FDA Worried About Efficacy and Safety of Carfilzomib Cancer Treatment

Posted on June 18, 2012

The Food and Drug Administration has expressed concerns that a drug seeking approval might be more trouble than it’s worth.

The drug being considered for approval is known as carfilzomib.  Its makers, Onyx Pharmaceuticals, were hoping that they could get the drug approved for the treatment of multiple myeloma, a rare type of cancer that compromises plasma cells in a person’s body.  The new drug, which would be marketed as Kyprolis, would be offered to those persons who haven’t responded well to drugs already on the market.  Those drugs include Velcade, Thalomid, and Revlimid.

There are two main reasons that the FDA isn’t confident in the ability of the drug to safely do what it purports to do.  First, the safety organization has said that the drug-maker failed to prove that persons in a clinical trial did not have success with seven other types of treatment already available for those afflicted with multiple myeloma.

Second, the FDA worries that the new drug has side effects that are far more dangerous than those of the drugs already available.  Although 22% seemed to respond favorably to carfilzomib, numerous persons reportedly sustained severe side effects as a result of its administration.  There apparently exists a danger of heightened toxicity levels, as well as death.

An advisory panel will convene on June 20 to decide whether or not to recommend the drug.

How Can We Help You?

If you have a legal matter you would like to discuss with an attorney from our firm, please call us at (310) 477-1700 or complete and submit the e-mail form below, and we will get back to you.

  • This field is for validation purposes and should be left unchanged.
  • This field is for validation purposes and should be left unchanged.

*Required Fields