The United States Food and Drug Admin­istra­tion (FDA) has approved elotuzumab for the treat­ment of mul­ti­ple myeloma.

The drug will be sold under the brand name Empliciti, and it will be mar­keted by the U.S. pharma­ceu­tical com­pany Bristol-Myers Squibb. The com­pany said in a press re­lease issued this Monday that it will begin shipping Empliciti “within the next 48 hours.”

Empliciti’s ap­prov­al is for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) in mul­ti­ple myeloma patients who have re­ceived one to three prior ther­a­pies.

There …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted ap­prov­al for Empliciti (elo­tuzu­mab) in com­bi­na­tion with two other ther­a­pies to treat people with mul­ti­ple myeloma who have re­ceived one to three prior medi­ca­tions.

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. This dis­ease may re­­sult in a weakened im­mune sys­tem, and …

The United States Food and Drug Admin­istra­tion (FDA) has approved ixazomib for the treat­ment of multiple myeloma.

The drug will be marketed under the brand name Ninlaro. It should be avail­able in U.S. pharmacies by the middle of next month, according to a spokesperson from Takeda Oncology, the com­pany that developed Ninlaro and will be mar­ket­ing it globally.

Ninlaro is the second new multiple myeloma ther­apy approved by the FDA this week. The agency on Monday announced the approval of Darzalex (dara­tu­mu­mab) for the treat­ment of myeloma …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted approval for Ninlaro (ixazomib) in com­bi­na­tion with two other ther­a­pies to treat people with multiple myeloma who have received at least one prior ther­apy.

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 in a weakened immune system and …

The United States Food and Drug Admin­istra­tion (FDA) has approved dara­tumu­mab for the treat­ment of multiple myeloma. The drug will be mar­keted under the brand name Darzalex. It is ex­pec­ted to be avail­able at U.S. treat­ment centers and doctor’s offices within two weeks.

The FDA approved Darzalex for use in multiple myeloma patients who have pre­viously been treated with drugs in both the immuno­modu­la­tory and protea­some inhibitor classes of ther­a­pies. Drugs in the immuno­modu­latory class in­clude Revlimid (lena­lido­mide), thalido­mide (Thalomid), and Pomalyst …

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 …