Daratumumab Receives Break­through Therapy Desig­na­tion For Multiple Myeloma – The U.S. Food and Drug Admin­istra­tion (FDA) last week granted breakthrough ther­apy desig­na­tion to the inves­ti­ga­tional drug daratumumab. The breakthrough ther­apy desig­na­tion is a new desig­na­tion, signed into law in 2012.  It is designed to accelerate the devel­op­ment and review process for drugs in­tended to treat serious or life-threatening illnesses. Dara­tu­mu­mab is being devel­oped by the Danish bio­technology com­pany Genmab together with Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) sub­sid­i­ary. It is a mono­clonal anti­body, like elotuzumab and siltuximab, that signals the immune sys­tem to kill myeloma cells. Results from a Phase 1/2 clin­i­cal trial indicated that dara­tu­mu­mab is effec­tive in heavily pre­treated myeloma patients (see related Beacon news). For more in­for­ma­tion, please see the Genmab press release.

Statins May Aid Stem Cell Collection In Multiple Myeloma – Results from a recent retro­spec­tive­ study indicate that statins may have a pos­i­tive impact on stem cell collection in multiple myeloma patients. Specifically, the researchers found that the success rate for sufficient stem cell collection was higher in patients who received statins during stem cell collection (85 per­cent), com­pared to patients who did not receive statins (64 per­cent). All patients received granulocyte colony-stimulating factor (G-CSF) as a stem cell mobilizing agent. The researchers point out that larger studies are nec­es­sary to con­firm their findings. Statins are drugs that lower cholesterol levels by inhibiting cholesterol pro­duc­tion in the liver. Atorvastatin (Lipitor) is the most common statin admin­istered to patients with heart disease. A pre­vi­ous study showed that statins reduce a myeloma patient’s chance of devel­op­ing the com­pli­ca­tion graft-versus-host disease after undergoing a donor stem cell trans­plant (see related Beacon news). For more in­for­ma­tion, please refer to the study in the journal Clinical Translational Oncology (abstract).

Study Finds Bisphosphonates May Not Decrease Kidney Function In Myeloma Patients Undergoing Stem Cell Transplantation – Findings from a retro­spec­tive­ study show that the bis­phos­pho­nates Boniva (ibandronate), Aredia (pamidronate), and Zometa (zoledronic acid) may not sig­nif­i­cantly de­crease kidney function in multiple myeloma patients undergoing stem cell trans­plan­ta­tion. The researchers also found that the impact of each of the three bis­phos­pho­nates on kidney function were similar.  Specifically, 33 per­cent of patients who received Boniva, 44 per­cent who received Aredia, and 21 per­cent who received Zometa ex­peri­enced a de­crease in creatinine clearance of at least 25 per­cent over the course of bis­phos­pho­nate ther­apy.  The researchers conclude that bis­phos­pho­nate ther­apy for up to three years appears to be safe on kidneys. Bisphosphonates are prescribed in multiple myeloma to slow down and prevent bone destruction. Previous studies have found that bis­phos­pho­nates may cause kidney damage. For more in­for­ma­tion, please see the study in the International Journal of Hematology (abstract).