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GSK and Genmab seek FDA approval for ofatumumab combination therapy for CLL first-line treatment
GlaxoSmithKline (GSK) and Genmab have submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy in patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment.
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GSK and Genmab seek FDA approval for ofatumumab combination therapy for CLL first-line treatment
Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration
May 1, 2013
Genmab A/S announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for daratumumab 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. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
Daratumumab is an investigational anti-cancer drug. It binds to CD38.Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab
Genmab: Daratumumab Granted Fast Track Designation By FDA
Monoclonal antibody
2/4/2013
Genmab A/S announced that the US Food and Drug Administration has granted Fast Track designation for daratumumab. This designation covers 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 are double refractory to a PI and an IMiD.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
Daratumumab is an investigational anti-cancer drug. It binds to CD38.[1] Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.[2]
Encouraging preliminary results were reported in June 2012 from a Phase 1/2 clinical trial in relapsed multiple myeloma patients.[3] Updated trial results presented in December 2012 indicate daratumumab is continuing to show promising single-agent anti-myeloma activity.[4]
- World Health Organization (2009). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 101” (PDF). WHO Drug Information 23 (2).
- “‘Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab'”. Janssen Biotech. Retrieved 2013-01-31.
- “ASCO: Drug Shows Promise in Myeloma”. MedPage Today.
- “‘Daratumumab Continues To Show Promise For Relapsed/Refractory Myeloma Patients (ASH 2012)'”. The Myeloma Beacon. Retrieved 2013-01-31.
MHLW Japan, GlaxoSmithKline and Genmab announced the approval of Arzerra (ofatumumab) by the MHLW for use in patients with relapsed/refractory CD20-positive chronic lymphocytic leukaemia.
mar 26, 2013
GlaxoSmithKline and Genmab announced the approval of Arzerra (ofatumumab) by the MHLW for use in patients with relapsed/refractory CD20-positive chronic lymphocytic leukaemia.
The thumbs-up triggers a milestone payment of 20 million Danish kroner to Genmab.
Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.