• 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 …

• 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 …

Toronto (Press Release) - Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma. Health Canada will review the sub­mission with ad­vance con­sid­er­a­tion under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) mono­therapy study.

Daratumumab is a new class of ther­apy – a human anti-CD38 mono­clonal anti­body. It received Break­through Therapy Desig­na­tion and the Biologics License Application (BLA) was granted priority review and accelerated approval by …

First-in-class immuno­therapy approved for multiple myeloma patients who have received three or more prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent or who are double refractory to a PI and immuno­modu­la­tory agent

Horsham, PA (Press Release) – Janssen Biotech, Inc., a Janssen Pharma­ceu­tical Company of Johnson & Johnson, announced today the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX^® (dara­tu­mu­mab) injection for in­tra­venous in­fusion for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­latory agent, or who are double-refractory to a PI and an immuno­modu­la­tory agent.¹ This indi­ca­tion is approved under accelerated approval based on response rate. Continued approval for this indi­ca­tion may be contingent upon veri­fi­ca­tion …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA for heavily pre-treated or double refractory multiple myeloma
• First mono­clonal anti­body approved for multiple myeloma
• Financial guidance updated to in­clude USD 45 million mile­stone pay­ment

Copenhagen, Denmark (Press Release) – Genmab A/S (OMX: GEN) announced today the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX™ (dara­tu­mu­mab) injection for in­tra­venous in­fusion for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are double-refractory to a PI and IMiD.¹ This indi­ca­tion is approved under accelerated approval based on response rate. Continued approval for this indi­ca­tion may be …