[Katie]

Carfilzomib launch date / FDA approval?

by Katie on Mon Sep 12, 2011 4:43 pm

Does anyone here know when carfilzomib [Kyprolis] is supposed to get its FDA approval and launch in the U.S.?

[Dr. T]

Re: Carfilzomib launch date / FDA approval?

by Dr. T on Tue Sep 13, 2011 8:18 am

The company that is developing carfilzomib, Onyx Pharmaceuticals, has not yet said whether or not it has even applied to the FDA to have carfilzomib approved for sale in the U.S. It did say at some point last year that it expected to submit its application to the FDA as early as mid-2011. There has not yet been an announcement, however, whether an application has been submitted, and Onyx almost certainly has to announce this kind of news because its stock is publicly traded.

Once the application is submitted, it probably will take 6-12 months for the drug to be reviewed and, if all goes as Onyx hopes, approved.

I have heard that the application for approval probably will be submitted to the FDA in the next month or so. This would mean that approval and launch of the drug would take place in the spring of next year (2012).

Anything you read about this subject that isn't official, however, is basically based on hearsay, rumor, or speculation. You can't really know for sure unless the news is officially from Onyx. Unfortunately for the myeloma community, the company isn't providing a lot of official information on this important subject.

[Beacon Staff]

Re: carfilzomib launch date / FDA approval?

by Beacon Staff on Tue Sep 13, 2011 7:55 pm

Hi Katie,

We contacted Onyx Pharmaceuticals, the company developing carfilzomib, to get an official response to your questions. Here is what we were told by a company spokesperson:

"We [Onyx] plan to file the new drug application for carfilzomib in the relapsed and refractory setting under the accelerated approval pathway in the next few weeks. Pending FDA review and approval, we estimate the carfilzomib could be approved during the first half of next year. We are requesting priority review upon submission of the NDA."

Also, just as a reminder, Onyx has launched a so-called "expanded access program." The program makes it easier for myeloma patients with no other treatment options to get access to carfilzomib even before the drug is approved by the FDA.

You can read about the carfilzomib expanded access program in this set of Beacon Newsflashes:

https://myelomabeacon.org/news/2011/08/08/beacon-newsflashes-august-8-2011/

[Dr. T]

Re: carfilzomib launch date / FDA approval?

by Dr. T on Fri Dec 16, 2011 4:14 pm

Just to make sure this thread is kept current ... According to this article,

https://myelomabeacon.org/news/2011/12/09/spanish-experts-ask-what-is-the-path-to-a-cure-for-multiple-myeloma/

a decision by the FDA about carfilzomib's new drug application is due by the end of July, 2012.

The decision by the FDA will take one of three forms:.

1. "yes, carfilzomib -- you're approved",
2. "no, you're not approved -- yet ... give us some more data or answer some questions for us"
3. "no, you're not approved -- and we don't think there's much you can do to change our minds"

Outcome 3 is probably not going to happen.

The real question is whether option 1 or option 2 will happen.