Daratumumab Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration in Combination with Standard of Care Regimens for Previously Treated Multiple Myeloma Copenhagen Stock Exch : globenewswire

referring to globenewswire

Daratumumab Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration in Combination with Standard of Care Regimens for Previously Treated Multiple Myeloma Copenhagen Stock Exch

Daratumumab Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration in Combination with Standard of Care Regimens for Previously Treated Multiple Myeloma Copenhagen Stock Exch

Company AnnouncementDaratumumab receives Breakthrough Therapy Designation in combination with standard of care regimens for multiple myeloma patients who have received at least one prior line of therapyPotential for accelerated reviewMarks second Breakthrough Therapy Designation for daratumumabCopenhagen, Denmark; July 26, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for DARZALEX® (daratumumab) injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.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.


not to mention seekingalpha

J&J's Darzalex a Breakthrough Therapy for earlier line of treatment for multiple myeloma - Johnson & Johnson (NYSE:JNJ)

J&J's Darzalex a Breakthrough Therapy for earlier line of treatment for multiple myeloma - Johnson & Johnson (NYSE:JNJ)

The FDA designates Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab) a Breakthrough Therapy, in combination with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy.Several months ago, the European Commission approved it as monotherapy in adults with relapsed/refractory MM whose prior therapy included a proteasome inhibitor [e.g.


by the same token on prnewswire

Daratumumab (DARZALEX®) Granted Breakthrough Therapy Designation by U.S. Food and Drug

Daratumumab (DARZALEX®) Granted Breakthrough Therapy Designation by U.S. Food and Drug

RARITAN, N.J., July 25, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to the immunotherapy daratumumab (DARZALEX®) in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy, Janssen Research & Development, LLC announced today.This marks the second time daratumumab has received a Breakthrough Therapy Designation, which is intended to expedite the development and review timelines of potential new medicines to treat serious or life-threatening diseases, where preliminary clinical evidence shows that the medicine may provide substantial improvement over existing therapies.1 Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.2,3"Despite tremendous progress in the past 15 years, multiple myeloma remains a highly complex and difficult disease to treat, with most patients relapsing or becoming resistant to therapy," said MMY3003 (POLLUX) lead study author Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece."Daratumumab has already shown pronounced activity as a monotherapy in heavily pre-treated patients.