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 (Kyprolis).

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 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 (bor­tez­o­mib) by preventing the breakdown of protein in cancer cells, triggering their death.

Along with pomalidomide – a chemical relative of multiple myeloma drugs Revlimid and thalidomide (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 press release.