• DARZALEX approved in Europe in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone in patients with newly diag­nosed multiple myeloma
• Approval follows pos­i­tive opinion by European Committee for Medicinal Products for Human Use (CHMP) in July
• Genmab to receive mile­stone pay­ment of USD 13 million from Janssen upon first sale of DARZALEX in the newly approved indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX^® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in July 2018. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) …

• sBLA & Type II Variation submitted to U.S. FDA and the EMA re­spec­tive­ly, seeking approval of split dosing regi­men for DARZALEX
• Applications seek to update Prescribing Information and Summary of Product Characteristics
• Submissions sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regi­men for DARZALEX^® (dara­tu­mu­mab). The appli­ca­tions request to update the Prescribing Information and Summary of Product Characteristics in order to provide health care professionals the option of splitting …

Raritan, NJ and Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regi­men for DARZALEX^® (dara­tu­mu­mab). The appli­ca­tions seek to update the Prescribing Information and Summary of Product Characteristics to provide health care professionals with the option to split the first in­fusion of DARZALEX^® over two consecutive days. The sub­missions are sup­ported by …

Shanghai, China (Press Release) – On August 8, 2018 Beijing time I-Mab Bio­pharma ("I-Mab"), a Shanghai-based bio­tech com­pany focused on inno­va­tive biologics in on­col­ogy and auto­immune dis­ease, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX;NASDAQ: MOR) an­nounced to­day that I-Mab has Submitted an inves­ti­ga­tional new drug (IND) appli­ca­tion to China National Drug Admin­istra­tion (CNDA) for TJ202 / MOR202, a human mono­clonal anti­body directed against CD38 for the treat­ment of multiple myeloma.

Multiple myeloma is the sec­ond most common blood cancer world­wide. The patient number has gradually in­­creased in China in …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rec­om­mended broadening the existing mar­ket­ing authori­sa­tion for Darzalex® (dara­tu­mu­mab) for use as frontline (initial) ther­apy.¹ The recom­men­da­tion is for the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone, for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).¹

“Multiple myeloma be­comes harder to treat each time it returns, so …

• CHMP issued pos­i­tive opinion for DARZALEX for front line multiple myeloma
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell …

Janssen Biotech, die Tochtergesellschaft von Johnson & Johnson, die die Myelom-Therapie Darzalex weltweit vermarktet, hat beschlossen, zwei klinische Studien einzustellen, in denen das Medikament in Kombination mit anderen Krebsbehandlungen getestet wird.

Eine der Darzalex-Studien betrifft Patienten mit metastasierendem, nicht-klein­zelligem Lungenkrebs, während die andere Studie Patienten mit rezidivieren­dem oder refraktärem multiplem Myelom betrifft.

Genmab, das dänische Unternehmen, das Darzalex (Daratumumab) entwickelt hat, bevor es an Janssen lizenziert wurde, gab am vergangenen Samstag bekannt, dass die Studien eingestellt wurden.

Genmab berichtete, dass in der Lungenkrebsstudie kein Nutzen für die Kombination von Darzalex mit einem …