Carfilzomib (Kyprolis) Is Approved by FDA

Onyx Pharmaceuticals announced today that their investigational drug carfilzomib has been approved by the FDA for treatment of myeloma, and is now available for prescription by doctors under the trade name Kyprolis. Here is the Onyx press release.

Kyprolis is a proteazome inhibitor, which means that it works rather like Velcade does, but in studies it seemed to be at least as powerful and caused much less neuropathy. It is approved for patients who have received at least two prior therapies. In my (nonmedical) opinion, however, when doctors have gained confidence in Kyprolis’ efficacy and safety, they will begin to prescribe it for newly-diagnosed patients, as they have done with other drugs.

In particular, a recently-published study has shown that Kyprolis in combination with Revlimid and dexamethasone produced a 100% response in newly-diagnosed patients, with 64% of patients achieving a stringent complete response, meaning that their myeloma was undetectable.  In my (nonmedical) opinion, this combination will be hard for doctors to resist.

Kyprolis is administered in a 2- to 10-minute infusion in a clinical setting.  It is the first-approved of two innovative and potent drugs recently submitted for approval to the FDA.  The other is pomalidomide, by Celgene, an oral drug (a little pill taken at home) which will hopefully be approved in early 2013.  Pomalidomide has kept my own myeloma stable for well over four years now.

Right now the cure for myeloma is to stay alive long enough to die of something else.  Kyprolis, and soon pomalidomide, will give us two more tools to make that happen.  Lots more is happening in the labs.  Stick around, there is hope!