Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted accelerated approval for Darzalex (dara­tu­mu­mab) to treat patients with multiple myeloma who have received at least three prior treat­ments. Darzalex is the first mono­clonal anti­body approved for treating multiple myeloma.

Multiple myeloma is a form of blood cancer that occurs in in­fec­tion-fighting plasma cells (a type of white blood cell) found in the bone marrow. These can­cer­ous cells multiply, produce an ab­nor­mal protein and push out other healthy blood cells from the bone marrow. The disease may result …

• CHMP grants accelerated assess­ment to dara­tu­mu­mab
• MAA submitted September 9 by Janssen based on data from Phase II study (Sirius MMY2002)

Copenhagen, Denmark (Press Release) – Genmab A/S (OMX: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assess­ment to the Marketing Authorization Application (MAA) for dara­tu­mu­mab. The MAA is for dara­tu­mu­mab as a treat­ment for patients with re­lapsed and refractory multiple myeloma. The MAA was submitted to the EMA on September 9, 2015 by Janssen-Cilag Inter­na­tional NV. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive world­wide license to …

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 accepted its re­quest for an accelerated assess­ment of the dara­tu­mu­mab Marketing Authorisation Application (MAA). This acceptance follows the earlier regu­la­tory sub­mission of a MAA which seeks authori­sa­tion of dara­tu­mu­mab as a single agent for the treat­ment of patients with re­lapsed and refractory multiple myeloma and is cur­rently pend­ing val­i­da­tion by the EMA.

The CHMP grants accelerated assess­ment when a medicinal prod­uct is ex­pec­ted to be …

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 …

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 …