• DARZALEX (dara­tu­mu­mab) receives European con­di­tional mar­ket­ing authori­za­tion for heavily pre-treated or double refractory multiple myeloma
• First CD38 mono­clonal anti­body approved in Europe

Copenhagen, Denmark; May 23, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted a con­di­tional mar­ket­ing authori­za­tion for first-in-class CD38 anti­body DARZALEX® (dara­tu­mu­mab). The con­di­tional approval is for the use of DARZALEX® as mono­therapy for the treat­ment of adult patients with re­lapsed and refractory multiple myeloma, whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy. The EC approval follows a pos­i­tive opinion issued …

• Phase III POLLUX study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point at a pre-planned interim analysis
• Independent Data Monitoring Committee rec­om­mends unblinding the data
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III POLLUX study (MMY3003) of dara­tu­mu­mab in combi­na­tion with lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p < 0.0001). Patients who received treat­ment with dara­tumu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone had a 63% …

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 …

Pivotal TOURMALINE-MM1 Results Demonstrated that the Addition of Oral Ixazomib to Lena­lido­mide and Dexamethasone Significantly Extended Progression-Free Survival, with Limited Additional Toxicity in Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that results from the inter­na­tional, ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clin­i­cal study, eval­u­ating once-weekly oral NINLARO® (ixazomib) capsules plus lena­lido­mide and dexa­meth­a­sone versus placebo plus lena­lido­mide-dexamethasone in patients with re­lapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Admin­istra­tion (FDA), based on the pivotal TOURMALINE-MM1 data, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of …

Good morning, myeloma world.

After a busy week here at Myeloma Morning Headquarters, we're pleased to report that things are a bit more relaxed today. We're not sure if it's the weekend, or the cooler, overcast weather outside. Whatever the reason, we're enjoying the somewhat slower pace.

That pace is reflected in what we'll be covering in today's edition of Myeloma Morning. We'll be discussing just three new myeloma research articles.

The first article is a discussion of how to treat relapsed multiple myeloma, co-authored by Dr. Pieter Sonneveld, a leading myeloma …

First-in-class mono­clonal anti­body targeting CD38 for the treat­ment of multiple myeloma

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion rec­om­mending a con­di­tional mar­ket­ing authori­sa­tion for first-in-class CD38 immuno­therapy DARZALEX® (dara­tu­mu­mab) in the European Union. The rec­om­mended indi­ca­tion is for mono­therapy of adult patients with re­lapsed and refractory multiple myeloma (MM), whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy.¹ This appli­ca­tion was reviewed under an accelerated …

PharmaMar intends to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year

Madrid (Press Release) – PharmaMar (MSE:PHM) today announced positive top-line results of its Phase III clin­i­cal trial -ADMYRE- with Aplidin® (plitidepsin) in combination with dexa­metha­sone versus dexa­metha­sone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin® has shown a statistically sig­nif­i­cant 35% reduction in the risk of pro­gres­sion or death over the com­parator (p=0.0054). The study has met its pri­mary end­point.

This pivotal, ran­dom­ized, open-label, inter­na­tional, multi­center Phase III clin­i­cal trial, called ADMYRE, en­rolled 255 patients in 83 medical …