CIENCIASMEDICASNEWS: Drug Information Update - FDA approves new drug for patients with previously treated multiple myeloma

martes, 17 de noviembre de 2015

Drug Information Update - FDA approves new drug for patients with previously treated 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 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 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 Darzalex were infusion-related reactions, fatigue, nausea, back pain, fever and cough. Darzalex may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia) and low levels of blood platelets (thrombocytopenia).

Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion. Women who are pregnant should not use Darzalex, and women planning to become pregnant should use effective contraceptives during and for at least three months after treatment.

For more information, please visit: Darzalex

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at druginfo@fda.hhs.gov.

For additional drug information, please visit the DDI Web page.
For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info.
This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).