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 ^[1]. 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 ^[2] and siltuximab ^[3], 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 ^[4] news). For more in­for­ma­tion, please see the Genmab ^[5] press re­lease.

Mayo Clinic Re­searchers Update Guidelines For Treatment Of Newly Diagnosed Myeloma – Re­searchers from the Mayo Clinic have up­dated their guidelines for the treat­ment of newly diag­nosed mul­ti­ple myeloma patients. The guidelines, called The Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART), were first devel­oped in 2007 and last up­dated in 2009. Based on re­search findings re­leased since 2009, the re­searchers have added six major up­dates to the pre­vi­ous version of mSMART. One sig­nif­i­cant up­date was the addi­tion of an intermediate-risk classification to the existing high-risk and standard-risk classifications. The re­searchers also note that there may be more ben­e­fit to delaying stem cell trans­plants in myeloma patients, due to im­proved induction ther­a­pies and stem cell collection pro­ce­dures. The up­dated guidelines also rec­om­mend that main­te­nance ther­apy be con­sidered, but not mandated, as a treat­ment op­tion for patients who have undergone a stem cell trans­plant. For more in­for­ma­tion, please see the 2013 mSMART Guidelines ^[6].

Sensory Deficits Prior To Treatment May Predict Risk Of Peripheral Neuropathy In Myeloma Patients – Results from a recent study in­di­cate that preexisting sensory deficits in mul­ti­ple myeloma patients in­crease a patient’s risk of devel­op­ing periph­eral neu­rop­athy (pain, tingling, and loss of sensation in the extremities due to nerve damage) fol­low­ing treat­ment for myeloma. Specifically, the re­searchers found that patients with sensory deficits before the start of treat­ment were at a higher risk of devel­op­ing treat­ment-induced periph­eral neu­rop­athy. Treatment-induced periph­eral neu­rop­athy is a common com­pli­ca­tion for myeloma patients who undergo treat­ment with Velcade ^[7] (bor­tez­o­mib) or thalidomide ^[8] (Thalomid). The re­searchers be­lieve that testing of nerve function prior to treat­ment may be able to identify patients at high risk of devel­op­ing treat­ment-induced periph­eral neu­rop­athy. For more in­for­ma­tion, please refer to the study in Cancer Chemotherapy and Pharmacology ^[9] (abstract).

Phase 1/2 Clinical Trial Of Elotuzumab Plus Revlimid, Velcade, And Dexa­meth­a­sone In Newly Diagnosed High-Risk Myeloma Patients Has Launched – The Southwest Oncology Group, in col­lab­o­ration with the National Cancer In­sti­tute and pharma­ceu­tical com­pany Bristol-Myers Squibb, has started a Phase 1/2 clin­i­cal trial of elotuzumab in com­bi­na­tion with Velcade, Revlimid ^[10] (lena­lido­mide), and dexamethasone ^[11] (Decadron). The study is open to newly diag­nosed high-risk myeloma patients. Elotuzumab, which is being devel­oped by Bristol-Myers Squibb (NYSE: BMY), is a mono­clonal anti­body that stim­u­lates the im­mune sys­tem to destroy myeloma cells. Previous stud­ies have shown that it is ef­fec­tive in re­lapsed and re­frac­tory myeloma patients, par­tic­u­larly when used in com­bi­na­tion with Revlimid and dexa­meth­a­sone (see re­lated Beacon ^[12] news). About half the patients in the new trial will be treated with Velcade, Revlimid, and dexa­metha­sone alone.  The other half will re­ceive the same three drugs plus elotuzumab.  For more in­for­ma­tion about the study, in­clud­ing how to en­roll, please see the clinical trial description ^[13].