• Daratumumab receives Break­through Therapy Desig­na­tion in com­bi­na­tion with standard of care regi­mens for multiple myeloma patients who have received at least one prior line of ther­apy
• Potential for accelerated review
• Marks second Break­through Therapy Desig­na­tion for dara­tu­mu­mab

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Break­through Therapy Desig­na­tion for DARZALEX^® (dara­tu­mu­mab) injection 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. Break­through Therapy Desig­nation is a pro­gram in­tended to expedite the devel­op­ment and review of drugs to treat serious or life-threatening diseases in cases where pre­lim­i­nary clin­i­cal …

A new ther­apy providing an im­por­tant option for multiple myeloma patients who have received three or more prior lines of ther­apy

Toronto, Canada (Press Release) – Janssen Inc. announced today Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX™ (dara­tu­mu­mab) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are refractory to both a PI and an IMiD. Health Canada approved this prod­uct on the con­di­tion that Janssen Inc. carries out con­firmatory trials to verify the clin­i­cal benefit of DARZALEX™.¹

Multiple myeloma is an incurable blood cancer that …

Basel, Switzerland (Press Release) – Mundipharma EDO GmbH (Early Development in Oncology) has announced the initiation of a first-in-human clin­i­cal trial of its inves­ti­ga­tional drug can­di­date EDO-S101. A first in class, fusion molecule - S101 is cur­rently being developed for the treat­ment of re­lapsed-refractory (RR) haematological malig­nan­ces. This phase 1 study is designed to eval­u­ate the safety and tolerability of ascending doses of EDO-S101 and will be conducted at several sites across the United States and Europe.

EDO-S101 is the first rep­re­sentative of the A-DAC principle, a new ap­proach in chemo­ther­apy that uses …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending against the authori­za­tion of NINLARO® (ixazomib) capsules, an oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma. Takeda intends to appeal this opinion and request a re-examination by the CHMP.

“We are disappointed by the CHMP’s opinion. With the sup­port of European key medical experts, we will con­tinue our efforts work­ing …

Pivotal Head-to-Head ENDEAVOR Study Shows Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) and Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indi­ca­tion for Kyprolis® (car­filz­o­mib) to in­clude treat­ment in com­bi­na­tion with dexa­meth­a­sone alone for adult patients with multiple myeloma who have received at least one prior ther­apy.

"In the first ever comparative Phase 3 head-to-head study of two pro­te­a­some inhibitors in re­lapsed multiple myeloma, Kyprolis in com­bi­na­tion with dexa­meth­a­sone nearly doubled pro­gres­sion-free survival compared to a current …

 Focusing on Repurposing Therapies in the Field of Oncology

Edinburgh, Scotland (Press Release) – Iceni Pharma­ceu­ticals announces its launch as a new com­pany, focusing on devel­op­ing repurposed and reformulated cancer ther­a­pies. The com­pany’s lead prod­uct Cilcane^® (generic name cilengitide) is being repurposed by Iceni as a first-in-class treat­ment for multiple myeloma. Iceni has dem­onstrated in pre-clinical studies that Cilcane^® is effective as a com­bi­na­tion ther­apy when given with pro­te­a­some inhibitors such as bor­tez­o­mib, and that this ap­proach may also be appli­­cable to breast and other cancers. Iceni has a broad …

First-in-class CD38-directed active immuno­therapy provides new treat­ment option for MM patients who have exhausted other approved treat­ment options

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted con­di­tional approval to DARZALEX® (dara­tu­mu­mab) for mono­therapy of adult patients with re­lapsed and refractory multiple myeloma (MM), whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy. Dara­tu­mu­mab was approved under an accelerated assess­ment, a process reserved for medicinal prod­ucts ex­pec­ted to be of major public health interest, particularly from the point of view of thera­peutic inno­va­tion.¹

Daratumumab is the first …