• 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 …

Janssen Biotech, the Johnson & Johnson sub­sid­i­ary that mar­kets the myeloma ther­apy Darzalex globally, has decided to halt two clin­i­cal trials testing the drug in com­bi­na­tion with other cancer treat­ments.

One of the Darzalex trials involves patients with pre­vi­ously treated metastatic non-small cell lung cancer, while the other trial involves patients with re­lapsed or refractory multiple myeloma.

Genmab, the Danish com­pany that initially devel­oped Darzalex (dara­tu­mu­mab) before licensing it to Janssen, announced news of the trial can­cel­la­tions this past Saturday.

Genmab reported that, in the lung cancer trial, no benefit was seen …

• Based on a recent planned review, the Data Monitoring Committee (DMC) rec­om­mends Phase Ib/II study of dara­tu­mu­mab plus atezo­lizu­mab (anti PD-L1 anti­body) in patients with pre­vi­ously treated non-small cell lung cancer to be terminated.
• Phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283 (anti PD-1 anti­body) in patients with multiple myeloma, dis­con­tinued
• Health Authorities have been informed about these events and Janssen has contacted its partner com­panies conducting dara­tu­mu­mab and anti-PD-(L)1 com­bi­na­tion studies to discuss ceasing enrollment and dosing of the com­bi­na­tion while the data is being further in­ves­ti­gated

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that fol­low­ing a planned review, the DMC has rec­om­mended that the Phase Ib/II study (CALLISTO/LUC2001) of dara­tu­mu­mab in com­bi­na­tion with atezo­lizu­mab versus atezo­lizu­mab mono­therapy in patients with previ­ously treated ad­vanced or metastatic non-small cell lung cancer should be terminated. In addi­tion the phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283, an anti PD-1 anti­body in patients with multiple myeloma will be dis­con­tinued.

The DMC de­ter­mined that there was no observed benefit within …

• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• First approval for DARZALEX in a frontline indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Appli­cation (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing part­ner, Janssen Biotech, Inc., in November 2017. The U.S. FDA sub­se­quently granted priority review to the …

The results of a small, single-arm study conducted at the Ohio State University indicate that adminis­tering Darzalex using a time-saving 90-minute in­fusion protocol can be safe.

No patients in the study ex­peri­enced severe in­fusion-related reac­tions, and there was only one mild reac­tion in a patient who had no further reac­tions during sub­se­quent in­fusions at the 90-minute rate.

The faster Darzalex (dara­tu­mu­mab) in­fusion rate tested in the study is two hours shorter than the standard 3.5 hour rate. Patients in the study were receiving their third, or sub­se­quent, Darzalex in­fusions.

Infusion-related …