Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for dara­tu­mu­mab, an in­ves­ti­ga­tional, human anti-CD38 mono­clonal anti­body, for the treat­ment of patients with re­lapsed and refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ised by excess growth and survival of malignant plasma cells.^[1] Patients who are refractory to both pro­te­a­some inhibitors (PIs) or immuno­modu­la­tory agents (IMiDs) have a poor prognosis, with an esti­mated median over­all survival of …

If approved, dara­tu­mu­mab will offer a new option for double refractory, heavily pre-treated patients

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for Priority Review the Biologics License Application (BLA) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who are refractory to both a pro­tea­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who have received three or more prior lines of ther­apy, in­­clud­ing a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has be­come resistant to at least …

• U.S. FDA grants Priority Review to dara­tu­mu­mab
• PDUFA target date has been set to March 9, 2016

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the Biologics License Application (BLA) for dara­tu­mu­mab. The BLA 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 BLA sub­mission was started by Genmab’s …

• Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1]
• In clinical trials, Farydak combination increased PFS by 7.8 months in patients who received >=2 prior regimens, including bortezomib and an IMiD[1]
• As the first HDAC inhibitor approved in the EU for multiple myeloma, Farydak may help reset key cell function in multiple myeloma through epigenetic activity[2]
• Farydak is approved in the US and Japan

 …

This ac­ceptance for review marks the first in the U.S. for a SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for priority review the Biologics License Appli­ca­tion (BLA) for Empliciti (elo­tuzu­mab), an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­nation ther­apy in patients who have re­ceived one or more prior ther­a­pies. Empliciti was pre­vi­ously granted Break­through Therapy Desig­na­tion, which ac­cord­ing to the FDA, is in­tended to expedite the devel­op­ment and review of drugs for serious or life-threatening con­di­tions. The Euro­pean Medicines …

Hyderabad, India (Press Release) – Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced that it has entered into a strategic col­lab­o­ration with Amgen – one of the world’s leading independent bio­technology com­pa­nies – to mar­ket and distribute three Amgen med­i­cines in India in the areas of on­col­ogy and cardiology. Under the terms of the col­lab­o­ration, Dr. Reddy’s shall per­form a full range of regu­la­tory and commercial services to seek approval and launch Kyprolis® (car­filz­o­mib), BLINCYTO® (blinatumomab) and Repatha™ (evolocumab) in India. The col­lab­o­ration leverages the capabilities of both com­pa­nies, combining three of Amgen’s inno­va­tive ther­a­pies …

Results from two clin­i­cal trials (ELOQUENT-2 & CA204-009), each combining Empliciti with a dif­fer­en­t standard of care regi­men in­cluded in the sub­mission

Empliciti is poised to be the first-in-class SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the Euro­pean Medicines Agency (EMA) val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion (MAA) for Empliciti, an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy in adult patients who have re­ceived one or more prior ther­a­pies. The appli­ca­tion was granted ac­cel­er­ated assess­ment by the EMA’s Com­mit­tee for Medicinal Products for Human Use (CHMP).

“We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for …