This year’s American Society of Clinical Oncology (ASCO) annual meeting began the morning of last Friday, and the meeting will run through Tues­day.

Multiple myeloma-related pre­sen­ta­tions are taking place every day of the meeting. Friday, how­ever, was the busiest day at the meeting in terms of oral pre­sen­ta­tions with new myeloma-related re­search. There were nine such pre­sen­ta­tions during a single afternoon session focused on multiple myeloma.

In addi­tion, there were myeloma-related education session pre­sen­ta­tions on Saturday, yesterday, and today. There also was a late-breaking ab­stract session yesterday (Sunday) with one pre­sen­ta­tion that …

Die Europäische Kommission hat Darzalex (Daratumumab) für die Behandlung des multiplen Myeloms zugelassen.

Die Zulassung bedeutet, dass Myelompatienten in Europa mit Darzalex behandelt werden können, ohne sich in eine klinische Studie einschreiben zu müssen.

Die europäische Darzalex-Zulassung ist für den Einsatz des Medikamentes als Einzelsubstanz, d.h. ohne andere anti-Myelom Medikamente, bei Erwachsenen mit rezidiviertem und refraktärem multiplen Myelom. Die Patienten müssen vorher mit einem Proteasomenhemmstoff und einer immunmodulatorischen Substanz behandelt worden sein und sie müssen nach ihrer letzten Therapie einen Krankheitsprogress haben.

Die Proteasomenhemmstoffe schließen Medikamente wie Velcade (Bortezomib), Kyprolis (Carfilzomib) und …

The European Com­mis­sion has approved Darzalex (dara­tu­mu­mab) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Darzalex without having to enroll in a clin­i­cal trial.

The European Darzalex approval is for use of the drug as a single agent – meaning Darzalex by itself, with no other anti-myeloma ther­apy – in adults with re­lapsed and refractory multiple myeloma. Patients must have been pre­vi­ously treated with a pro­te­a­some inhibitor and with an immun­o­modu­la­tory agent, and …

First-in-class CD38-directed active immuno­therapy provides new treat­ment option for MM patients who have exhausted other approved treat­ment options

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted con­di­tional approval to DARZALEX® (dara­tu­mu­mab) 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. Dara­tu­mu­mab was approved under an accelerated assess­ment, a process reserved for medicinal prod­ucts ex­pec­ted to be of major public health interest, particularly from the point of view of thera­peutic inno­va­tion.¹

Daratumumab is the first …

• 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 …

Good morning, myeloma world.

Since the last edition of Myeloma Morning, abstracts for two im­por­tant upcoming medical meetings have been made public: the American Society of Clinical Oncology (ASCO) annual meeting, which will take place June 3 through June 7 in Chicago, and the European Hematology Association (EHA) annual congress, which is scheduled for June 9 through June 12 in Copenhagen, Denmark.

The publication of the abstracts and the meetings themselves mean that there is going to be a lot of multiple myeloma-related news in the coming weeks. We will do our …

• 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% …