Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the com­pany has entered into a master clin­i­cal trial col­lab­o­ration and supply agree­ment with Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc., to eval­u­ate the efficacy and safety of the first-in-class CD38-directed immuno­ther­apy dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with a pro­te­a­some inhibitor (PI) car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and car­filz­o­mib for the treat­ment of patients with cancer. Janssen licensed dara­tu­mu­mab from Genmab A/S and is responsible for all global devel­op­ment, mar­ket­ing and manu­fac­tur­ing.¹ …

Initial Phase 3 Registrational Study Planned in Relapsed or Refractory Multiple Myeloma Patients

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced a col­lab­o­ration with Janssen Biotech, Inc. to eval­u­ate the com­bi­na­tion of Amgen's KYPROLIS® (car­filz­o­mib) and Janssen's DARZALEX® (dara­tu­mu­mab) in multiple clin­i­cal studies in patients with multiple myeloma. Under the terms of the agree­ment, the com­pa­nies may elect to supply drug only or supply drug and share devel­op­ment costs on a study-by-study basis.

The first study ini­ti­ated as part of this agree­ment is a Phase 3 registrational trial eval­u­ating KYPROLIS in com­bi­na­tion with DARZALEX and dexa­meth­a­sone com­pared to KYPROLIS and dexa­meth­a­sone …

• New Phase III study combining dara­tu­mu­mab, car­filz­o­mib and dexa­metha­sone in re­lapsed / refractory multiple myeloma – dosing ex­pec­ted in 2017
• First study under Clinical Trial Collaboration and Supply Agreement be­tween Janssen and Amgen
• Agreement covers all poten­tial oppor­tu­ni­ties combining dara­tu­mu­mab and car­filz­o­mib to treat cancer

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab (DARZALEX®) will be in­ves­ti­gated in a Phase III clin­i­cal study in com­bi­na­tion with car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone in patients with re­lapsed/refractory multiple myeloma. The study will be conducted under a master clin­i­cal trial col­lab­o­ration and supply agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and …

This year, the autumn colors have been unusually magnificent here in Colorado. I believe this Indian summer has been the finest show in recent years.

The riot of colors on the hillsides created a contrast to what was hap­pen­ing to my body. Multiple myeloma cells were ad­vanc­ing aggres­sively and reducing the pro­duc­tion of nor­mal blood cells. I became acutely ill with severe anemia, easy bleeding, and shortness of breath.

My husband Mark and I had planned a three-week trip to the East Coast for the end of September to revisit the life …

• U.S. FDA grants Priority Review to dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone for re­lapsed multiple myeloma — February 17, 2017 PDUFA date
• U.S. FDA grants Standard Review to dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for re­lapsed or refractory multiple myeloma — June 17, 2017 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in combi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. The sBLA was submitted by Genmab's licensing partner, Janssen Biotech, Inc. in August 2016. Priority Review …

Phase 3 data sup­porting sub­mission suggests poten­tial clin­i­cal benefit of dara­tu­mu­mab as a back­bone ther­apy in com­bi­na­tion with either a pro­te­a­some inhibitor (PI) or an immuno­modu­la­tory agent for re­lapsed multiple myeloma patients

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), seeking to broaden the existing mar­ket­ing authori­sa­tion for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab) to in­clude treat­ment of adult patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The expanded indi­ca­tion is based on dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone, or bor­tez­o­mib (a PI) and dexa­meth­a­sone.

Daratumumab is cur­rently approved by the European Com­mis­sion (EC) for mono­therapy of adult patients with …

• Application to broaden label for dara­tu­mu­mab for re­lapsed multiple myeloma submitted to EMA by Janssen
• Submission based on data from two Phase III studies, CASTOR and POLLUX
• Genmab to receive USD 10 million in mile­stone pay­ments from Janssen

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a variation to the Marketing Authori­za­tion to the European Medicines Agency (EMA) seeking to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. The sub­mission of the appli­ca­tion triggers mile­stone pay­ments totaling USD 10 million to Genmab from Janssen. The mile­stone pay­ments were in­cluded in …