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‘Kyprolis’ Is Proposed Brand Name For Carfilzomib

By: The Myeloma Beacon Staff; Published: April 30, 2012 @ 10:38 am | Comments Disabled

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 [1] (carfilzomib [2]) on June 20.  Onyx (NASDAQ: ONXX), the com­pany developing car­filz­o­mib, announced the review date last week (see related Beacon [3] news).

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 [4] (bor­tez­o­mib) – and an immuno­modu­la­tory agent – such as Revlimid [5] (lena­lido­mide), thalidomide [6] (Thalomid), or pomalidomide [7].

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.

For more in­­for­ma­tion, please see the FDA [8] announcement.


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URL to article: https://myelomabeacon.org/news/2012/04/30/kyprolis-carfilzomib-is-proposed-brand-name/

URLs in this post:

[1] Kyprolis: https://myelomabeacon.org/tag/Kyprolis/

[2] carfilzomib: https://myelomabeacon.org/tag/Carfilzomib/

[3] Beacon: https://myelomabeacon.org/news/2012/04/26/fda-sets-date-for-carfilzomib-advisory-board-meeting/

[4] Velcade: https://myelomabeacon.org/resources/2008/10/15/velcade/

[5] Revlimid: https://myelomabeacon.org/resources/2008/10/15/revlimid/

[6] thalidomide: https://myelomabeacon.org/resources/2008/10/15/thalidomide/

[7] pomalidomide: https://myelomabeacon.org/resources/2008/10/15/pomalidomide/

[8] FDA: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm302199.htm

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