Die US-Bundesbehörde zur Überwachung von Nahrungs- und Arzneimitteln (FDA) hat Daratumumab für die Behandlung des multiplen Myeloms zugelassen. Das Medikament wird unter dem Markennamen Darzalex auf den Markt gebracht und voraussichtlich innerhalb von zwei Wochen in den US-amerikanischen Behandlungszentren und Arztpraxen verfügbar sein.

Die FDA hat Darzalex für die Anwendung bei Myelompatienten zugelassen, die vorher sowohl mit Immunmodulatoren als auch Proteasomenhemmstoffen behandelt worden sind. Immunmodulatorische Medikamente umfassen Revlimid (Lenalidomid), Thalidomid und Pomalyst (Pomalidomid, Imnovid). Medikamente der Proteasomenhemmstoffklasse schließen Velcade (Bortezomib) und Kyprolis (Carfilzomib) ein.

Die FDA-Zulassung von Darzalex ist genauer gesagt für …

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 …