Janssen Biotech, Inc. ini­ti­ates rolling sub­mission of BLA to U.S. FDA for dara­tu­mu­mab in double refractory multiple myeloma

Submission based on data from Phase II study (Sirius MMY2002)

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today its licensing partner Janssen Biotech, Inc. has ini­ti­ated a rolling sub­mission of a Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­tea­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­tea­some inhibitor and an IMiD. A rolling sub­mission allows com­pleted portions of the …

Marks a critical step for­ward for the inves­ti­ga­tional human mono­clonal anti­body (mAb)

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) has ini­ti­ated the rolling sub­mission of its Biologic License Application (BLA) for dara­tu­mu­mab to the U.S. Food and Drug Admin­is­tra­tion (FDA) 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 double refractory to a PI and an IMiD. Dara­tu­mu­mab – an inves­ti­ga­tional human anti-CD38 mono­clonal anti­body – received Break­through Therapy Desig­na­tion by the FDA for this set of patients …

The pivotal study will assess the efficacy of plitidepsin plus dexa­meth­a­sone versus dexamethasone alone in patients with re­lapsed / refractory multiple myeloma

Madrid (Press Release) – PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treat­ment of multiple myeloma, denominated ADMYRE, has been suc­cessfully com­pleted. The study, which originally planned to in­clude 250 patients, has enrolled 255 patients in 71 medical centers world­wide, in­­clud­ing the US, Europe, Asia, South America, Australia, and New Zealand. An appli­ca­tion for market­ing authori­za­tion in Europe is planned to be submitted in 2016.

ADMYRE …

Data from Once-Weekly CHAMPION Phase 1/2 Study Presented at ASCO

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the initiation of the ARROW trial, a global Phase 3 study eval­u­ating the benefit of Kyprolis® (car­filz­o­mib) for Injection ad­min­is­tered once-weekly with dexa­meth­a­sone versus the current U.S. Food and Drug Admin­istra­tion (FDA) approved twice-weekly admin­istra­tion schedule in patients with re­lapsed and refractory multiple myeloma who have received prior treat­ment with bor­tez­o­mib and an immuno­modu­la­tory agent (IMiD). The trial was ini­ti­ated based on results from the Phase 1/2 CHAMPION study, which were presented (abstract no. 8527) at the 51st Annual Meeting …

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced it has fulfilled the accelerated approval require­ments for POMALYST® (poma­lido­mide) based on results from MM-003, an inter­na­tional phase III study of POMALYST plus low-dose dex­a­meth­a­sone versus high-dose dex­a­meth­a­sone in re­lapsed / refractory multiple myeloma patients. POMALYST, in com­bi­na­tion with dex­a­meth­a­sone is ap­proved for patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing lena­lido­mide and a pro­te­a­some inhibitor and have dem­onstrated disease pro­gres­sion on or within 60 days of com­ple­tion of the last ther­apy.

"There remains a sig­nif­i­cant unmet need …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clin­i­cal stage bio­phar­ma­ceu­tical com­pany devel­op­ing inno­va­tive agents for the detection and treat­ment of cancer, an­nounced the ini­ti­a­tion of patient dosing in a proof-of-concept trial of I-131-CLR1404 in patients with re­lapsed or re­frac­tory mul­tiple myeloma, an indi­ca­tion for which I-131-CLR1404 pre­vi­ously re­ceived orphan drug desig­na­tion from the U.S. Food and Drug Admin­istra­tion.

Multiple myeloma is an incurable malig­nan­cy for which novel ther­a­pies are needed. The radiosensitivity of mul­ti­ple myeloma is well doc­u­mented. I-131-CLR1404 is de­signed to allow for targeted de­livery of ionizing radi­a­tion …

Toronto, ON (Press Release) – Teva Canada Limited, a sub­sid­i­ary of Teva Pharma­ceu­tical Industries Ltd., announced that Health Canada has approved its appli­ca­tion for the generic version of ^PrBortezomib for Injection for the fol­low­ing indi­ca­tions:

• As part of com­bi­na­tion ther­apy for the treat­ment of patients with pre­vi­ously untreated multiple myeloma who are unsuitable for stem cell trans­plan­ta­tion.
• For the treat­ment of progressive multiple myeloma in patients who have received at least one prior ther­apy and who

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