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% …

Liebe Myelomwelt, Ihnen allen einen schönen Samstag.

Wir haben heute über einige gute Nachrichten zu berichten. Es handelt sich dabei auch um wichtige Nachrichten über Darzalex (Daratumumab).

Anfang der Woche wurden einige neue Studienergebnisse veröffentlicht, denen jedoch nicht viel Aufmerksamkeit geschenkt wurde.

Diese neuen Ergebnisse zeigen, dass die Zugabe von Darzalex zu Velcade (Bortezomib) und Dexamethason das progressionsfreie Überleben bei rezidivierten Myelompatienten wesentlich - einige sagen, sogar drastisch – verlängert. Die neuen Ergebnisse gehen über die Nachrichten, die bereits Ende März bekannt gegeben wurden und über die wir in einer vorherigen Ausgabe …

A happy Saturday to you, myeloma world.

We have some good news to report today. It also is im­por­tant news related to Darzalex (dara­tu­mu­mab).

Some addi­tional clin­i­cal trial results related to Darzalex were made public earlier this week, but they have not received much attention.

The new results show that adding Darzalex to Velcade (bor­tez­o­mib) and dexa­metha­sone sub­stan­tially – some might even say dramatically – extends pro­gres­sion-free survival in re­lapsed multiple myeloma patients.

The new results expand on news announced at the end of March, which we covered in …