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FDA approval of Kyprolis at 56 mg/m2 ?
Right now there are various trials underway, or which have been completed, using Kyprolis (carfilzomib) at 56 mg/m2. Does anybody know if or when the FDA might give final approval for Kyprolis at 56 mg/m2 outside of a clinical trial? Is this possible anytime in the next year, or is the earliest possible approval more than a year away?
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
Re: FDA approval of Kyprolis at 56 mg/m2 ?
Eric,
Correct me if I'm wrong, but since you are in the USA, your doc can prescribe whatever dose and frequency he/she pleases ("off label", that is), whether the dose is FDA approved or not.
Correct me if I'm wrong, but since you are in the USA, your doc can prescribe whatever dose and frequency he/she pleases ("off label", that is), whether the dose is FDA approved or not.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: FDA approval of Kyprolis at 56 mg/m2 ?
He could, I suppose, but he will not. I believe it is part of my HMO's policy to stick within FDA approval or guidelines unless it is a trial. Probably helps prevents malpractice lawsuits. It is my understanding that many insurance companies also only approve within FDA guidelines.
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
Re: FDA approval of Kyprolis at 56 mg/m2 ?
Eric,
Insurance companies will pay for drugs used off label, but you have to fight! A lot of times they require additional documentation, including peer reviewed articles, showing that the treatment is valid. Your doc's insurance people should be able to help you with this, if your doc thinks its a viable option for you.
Lyn
Insurance companies will pay for drugs used off label, but you have to fight! A lot of times they require additional documentation, including peer reviewed articles, showing that the treatment is valid. Your doc's insurance people should be able to help you with this, if your doc thinks its a viable option for you.
Lyn
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Christa's Mom - Name: Christa's Mom
- Who do you know with myeloma?: Husband
- When were you/they diagnosed?: September, 2010
- Age at diagnosis: 53
Re: FDA approval of Kyprolis at 56 mg/m2 ?
Hi Eric,
I believe I got back to you via private message on this issue a while back, but I wanted to follow up here so that the information I have is available for everyone.
The short answer to your question is that there probably won't be an FDA approval for higher-dose Kyprolis within the next year or so.
Amgen earlier this year requested an update to the Kyprolis prescribing information so that it reflects results from the ASPIRE trial, which compared Kyprolis, Revlimid, and dexamethasone to Revlimid and dex alone (related Amgen press release). However, the Kyprolis dose in that study was the same as the 20/27 mg/m2 recommendation in the current Kyprolis prescribing information.
A higher dose of Kyprolis was tested in the ENDEAVOR trial, which compared Kyprolis and dexamethasone with Velcade and dexamethasone in relapsed myeloma patients (related Beacon news article). I'm not aware of any plans in the near future, however, for Amgen to ask the FDA to change the Kyprolis prescribing information based on the results of this study. Even if it did, it could take up to a year for a decision to be made on such an application.
So, as I said, I don't think there will be any change soon in the dosing of Kyprolis recommended in the U.S. prescribing information for the drug.
It's true, as others have pointed out, that doctors can request that insurance companies in the U.S. permit alternative dosing of drugs. Many doctors will do that, and the requests often are approved. The situation gets complicated, however, in situations where the doctor is employed by the insurance company. If I recall correctly, you're with Kaiser, so you are in this situation, and Kaiser does tend to require its doctors to stick with the drug dosing in the official prescribing information.
As a final P.S., although much of what I've written above is based on my own knowledge of where things stand with Kyprolis, I did check with our press contact at Amgen to make sure I wasn't missing anything. The press people, of course, can only relay what Amgen already has said publicly about the company's plans, but the feedback I received is in line with what I've written above.
I believe I got back to you via private message on this issue a while back, but I wanted to follow up here so that the information I have is available for everyone.
The short answer to your question is that there probably won't be an FDA approval for higher-dose Kyprolis within the next year or so.
Amgen earlier this year requested an update to the Kyprolis prescribing information so that it reflects results from the ASPIRE trial, which compared Kyprolis, Revlimid, and dexamethasone to Revlimid and dex alone (related Amgen press release). However, the Kyprolis dose in that study was the same as the 20/27 mg/m2 recommendation in the current Kyprolis prescribing information.
A higher dose of Kyprolis was tested in the ENDEAVOR trial, which compared Kyprolis and dexamethasone with Velcade and dexamethasone in relapsed myeloma patients (related Beacon news article). I'm not aware of any plans in the near future, however, for Amgen to ask the FDA to change the Kyprolis prescribing information based on the results of this study. Even if it did, it could take up to a year for a decision to be made on such an application.
So, as I said, I don't think there will be any change soon in the dosing of Kyprolis recommended in the U.S. prescribing information for the drug.
It's true, as others have pointed out, that doctors can request that insurance companies in the U.S. permit alternative dosing of drugs. Many doctors will do that, and the requests often are approved. The situation gets complicated, however, in situations where the doctor is employed by the insurance company. If I recall correctly, you're with Kaiser, so you are in this situation, and Kaiser does tend to require its doctors to stick with the drug dosing in the official prescribing information.
As a final P.S., although much of what I've written above is based on my own knowledge of where things stand with Kyprolis, I did check with our press contact at Amgen to make sure I wasn't missing anything. The press people, of course, can only relay what Amgen already has said publicly about the company's plans, but the feedback I received is in line with what I've written above.
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Boris Simkovich - Name: Boris Simkovich
Founder
The Myeloma Beacon
Re: FDA approval of Kyprolis at 56 mg/m2 ?
Interesting that I have been reading about more and more trials of one sort of the other with Kyprolis at doses higher than 20/27 mg/m2, but yet no plan for FDA approval above that dose. Seems strange.
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
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