Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion granted accelerated approval to Xpovio (selinexor) tablets in com­bi­na­tion with the corticosteroid dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is resistant to several other forms of treat­ment, in­clud­ing at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body.

“While there is no cure for multiple myeloma, there are FDA-approved treat­ments to target the cancer and slow down …

• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• First approval for DARZALEX in a frontline indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Appli­cation (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing part­ner, Janssen Biotech, Inc., in November 2017. The U.S. FDA sub­se­quently granted priority review to the …

• Expansion of Indication Offers Patients a New Treatment Option
• Approval Based on Safety and Efficacy Data From the Largest Inter­na­tional Multiple Myeloma Clinical Trial Ever Conducted

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the cur­rently approved indi­ca­tion for the prevention of skeletal-related events in patients with bone metastases from solid tumors to in­clude patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 '482 study, the largest inter­na­tional multiple myeloma clin­i­cal trial ever conducted, which enrolled 1,718 patients.

"Up to …

DARZALEX com­bi­na­tion ther­apy offers a new option for patients pre­vi­ously treated with two commonly used treat­ments (lena­lido­mide and a pro­te­a­some inhibitor)

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the immuno­therapy DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing lena­lido­mide (an immuno­modu­la­tory agent) and a pro­te­a­some inhibitor (PI).¹ Clinical trial results showed an over­all response rate (ORR) of 59.2 per­cent with DARZALEX in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone in these patients.¹

DARZALEX is the first CD38-directed anti­body approved any­where in the world.² It was …

• DARZALEX sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) in com­bi­na­tion with two standard of care regi­mens versus standard of care regi­mens alone
• Approval based on two Phase 3 studies showing con­sis­tent and pronounced clin­i­cal benefit of DARZALEX in com­bi­na­tion with two of the most widely used treat­ment classes for multiple myeloma

Horsham, PA (Press Release) – Janssen Biotech, Inc. announced today the U.S. Food and Drug Admin­is­tra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) 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.¹ Clinical studies have shown that DARZALEX, in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone, reduced the risk of disease pro­gres­sion or death by 63 per­cent, com­pared to lena­lido­mide and dexa­meth­a­sone alone, in patients with …

Silver Spring, MD (Press Release) – The U.S. Food and Drug Admin­istra­tion today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with addi­tional kidney or lung ab­nor­mal­i­ties after they receive a stem cell trans­plant from blood or bone marrow called hematopoietic stem cell trans­plan­ta­tion (HSCT). This is the first FDA-approved ther­apy for treat­ment of severe hepatic VOD, a rare and life-threatening liver con­di­tion.

HSCT is a procedure per­formed in some patients to treat certain blood or bone marrow cancers. Immediately before an HSCT procedure, a …