The United States Food and Drug Admin­istra­tion (FDA) has approved elotuzumab for the treat­ment of mul­ti­ple myeloma.

The drug will be sold under the brand name Empliciti, and it will be mar­keted by the U.S. pharma­ceu­tical com­pany Bristol-Myers Squibb. The com­pany said in a press re­lease issued this Monday that it will begin shipping Empliciti “within the next 48 hours.”

Empliciti’s ap­prov­al is for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) in mul­ti­ple myeloma patients who have re­ceived one to three prior ther­a­pies.

There …

• First and only immunostimulatory anti­body approved for mul­ti­ple myeloma
• Approval based on ELOQUENT-2, which estab­lish­ed the com­bi­na­tion of Empliciti with lena­lido­mide and dexa­metha­sone (Rd) de­liv­ered a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit vs. Rd alone, dem­onstrated over two years (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004])

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istration (FDA) has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (ERd) in patients who have re­ceived one to three prior ther­a­pies. The ap­prov­al of this first and only immuno­stimulatory anti­body for mul­ti­ple myeloma is based on data from the ran­dom­ized, open-label, Phase 3, ELOQUENT-2 study, which dem­onstrated that the …

Silver Spring, MD (Press Release) – On No­vem­ber 30, 2015, the U. S. Food and Drug Admin­istra­tion approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Com­pany) in com­bi­na­tion with lena­lido­mide and dexa­metha­sone for the treat­ment of patients with mul­ti­ple myeloma who have re­ceived one to three prior ther­a­pies.

Elotuzumab is a mono­clonal anti­body directed against Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). SLAMF7 is present on myeloma cells and is also present on natural killer cells.

The ap­prov­al was based on a multi­center, ran­dom­ized, open-label, con­trolled trial eval­u­ating pro­gres­sion-free sur­vival (PFS) and over­all re­sponse …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted ap­prov­al for Empliciti (elo­tuzu­mab) in com­bi­na­tion with two other ther­a­pies to treat people with mul­ti­ple myeloma who have re­ceived one to three prior medi­ca­tions.

Multiple myeloma is a form of blood cancer that oc­curs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone mar­row. These can­cer­ous cells multiply, pro­duce an ab­nor­mal pro­tein and push out other healthy blood cells from the bone mar­row. This dis­ease may re­­sult in a weakened im­mune sys­tem, and …

This ac­ceptance for review marks the first in the U.S. for a SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for priority review the Biologics License Appli­ca­tion (BLA) for Empliciti (elo­tuzu­mab), an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­nation ther­apy in patients who have re­ceived one or more prior ther­a­pies. Empliciti was pre­vi­ously granted Break­through Therapy Desig­na­tion, which ac­cord­ing to the FDA, is in­tended to expedite the devel­op­ment and review of drugs for serious or life-threatening con­di­tions. The Euro­pean Medicines …

Earlier this week, Bristol-Myers Squibb an­nounced that it had filed an appli­ca­tion to have elotuzumab approved in Europe as a new treat­ment for mul­ti­ple mye­lo­ma patients who have re­ceived one or more prior ther­a­pies (see re­lated Bristol-Myers press re­lease).

An im­por­tant part of elotuzumab’s Euro­pean ap­prov­al appli­ca­tion will be ef­fi­cacy and safety data from a Phase 3 clin­i­cal trial known as ELOQUENT-2. These re­sults drew sig­nif­i­cant attention when they were pre­sented at this summer’s Amer­i­can Society of Clinical Oncology (ASCO) and Euro­pean Hema­tology Associ­a­tion …

Results from two clin­i­cal trials (ELOQUENT-2 & CA204-009), each combining Empliciti with a dif­fer­en­t standard of care regi­men in­cluded in the sub­mission

Empliciti is poised to be the first-in-class SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the Euro­pean Medicines Agency (EMA) val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion (MAA) for Empliciti, an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy in adult patients who have re­ceived one or more prior ther­a­pies. The appli­ca­tion was granted ac­cel­er­ated assess­ment by the EMA’s Com­mit­tee for Medicinal Products for Human Use (CHMP).

“We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for …