[quote]?Kyprolis? Is Proposed Brand Name For Carfilzomib – by The Myeloma Beacon Staff
Onyx Pharmaceuticals has proposed ?Kyprolis? as the trademarked brand name for carfilzomib. The name was announced this morning by the U.S. Food and Drug Administration (FDA).
The FDA confirmed in the announcement that the agency?s Oncologic Drugs Advisory Committee, which advises the FDA during its review of potential new cancer drugs, will discuss the new drug application for Kyprolis (carfilzomib) on June 20. Onyx, the company developing carfilzomib, announced the review date last week.
The official use of carfilzomib that the committee will be discussing is for the treatment of patients with relapsed and refractory (recurring and resistant) multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor ? such as Velcade (bortezomib) ? and an immunomodulatory agent ? such as Revlimid (lenalidomide), thalidomide (Thalomid), or pomalidomide.
Pharmaceutical companies such as Onyx discuss a new drug?s proposed brand name with the FDA during the agency?s review of a drug. Brand names are not typically finalized, however, until after a drug has been approved by the FDA and is ready to be launched for general use.
The FDA advisory committee meeting on June 20 will be open to the public, and a live webcast will be available. [/quote]
Well things seem to be moving forward quite quickly for Carfilzomib… although the world-wide trials continue, Onyx, the parent company, are pressing ahead with licensing and, apparently, the naming process. This is good news for anyone who, as stated above, have had at least two prior lines of therapy… including a proteasome inhibitor ? such as Velcade and an immunomodulatory agent such as Revlimid, thalidomide (Thalomid), or pomalidomide.
I just failed to get on the trial in March and had to settle for the 'blind' part of the trial which is Rev & Dex but my consultant was very positive, almost bullish about the properties of Carfilzomib… so there looks like being a ray of light… if not just around the corner at least just around the block.
Good, good.:-) 😎
Dai.
Mari 12 years, 7 months ago.
