Multiple Myeloma Oral Therapy REVLIMID Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved REVLIMID® (lenalidomide) as a treatment for multiple myeloma, a type of blood cancer. The oral treatment regimen, which includes a combination of REVLIMID plus the steroid drug dexamethasone, is indicated for relapsed patients who have failed one or more lines of therapy with other chemotherapy agents. Of all the centers participating in the Phase III clinical trial demonstrating significant patient benefit and leading to the approval, NewYork-Presbyterian Hospital/Weill Cornell Medical Center’s Multiple Myeloma Center had the greatest number of enrolled patients in the United States.

Approval was given after the results of clinical trials in which patients who took REVLIMID and dexamethasone survived an average of nearly 30 months. In contrast, patients on dexamethasone and placebo survived a little over 20 months. Multiple myeloma is incurable and one of the most deadly of all cancers with a typical life expectancy of four years following diagnosis. Results were presented at an oral session during the 42nd American Society of Clinical Oncology (ASCO) meeting in Atlanta in June 2006.

“REVLIMID has been shown to be tremendously effective, and we are thrilled that now it will be more widely available,” says Dr. Ruben Niesvizky, director of NewYork-Presbyterian/Weill Cornell’s Multiple Myeloma Program and associate professor of clinical medicine at Weill Medical College of Cornell University.

The Multiple Myeloma Program at NewYork-Presbyterian/Weill Cornell, one of the three largest such centers in the U.S., takes an aggressive and multidisciplinary approach—offering programs for transplants, vaccine development and drugs, as well as clinical research trials for all stages of the disease. The Myeloma Program is also investigating other investigational drug therapies. Along with Dr. Niesvizky, Drs. Roger Pearse, Morton Coleman and Michael Schuster conduct research and treat patients at the Multiple Myeloma Program.

The Center of Excellence for Lymphoma and Myeloma at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is currently the only medical center in the nation to offer a research protocol using a chemotherapy cocktail with REVLIMID, known as BiRD, an acronym for its component parts: Biaxin® (clarithromycin, an antibiotic), REVLIMID, and dexamethasone (Decadron®, a steroid). This single-center Phase II clinical trial for patients with newly diagnosed multiple myeloma is anticipated to show whether improved complete remission rate, response time, and decreased toxicity can be obtained with BiRD, when compared to the standard treatment. It is an induction therapy, the first step toward shrinking the cancer and evaluating patient response to the potential treatment.

Multiple myeloma is a cancer that causes white blood cells to become malignant and attack the body’s bones, resulting in painful fractures, kidney failure and death. The second most prevalent blood cancer after non-Hodgkin’s lymphoma, multiple myeloma affects an estimated 50,000 Americans, with 14,000 new cases diagnosed every year. From 1973 to 1999, the U.S. has seen a 35 percent increase in multiple-myeloma deaths; these numbers are rising for reasons that are not understood.

Weill Cornell Medical College has been paid by Celgene of Summit, N.J., makers of REVLIMID, to conduct these and other REVLIMID studies with Dr. Ruben Niesvizky as the principal investigator. Dr. Niesvizky occasionally serves as a paid consultant to Celgene.