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 …

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 …

• The FDA did not identify any clin­i­cal deficiency in the CRL
• Company plans to meet with FDA and seek clarification on the CRL

Henderson, NV (Press Release) – Spectrum Pharma­ceu­ticals (NasdaqGS: SPPI), a bio­technology com­pany with fully integrated commercial and drug devel­op­ment operations with a pri­mary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Admin­istra­tion (FDA). A Complete Response Letter is a communication from the FDA that informs com­pa­nies that an appli­ca­tion …

-- Plenary Presentation at the 15th Inter­na­tional Myeloma Workshop --

Toronto, ON and San Diego, CA (Press Release) – Triphase Accelerator Corpo­ra­tion, a private drug de­vel­op­ment com­pany dedicated to ad­vanc­ing novel com­­pounds through Phase 2 proof-of-concept, today an­nounced pre­lim­i­nary results of a Phase 1 dose-escalation study of marizomib in com­bi­na­tion with poma­lido­mide (POM) and low dose dex­a­meth­a­sone (Lo-DEX) in patients with re­lapsed and refractory multiple myeloma. The marizomib/POM/Lo-DEX com­bi­na­tion was able to de­crease myeloma proteins by at least 50 per­cent to achieve an over­all response rate of 62 per­cent in …

Pivotal Study Demonstrated Kyprolis® (Carfilzomib) in Combination With Standard of Care can Extend Time Patients Live Without Disease Progressing

BLINCYTO® (Blinatumomab) is First Bispecific T cell Engager (BiTE®) Antibody Construct to be Granted Positive CHMP Opinion

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions recommending market­ing authori­za­tion for:

Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy, and

BLINCYTO^® (blina­tumo­mab) as a con­di­tional market­ing authori­za­tion for the treat­ment of adults with Philadelphia chromosome-negative (Ph-) re­lapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

"We are pleased to receive positive CHMP …