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 …

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 poten­tial new myeloma ther­apy daratumumab just got a little closer to being avail­able to U.S. multiple myeloma patients outside of clin­i­cal trials.

Johnson and Johnson (NYSE:JNJ) announced today that its Janssen sub­sid­i­ary has started the process of applying to the U.S. Food and Drug Admin­istra­tion (FDA) to have dara­tu­mu­mab approved as a new treat­ment for re­lapsed multiple myeloma.

In particular, Johnson and Johnson has started a rolling sub­mission of a biologics license appli­ca­tion to the FDA for dara­tu­mu­mab.

A rolling sub­mission allows Johnson and Jonson to submit com­pleted portions of …

The U.S. Food and Drug Administration (FDA) on Monday approved Farydak (panobinostat) for the treatment of multiple myeloma (see related Beacon news).

Since the FDA announced its decision, multiple myeloma patients, care­givers, and health care professionals have been asking a number of important questions about Farydak. This article compiles many of those questions and provides answers to them.

The information in this article is based primarily on the official, FDA-approved prescribing information for Farydak. In addition, The Beacon has received feedback in regard to several questions …

The U.S. Food and Drug Administration (FDA) has approved panobinostat, which will be marketed under the brand name Farydak, for the treatment of relapsed and refractory multiple myeloma.

Specifically, Farydak has been approved for use in combination with Velcade (bortezomib) and dexamethasone (Decadron) in patients with multiple myeloma who have received at least two prior standard therapies.

The two prior therapies must include Velcade and at least one treatment from the immunomodulatory class of drugs, which includes Revlimid (lenalidomide), thalidomide, and Pomalyst (pomalidomide, Imnovid). …

Silver Spring, MD (Press Release) - The U.S. Food and Drug Admin­istra­tion today approved Farydak (panobinostat) for the treat­ment of patients with multiple myeloma.

Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approx­i­mately 21,700 Americans are diag­nosed with multiple myeloma and 10,710 die from the disease annually.

Primarily affecting older adults, multiple myeloma causes plasma cells to rapidly multiply and crowd out other healthy blood cells from the bone marrow. When …