Celgene Seeks Expanded Approval For Revlimid In Europe – The pharma­ceu­tical com­pany Celgene announced on Tuesday that it is seeking expanded approval for Revlimid ^[1] (lena­lido­mide) as treatment for multiple myeloma in Europe. The European Medicines Agency (EMA) will review approval of Revlimid for main­te­nance ther­apy of newly diag­nosed myeloma patients who have not progressed after initial ther­apy with melphalan ^[2] (Alkeran), prednisone ^[3], and Revlimid or after au­tol­o­gous stem cell trans­plan­ta­tion. Currently, Revlimid is approved in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients who have received at least one prior ther­apy. For more in­for­ma­tion, please see the Celgene ^[4] press release.

ENMD-2076 Is Safe In Relapsed/Refractory Multiple Myeloma (ASH 2010) – The inves­ti­ga­tional drug ENMD-2076, which is being devel­oped by the pharma­ceu­tical com­pany EntreMed, is safe in re­lapsed / refractory multiple myeloma patients, according to the interim Phase 1 trial results presented at the 2010 Meeting of the American Society of Hematology (ASH). Researchers tested four dif­fer­en­t dose levels (150 mg to 400 mg) in 28-day cycles. They observed pro­gres­sion of disease for all patients receiving the minimum dose of 150 mg. Patients receiving a dose of 300 mg achieved stable disease with reductions in serum M-protein. Researchers did not observe any dose-limiting side effects. Most side effects were mild to mod­er­ate and in­cluded nausea, diarrhea, and fatigue. The optimal dosage has not yet been de­ter­mined as the trial is still ongoing.  For more in­for­ma­tion, please see abstract 1957 ^[5] on the ASH annual meeting website and the clinical trial ^[6] description.

Daratumumab Emerges As Potential Treatment In CD38-Positive Multiple Myeloma – Preclinical results showed that the experimental drug dara­tu­mu­mab is highly effective at killing can­cer­ous cells that produce the CD38 molecule. The Danish bio­technology com­pany Genmab is cur­rently devel­op­ing dara­tu­mu­mab for treat­ment of CD38-positive multiple myeloma tumors. Researchers initially tested a broad array of CD38 anti­bodies against more than 10 pri­mary tumors from myeloma patients, and dara­tu­mu­mab was found to be the most effective at executing the immune sys­tem killing mech­a­nisms. Genmab is cur­rently conducting a Phase 1/2 study to de­ter­mine the safety and optimal dosage of dara­tu­mu­mab. For more in­for­ma­tion, please see the study in the Journal of Immunology ^[7] (abstract) and the clinical trial ^[8] description.

PBOX-15 Induces Cell Death In Multiple Myeloma Cells – Preclinical results dem­onstrated that the experimental drug com­pound PBOX-15 (1,5-benzoxazepine-15), discovered by Irish clin­i­cal scientists, is a promising treat­ment for multiple myeloma. Researchers found that PBOX-15 induced cell death in four dif­fer­en­t lines of multiple myeloma cells. In two of the cell lines, PBOX-15 in­creased the number of death re­cep­tor genes to stimulate cell death. For more in­for­ma­tion, please see the study in the British Journal of Cancer ^[9] (abstract).