Tag Archives: multiple myeloma

Ixazomib

Ixazomib

FDA approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome
inhibitor. November 20, 2015. More Information:
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm473804.htm

Advertisements

Drug Information Update – FDA approves new oral medication to treat multiple myeloma

Drug Information Update – FDA approves new oral medication to treat multiple myeloma
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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 cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

The most common side effects of Ninlaro are diarrhea, constipation, low blood platelet count (thrombocytopenia), peripheral neuropathy (numbness and pain from nerve damage, usually in the hands and feet), nausea, peripheral edema (fluid under the skin causing swelling), vomiting and back pain.

For more information, please visit: Ninlaro

Daratumumab injection

Daratumumab injection
The U.S. Food and Drug Administration granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), administered as a single agent 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. November 16, 2015. More Information:
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm