London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced that it has re­ceived Break­through Therapy Desig­na­tion from the U.S. Food and Drug Admin­istra­tion (FDA) for GSK2857916 mono­­therapy in patients with mul­ti­ple myeloma who have failed at least three prior lines of ther­apy, in­­clud­ing an anti-CD38 anti­body and are re­frac­tory to a pro­te­a­some in­hib­i­tor and an immuno­modulatory agent. In Octo­ber, the Euro­pean Medicines Agency (EMA) granted PRIME desig­na­tion to GSK2857916 for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma patients whose prior ther­apy in­cluded a pro­te­a­some in­hib­i­tor, an immuno­modulatory agent …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), an on­col­ogy-focused, clin­i­cal stage bio­technology com­pany (the "company"), to­day an­nounces its lead PDC com­­pound, CLR 131 has achieved a median over­all sur­vival of 22.5 months to date after a single dose in­fusion of 12.5mCi/m² in patients with mul­ti­ple myeloma. Patients in the first cohort of the com­pany's Phase 1 clin­i­cal trial had an average of 5.8 prior lines of treat­ment and there­fore were con­sidered to be heavily pre­treated.

It is im­por­tant to note that the trial remains on­go­ing, and the over­all sur­vival could con­tinue …

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 …

Approval Based on TOURMALINE-MM1 Study Results, Which Demonstrated Statistically Significant Six-Month Improvement in Progression-Free Survival

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Com­mis­sion has granted con­di­tional market­ing authori­za­tion for NINLARO^TM (ixazomib) capsules, indicated in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for adult patients with multiple myeloma who have received at least one prior ther­apy. The de­ci­sion to approve NINLARO as the first and only oral pro­te­a­some inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) for Human Use in September 2016.

“For myeloma patients living …