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 …

-- 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 …

All Evaluable Patients to Date See Evidence of an Objective Response; Treatment Combination Associated with Statistically Significant Upregulation of PD-L1

Calgary, AB (Press Release) – Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC) (NASDAQ: ONCY) today announced that Dr. D.W. Sborov and colleagues made a poster presentation at the 15th Inter­na­tional Myeloma Workshop (IMW). The poster presentation, entitled "Combination Carfilzomib and the Viral On­co­lytic Agent REOLYSIN^® in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Pro­lifer­a­tion," discloses initial findings from a pilot study (NCI-9603) in patients with re­lapsed or refractory multiple …

• 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 …