The Euro­pean Com­mis­sion has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma.

The ap­prov­al means that myeloma patients in Europe will now be able to be treated with Empliciti without having to en­roll in a clin­i­cal trial.

Empliciti's Euro­pean ap­prov­al comes on the heals of its ap­prov­al late last No­vem­ber in the United States, the mar­ket in which the drug re­ceived its first ever regu­la­tory ap­prov­al. As in the United States, Empliciti has been approved in Europe for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­meth­a­sone.

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First and only immunostimulatory anti­body approved in the Euro­pean Union for mul­ti­ple myeloma

Accelerated assess­ment and ap­prov­al based on long-term data from ELOQUENT-2, which eval­u­ated Empliciti in com­bi­na­tion with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (Rd)

ELOQUENT-2 dem­onstrated the Empliciti com­bi­na­tion de­liv­ered a 53% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival vs. Rd alone at three years (23% vs. 15%)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) an­nounced to­day that the Euro­pean Com­mis­sion has approved Empliciti™ (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone in patients who have re­ceived at least one prior ther­apy. Empliciti is now the first and only immunostimulatory anti­body approved for mul­ti­ple myeloma in the Euro­pean Union (EU).

The ap­prov­al is based on data from the ran­dom­ized, open-label, Phase 3 ELOQUENT-2 study, which eval­u­ated Empliciti in …

A happy Tuesday to you, myeloma world.

We have some in­ter­est­ing re­search to share with you.

First, we have re­­sults of a Phase 2 study investi­gating Empliciti (elotuzu­mab) in com­bi­na­tion with Velcade (bor­tez­o­mib) and dexa­metha­sone (Decadron) in re­lapsed and re­frac­tory myeloma patients. The re­­sults show that Empliciti plus Velcade and dexa­metha­sone im­proves pro­gres­sion-free sur­vival com­pared to Velcade and dexa­metha­sone alone, without adding any sig­nif­i­cant side effects.

We also report on a study out of Italy that explores using Treanda (benda­mustine) in addi­tion to mel­phalan (Alkeran) as the high-dose chemo­therapy …

As I mentioned in my pre­vi­ous column, I started treat­ment with the newly approved myeloma drug Empliciti (elo­tuzu­mab) in Feb­ru­ary. I thought I would share more details about my ex­peri­ences with the drug so far.

Before I started treat­ment with Empliciti, I had enjoyed a drug holiday for the pre­vi­ous three months. I ap­pre­ci­ated the break from the side effects of drugs and nu­mer­ous trips to the cancer center.

Before the drug holiday, I was on Kyprolis (car­filz­o­mib), Revlimid (lena­lido­mide) and dexamethasone (Decadron) for …

What a year 2015 was for the myelomatologist!

The U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of three new myeloma drugs, all within the span of a few weeks to­wards the end of the year, had already gen­er­ated great ex­cite­ment in the com­munity.

Then, sev­er­al poten­tial prac­tice-changing pre­sen­ta­tions at the 2015 American Society of He­ma­tol­ogy (ASH) annual meeting put the proverbial icing on the cake to round out a landmark year for myeloma thera­peutics.

This edition of the myeloma quiz highlights some of the key takeaways from the ASH 2015 meeting.

Positive opinion based on re­duc­tion in the risk of dis­ease pro­gres­sion or death with Empliciti in com­bi­na­tion with standard of care regi­men for mul­ti­ple myeloma dem­onstrated in ELOQUENT-2 study

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) has adopted a pos­i­tive opinion rec­om­mending that Empliciti (elo­tuzu­mab), an inves­ti­ga­tional immunostimulatory anti­body, be granted ap­prov­al for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone in patients who have re­ceived at least one prior ther­apy. The appli­ca­tion now will be reviewed by the Euro­pean Com­mis­sion, which has the authority to approve med­i­cines for the Euro­pean …

• ELOQUENT-2 extended follow-up analysis of Empliciti in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone (Rd) dem­onstrated a 44% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival at three years; re­­sults con­sis­tent with pivotal two year analysis
• Empliciti com­bi­na­tion had a median delay of one year in time to next treat­ment com­pared to Rd alone
• Pre-specified interim analysis for over­all sur­vival found a pos­i­tive trend favoring the Empliciti com­bi­na­tion versus Rd alone (HR 0.77; p=0.0257)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day pre­sented extended follow-up data and a pre-specified interim over­all sur­vival (OS) analysis of Empliciti in com­bi­na­tion with Revlimid^® (lena­lido­mide) and dex­a­meth­a­sone (ERd) in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma from ELOQUENT-2. The follow-up data dem­onstrated that Empliciti in com­bi­na­tion with Rd had an im­prove­ment in pro­gres­sion-free sur­vival (PFS) with a hazard ratio (HR) of 0.73 (95% CI: 0.60, 0.89; p=0.0014) versus Rd alone. This re­­sult was con­sis­tent …