two months, followed by a lower daily dose of Revlimid.

Michel Attal, a professor of hematology at Purpan Hospital in Toulouse, France, who was a leader of the study, reported that three years after patients were randomized, 68% of those taking Revlimid remained in remission, compared with 35% on placebo.

Overall survival after two years was similar among both groups-88% on the drug versus 80% on placebo. Dr. Attal said he expected a longer follow-up to show that the drug prolonged survival as well. Revlimid, which is approved for multiple myeloma patients in combination with the steroid dexamethasone, and for a rare condition called myelodysplastic syndromes, had revenue of $1.7 billion in 2009.