The pharma­ceu­tical com­pa­nies Bristol-Myers Squibb and AbbVie an­nounced this morn­ing that the U.S. Food and Drug Admin­istra­tion has granted break­through ther­apy desig­na­tion to the inves­ti­ga­tional drug elo­tuz­u­mab.

Specifically, the Food and Drug Admin­istra­tion (FDA) granted break­through ther­a­py desig­na­tion to elotuzumab in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) for mul­ti­ple myeloma patients who have re­ceived one or more prior ther­a­pies.

The break­­through ther­apy desig­na­tion is a new desig­na­tion that was signed into law in 2012. It is de­signed to ac­cel­er­ate the de­vel­op­ment and review process for drugs in­tended …

Designation granted for inves­ti­ga­tional agent elotuzumab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies

Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted elotuzumab, an inves­ti­ga­tional humanized mono­clonal anti­body, Break­through Therapy Desig­na­tion for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies. The desig­na­tion is based on findings from a ran­dom­ized Phase 2, open-label study that eval­u­ated two dose levels of elotuzumab in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone in pre­vi­ously-treated …

• Median progression-free survival (PFS) of 33 months reached after longer-term follow up in patients treated with elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone
• Longer-term safety profile of the combination consistent with previously reported results
• Results Presented at 18th Annual Congress of the European Hematology Association
• Two Phase 3 studies of elotuzumab at 10 mg/kg dose ongoing in patients with previously-treated and newly-diagnosed multiple myeloma

Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and AbbVie (NYSE: ABBV) to­day an­nounced up­dated ef­fi­cacy and safety data from a small, ran­dom­ized Phase 2, open-label study in patients with pre­vi­ously-treated mul­ti­ple myeloma that eval­u­ated two doses of the inves­ti­ga­tional mono­clonal anti­body elotuzumab (10 mg/kg and 20 mg/kg) in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone. In the 10 mg/kg arm (N=36), which is the dose used in the on­go­ing Phase 3 trials, median pro­gres­sion-free sur­vival (PFS), or the time without dis­ease pro­gres­sion, …

This year’s meeting of the American Society of Clinical Oncology (ASCO) was held May 31 through June 4 in Chicago.

During the meeting, The Beacon pub­lished daily up­dates that provided over­views of the im­por­tant mul­ti­ple myeloma findings pre­sented during the meeting.

Now that the meeting has concluded, the focus shifts to the bigger picture: What were the key findings of the meeting? Were there re­­sults with im­medi­ate im­pli­ca­­tions for the treat­ment of mul­ti­ple myeloma?  Did the re­search at the meeting rep­re­sent a major step for­ward for myeloma patients, or …

This year’s American Society of Clinical Oncology (ASCO), which was held in Chicago, began on Friday and concluded on Tuesday.

Monday was the busiest day at the meeting with regard to myeloma re­search.  It featured a session of oral pre­sen­ta­tions in the morn­ing and a poster session in the afternoon.

This up­date summarizes the myeloma-related stud­ies pre­sented during the afternoon poster session, which was the final myeloma-related session of the meeting. An earlier article covered the findings from the oral pre­sen­ta­tions that were given in the morn­ing.

Most of the key …

In a recent review article pub­lished in the journal Clinical Cancer Re­search, two myeloma experts from the Dana-Farber Cancer In­sti­tute, Dr. Nikhil Munshi and Dr. Kenneth Anderson, review the latest strategies in the treat­ment of mul­ti­ple myeloma.

In their article, the experts discuss newer ther­a­pies that appear to be promising in clin­i­cal and pre­clin­i­cal stud­ies.

According to the physicians, com­bi­na­tion ther­a­pies that spe­cif­i­cally target a patient’s ge­netic form of the dis­ease will be re­quired for long-term dis­ease con­trol and ultimately a cure.

Some Historical Perspective

In their review article, Drs. Munshi and …

The American Society of Clinical Oncology will hold its 49^th annual meeting May 31 through June 4 in Chicago.

Similar to pre­vi­ous years, more than 25,000 clin­i­cal spe­cialists from all over the world are ex­pec­ted to attend the five-day meeting to discuss the cur­rent re­search in cancer treat­ment and care. The theme for this year’s meeting is “Building Bridges to Conquer Cancer.”

During the meeting, there will be pre­sen­ta­tions and seminars about all areas of cancer, in­clud­ing many focused spe­cif­i­cally on mul­ti­ple myeloma. The ASCO website cur­rently lists more than 60 myeloma-based pre­sen­ta­tions (included …