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 …

• Oral plenary session presentation on dara­tu­mu­mab Phase III Castor study data
• Trial in progress poster presentation from Phase I study of sub­cu­tane­ous dara­tu­mu­mab

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that two dara­tu­mu­mab abstracts have been accepted for presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3 — 7. The titles of the abstracts are avail­able on the ASCO website at www.asco.org via ASCO's iPlanner. With the exception of the dara­tu­mu­mab Phase III Castor study data, which has been designated as a late breaking abstract by ASCO, the full abstracts are scheduled to be …

Good morning, myeloma world.

It's just Tuesday, and already the week is getting in­ter­est­ing. We'll be reporting on just two myeloma-related news items today, but one of them is the kind of news we don't see here at Myeloma Morning very often.

In particular, the German bio­tech com­pany MorphoSys has sued Janssen Biotech and Genmab, the two com­pa­nies that have devel­oped and mar­keted Darzalex (dara­tu­mu­mab). MorphoSys contends that sales of Darzalex infringe on a MorphoSys patent.

In addi­tion, we report on a study that came out last …

Martinsried / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that it filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. This patent, which is owned by MorphoSys, describes and claims anti­bodies with particular features that bind to CD38.

By its complaint, MorphoSys seeks redress for the infringing manu­fac­ture, use and sale of Janssen's and Genmab's dara­tu­mu­mab, an anti­body targeting CD38. Janssen and Genmab recently obtained …

A belated good morning to you, myeloma world.

How has your Friday been so far? Has April Fools' Day brought joy, con­ster­na­tion, or a bit of both to your life?

We were caught off guard this morning by some news that came out just as we were about to wrap up this edition of Myeloma Morning. But the news, which con­cerns Darzalex, is good, so we definitely won't be com­plaining.

Here are today's myeloma-related headlines.

First, Darzalex (daratumuab) is a big step closer to being approved as a new myeloma treat­ment …

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 …