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. …

Findings from a retrospective study show that there have been significant changes in the treatment of newly diagnosed multiple myeloma patients in the United States since 1999.

In particular, more patients are being treated soon after diagnosis. In recent years, the use of novel agents, such as thalidomide (Thalomid), Velcade (bor­tezomib), and Revlimid (lenalidomide), and stem cell transplantation have be­come more common. At the same time, the use of conventional chemo­ther­a­py, such as melphalan (Alkeran),

Stem Cell Mobilization With Cyclophosphamide And G-CSF Is More Effective And Less Expensive Than Mozobil And G-CSF – Findings from a recent study show that cyclo­phos­phamide (Cytoxan) plus granulocyte colony-stimulating factor (G-CSF) is more ef­fec­tive than Mozobil (plerixafor) plus G-CSF as a stem cell mobilization ther­apy for mul­ti­ple myeloma patients. Both Mozobil and cyclo­phos­phamide in­crease the number of stem cells that can be harvested during collection. Patients in the recent study who re­ceived the cyclo­phos­pha­mide-G-CSF com­bi­na­tion collected sig­nif­i­cantly more …

Further findings from two clinical studies of Revlimid maintenance thera­py were presented at the 14^th International Myeloma Workshop (IMW) in Kyoto, Japan, earlier this month.

Both studies involved newly diagnosed multiple myeloma patients who received maintenance therapy with Revlimid (lenalidomide).

Results from both studies, which were published in the New England Journal of Medicine last May, indicate that Revlimid maintenance therapy significantly increases progression-free survival compared to a placebo (see related Beacon news). One of the studies also …

Velcade-Thalidomide-Dexamethasone Combination May Be Effective After A Stem Cell Transplant In Multiple Myeloma Patients – Results from a French study show that the combination of Velcade (bortezomib), thalidomide (Thalo­mid), and dexamethasone (Decadron), commonly referred to as VTD, may improve response rates in multiple myeloma patients after stem cell trans­planta­tion. The complete response rate for patients who received VTD as a consolidation therapy (52 percent) was significantly higher than the rate for patients who re­ceived a placebo (30 …

FDA Puts Dara­tu­mu­mab On Fast Track For Treatment Of Multiple Myeloma – The U.S. Food and Drug Admin­istra­tion (FDA) last week granted fast track desig­na­tion to the inves­ti­ga­tional drug daratumumab. The fast track desig­na­tion ac­cel­er­ates 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 …

Findings from a small, retrospective French study show that an autolo­gous stem cell transplant followed by a reduced-intensity donor stem cell transplant may lead to long-term control of multiple myeloma.

With a median follow-up time of seven years, the five-year progression-free and overall survival rates were 26 percent and 52 percent, re­spec­tively.

The results of the current study also show that myeloma patients who receive a donor transplant as part of their first-line of treatment appear to benefit more from …