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Life Extending Lenalidomide is a Viable Treatment Option

(Pub. 19th July, 2012)

Lenalidomide is a life extending drug for patients suffering from myelodysplastic syndrome and multiple myeloma. For people with myelodysplastic syndrome, enduring this condition in which the bone marrow produces not only misshapen, but also not enough healthy blood cells, Lenalidomide is an essential treatment. Acting as a catalyst for the bone marrow to produce healthy blood cells, Lenalidomide also kills abnormal cells in the bone marrow. Cancer patients with multiple myeloma find Lenalidomide, when used alongside dexamethasone, is efficacious at controlling the progression of this bone marrow cancer. Known as the brand name Revlimid, the patent for Lenalidomide expires on October 4, 2019.

 Belonging to a new class of medications deemed immunomodulatory drugs, Lenalidomide is available as capsules in 5,10,15 and 25 milligram strength. Celgene holds the patent for Revlimid, and touts the drug as it's most important cancer drug, which is approved in both the U.S. and Europe. Sales of Revlimid (Lenalidomide) totaled $3.2 billion in 2011, which was roughly 66 percent of Celgene's total revenue for the year.

 Results from three major clinical trials investigating Lenalidomide/Revlimid maintenance therapy were published in The New England Journal of Medicine on May 11, 2012. Patients newly diagnosed with multiple myeloma participated in all of the trials, with patients in two of the three trials undergoing a stem cell transplant as well. As an extended treatment, known as maintenance therapy, patients were randomly assigned to take either Revlimid/Lenalidomide, or a placebo on a regular basis until they suffered a relapse. This is a typical protocol for maintenance therapy, with patients receiving an intensive initial course of therapy, followed by appropriate pharmacologic continued care. Extremely positive results were gleaned from all three trials, showing maintenance therapy with Lenalidomide significantly delayed the progression of multiple myeloma in participants. Furthermore, patients who were newly diagnosed, had a stem cell transplant and were younger experienced an even better result from Lenalidomide, gaining almost double the time before a relapse, in comparison to their older counterparts. These trials, which were Phase 3, were carried out in the United States and in Europe. Patients recruited for the first two studies were under age 70, and all had to be eligible for a transplant.

 The third trial study in Phase 3 was coined the MM-015 study, and was conducted in Europe, Australia, and Israel. Patients were required to be 65 years of age or older, as well as transplant ineligible. Trial participants were then placed in one of three groups. The first group, termed "MP" was comprised of 154 patients who received nine 4-week cycles of prednisone, melphalan and a placebo as initial therapy. Maintenance therapy was a placebo. Group two, known as "MPR" received nine 4-week cycles of melphalan, prednisone, and 10 milligrams on days 1-21 of Lenalidomide. All 153 patients in this group were given a placebo as maintenance therapy. The third group, comprised of 152 patients were denoted "MPR-R". These patients were dosed with prednisone, melphalan and 10 milligrams of Lenalidomide on days 1-21 of the study. However, the maintenance therapy for this group was 10 milligrams of Lenalidomide for 1-21 days out of every 28 day cycle. The third group, who were administered Lenalidomide as a maintenance dose, experienced a greater progression-free survival rate when compared to the patients who received the placebo as maintenance therapy. Patients in group three lived 26 months longer, whereas the first two groups had an average life extension of 7 months.

 While physicians are often hesitant to prescribe potent immunomodulatory drugs, such as Lenalidomide to patients, the benefits of even a few months of progression-free survival is crucial for people with incurable illnesses. The advent and possibilities of generic alternatives of Lenalidomide offers a beacon of hope for patients suffering from these life threatening maladies.

YES Pharma is proud to be a leading supply source for Lenalidomide (CAS# : 191732-72-6, 444796-87-6) to several global pharmaceutical companies and academic research institutes, while recognizing that we play a significant part in promoting the struggle against Cancer. The Lenalidomide that YES Pharma supplies is intended for laboratory R&D use only.



The Street (online) 6/21/12
The New England Journal of Medicine 5/11/12
The Myeloma Beacon


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