Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­sa­tion to in­clude 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.

“This sub­mission to health author­i­ties takes us one step closer to our goal of redefining com­bi­na­tion ther­apy in multiple myeloma, with the poten­tial to make dara­tu­mu­mab …

• Application to broaden label for dara­tu­mu­mab in front line multiple myeloma sub­mitted to EMA
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 3 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 Type II variation appli­ca­tion to the European Medicines Agency (EMA). This appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use 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). The sub­mission of the appli­ca­tion triggers mile­stone …

DARZALEX com­bi­na­tion ther­apy offers a new option for patients pre­vi­ously treated with two commonly used treat­ments (lena­lido­mide and a pro­te­a­some inhibitor)

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the immuno­therapy DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing lena­lido­mide (an immuno­modu­la­tory agent) and a pro­te­a­some inhibitor (PI).¹ Clinical trial results showed an over­all response rate (ORR) of 59.2 per­cent with DARZALEX in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone in these patients.¹

DARZALEX is the first CD38-directed anti­body approved any­where in the world.² It was …

First-in-class CD38-directed mono­clonal anti­body now approved for use in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted approval to DARZALEX®▼ (dara­tu­mu­mab) for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib (VELCADE®) and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at least one prior ther­apy.

The EC’s de­ci­sion was based on data from the Phase 3 POLLUX (MMY3003) study, presented in the plenary session at ASCO 2016 and published in the New England Journal of Medicine, in August 2016¹; and Phase 3 CASTOR (MMY3004) study, presented …

DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) com­pared to standard of care regi­mens alone

Toronto, ON (Press Release) – Janssen Inc. announced today that Health Canada has approved DARZALEX® (dara­tu­mu­mab), 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.¹ Due to the high unmet medical need for multiple myeloma patients, DARZALEX® was granted a Priority Review by Health Canada for this sub­mission.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^2,3 The dis­ease can be very complex to treat as …

Janssen’s first-in-class CD38-directed mono­clonal anti­body now rec­om­mended for approval earlier in the treat­ment path­way in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today 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).¹ If approved by the European Com­mis­sion, dara­tu­mu­mab can be used in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone; or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that it has added a second patent with US Patent Number 9,200,061 to its lawsuit against Janssen Biotech, and Genmab, A/S. This patent claims methods of treating hema­to­logic cancer asso­ci­ated with the undesired presence of CD38-positive cells by admin­istering anti­bodies that bind to a specific region of the target molecule, CD38. In a hearing that took place on Feb­ru­ary 6, 2017 the District Court granted MorphoSys's request to add the 9,200,061 patent to the …