• CHMP issued a pos­i­tive opinion for DARZALEX® in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III MAIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) 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 in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Type …

As I mentioned in my recent columns, my M-spike and serum free light chain levels have been rising over the past few months, in­di­cating I might have to start treat­ment in the near future. The reprieve from med­i­ca­tions this year had been really nice, but in the world of myeloma, it seems to be wishful thinking that my dis­ease would suddenly halt and disappear without help from the drugs avail­able to us now.

So, earlier this month, upon consultation with my doctors and my family, I decided to try a new …

A team of Dutch researchers has published results of a small study in­ves­ti­gat­ing the impact of Darzalex treat­ment on immuno­glob­u­lin levels in multiple myeloma patients.

In their study, the researchers focus in particular on how the levels of a patient’s un­in­volve­d immuno­glob­u­lins are affected by treat­ment with Darzalex.

Uninvolved immuno­glob­u­lins in myeloma patients are immuno­glob­u­lins that have a type dif­fer­en­t from any mono­clonal immuno­glob­u­lin made by a patient’s myeloma cells.

Someone with IgG multiple myeloma, for example, has myeloma plasma cells that produce mono­clonal immuno­glob­u­lin G (IgG). For this myeloma patient, the …

Silver Spring, MD (Approval & Safety Notification) – On Sep­tem­ber 26, 2019, the Food and Drug Admin­istra­tion approved dara­tu­mu­mab (DARZALEX, Janssen) for adult patients with multiple myeloma in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone in newly diag­nosed patients who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

Efficacy was in­ves­ti­gated in CASSIOPEIA (NCT02541383), an open-label, ran­dom­ized, active-controlled phase 3 study com­par­ing induction and con­sol­i­da­tion treat­ment with dara­tu­mu­mab 16 mg/kg in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (DVTd) to treat­ment with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) in patients with newly diag­nosed multiple myeloma eli­gible for …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, thalido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible 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. (Janssen) in March 2019. The U.S. FDA sub­se­quently granted priority review to the sBLA, …

• Phase III CANDOR study of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prove­ment in pro­gres­sion free sur­vival
• Data to be discussed with health author­i­ties in preparation for regu­la­tory sub­missions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day top­line re­­sults from the Phase III CANDOR study, sponsored by Amgen, of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (Kd) versus Kd alone in patients with mul­ti­ple myeloma who have re­lapsed after one to three prior ther­a­pies. The study met the pri­mary end­point of im­prov­ing pro­gres­sion free sur­vival (PFS). The regi­men re­­sulted in a 37% re­duc­tion in the risk of pro­gres­sion or death in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma treated with …

First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma

Thousand Oaks, CA (Press Release) -- Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study eval­u­ating KYPROLIS® (car­filz­o­mib) in com­bi­na­tion with dexa­meth­a­sone and DARZALEX® (dara­tu­mu­mab) (KdD) com­pared to KYPROLIS and dexa­meth­a­sone alone (Kd) met its pri­mary end­point of pro­gres­sion-free survival (PFS). The regi­men resulted in a 37% reduction in the risk of pro­gres­sion or death in patients with re­lapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated …