Celgene Corporation, the manufacturer of Revlimid ^[1] (lenalidomide), announced on Monday that the company plans to file for approval of Revlimid as a treatment for newly diagnosed multiple myeloma. Celgene intends to file for regulatory approval in the United States and Europe in the second half of this year.

“Our objective is to make sure that the patients who have a fatal disease, a currently incurable disease, can take medicines that turn this into a chronic treatable disease,” said Celgene’s President and CEO Sol Barer during the announcement. “That is the mission in our hematology-oncology franchise.”

Revlimid is currently only approved to treat multiple myeloma in combination with dexamethasone ^[2] (Decadron) for previously-treated myeloma patients. Despite the limited approval, Revlimid already has a 30 percent market share as an initial therapy for myeloma patients in the U.S. However, physicians in Europe rarely use Revlimid outside of its approved use.

Preliminary results from the clinical trial MM-015 offer strong support for extending Revlimid use to the treatment of newly diagnosed patients. The study tested the drug as both an induction and a maintenance therapy in elderly patients.

In the study, researchers compared the combination of melphalan ^[3] (Alkeran) and prednisone ^[4] followed by a placebo (MP-Pl) with the combination of melphalan, prednisone, and Revlimid followed by Revlimid maintenance (MPR-R). The researchers discovered that MPR-R decreased the risk of disease progression by 50 percent (see related Beacon news ^[5]).

“The Revlimid arm was so superior the trial was unblinded early,” stated Barer. “We are incorporating the data for this trial into a [Food and Drug Administration] filing in the second half of 2010 for newly diagnosed and continuous treatment.”

In a conversation with The Myeloma Beacon, Celgene spokesperson Greg Geissman could not provide a specific timeline for the application, approval, and implementation of Revlimid as a treatment for newly diagnosed myeloma. Nonetheless, the drug’s approval would give patients and physicians another option when deciding how to begin treatment.

Celgene is also evaluating the drug’s effectiveness in treating smoldering myeloma patients (see related Beacon news ^[6]) and patients who have undergone a stem cell transplant. Beyond multiple myeloma, Revlimid is already approved for a specific group of patients with myelodysplastic syndromes ^[7] (disorders of the bone marrow and blood). Celgene has also launched clinical studies evaluating the drug for other myelodysplastic syndromes patients as well as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia patients.

“Our objective is to make sure that Revlimid will become one of the most important hematology products,” said Barer.

The decision to apply for an extended approval in multiple myeloma was announced at JP Morgan’s 28th annual Healthcare Conference, an event that provides companies with the opportunity to present a summary of their activities to investors.

For more information, please see a related Dow Jones ^[8] article or listen to the Celgene ^[9] Web cast.