Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced this morning that the U.S. Food and Drug Administration (FDA) has accepted the com­pany's New Drug Applica­tion for car­filz­o­mib.

The announcement means that the FDA will now begin its full review of carfilzomib ^[1] (Kyprolis ^[2]).

The length of time required for that review depends on whether the FDA grants the drug what is known as "priority review."

If car­filz­o­mib is granted priority review, the FDA will aim to make a decision on the application by the end of next March.  A positive decision by the FDA at that point in time would allow Onyx to begin marketing car­filz­o­mib in the United States as a new treat­ment for re­lapsed and refractory myeloma.

A negative decision would delay the launch of car­filz­o­mib until Onyx is able to address any questions or concerns raised by the FDA.

An Onyx spokesperson told The Beacon that the com­pany expects an FDA decision about priority review within the next several weeks.  In addi­tion, the spokesperson said that Onyx cur­rently expects car­filz­o­mib to be approved sometime during the first half of next year.

Until car­filz­o­mib receives FDA approval, the drug is available through Onyx’s expanded access pro­gram ^[3] for re­lapsed and refractory myeloma patients in the U.S. who do not have any other treat­ment options.

Carfilzomib works similarly to the existing multiple myeloma treat­ment Velcade ^[4] (bor­tez­o­mib) by preventing the breakdown of protein in cancer cells, triggering their death.

Along with pomalidomide ^[5] – a chemical relative of multiple myeloma drugs Revlimid ^[6] and thalidomide ^[7] (Thalomid) – car­filz­o­mib is considered one of the most promising new myeloma treat­ments that could be approved by the FDA in the next few years.

For more in­­for­ma­tion, see the Onyx ^[8] press release.