Toronto (Press Release) - Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma. Health Canada will review the sub­mission with ad­vance con­sid­er­a­tion under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) mono­therapy study.

Daratumumab is a new class of ther­apy – a human anti-CD38 mono­clonal anti­body. It received Break­through Therapy Desig­na­tion and the Biologics License Application (BLA) was granted priority review and accelerated approval by …

The United States Food and Drug Admin­istra­tion (FDA) has approved dara­tumu­mab for the treat­ment of multiple myeloma. The drug will be mar­keted under the brand name Darzalex. It is ex­pec­ted to be avail­able at U.S. treat­ment centers and doctor’s offices within two weeks.

The FDA approved Darzalex for use in multiple myeloma patients who have pre­viously been treated with drugs in both the immuno­modu­la­tory and protea­some inhibitor classes of ther­a­pies. Drugs in the immuno­modu­latory class in­clude Revlimid (lena­lido­mide), thalido­mide (Thalomid), and Pomalyst …

First-in-class immuno­therapy approved for multiple myeloma patients who have received three or more prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent or who are double refractory to a PI and immuno­modu­la­tory agent

Horsham, PA (Press Release) – Janssen Biotech, Inc., a Janssen Pharma­ceu­tical Company of Johnson & Johnson, announced today the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX^® (dara­tu­mu­mab) injection for in­tra­venous in­fusion 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, or who are double-refractory to a PI and an immuno­modu­la­tory agent.¹ This indi­ca­tion is approved under accelerated approval based on response rate. Continued approval for this indi­ca­tion may be contingent upon veri­fi­ca­tion …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA for heavily pre-treated or double refractory multiple myeloma
• First mono­clonal anti­body approved for multiple myeloma
• Financial guidance updated to in­clude USD 45 million mile­stone pay­ment

Copenhagen, Denmark (Press Release) – Genmab A/S (OMX: GEN) announced today the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX™ (dara­tu­mu­mab) injection for in­tra­venous in­fusion 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 IMiD.¹ This indi­ca­tion is approved under accelerated approval based on response rate. Continued approval for this indi­ca­tion may be …

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 …