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pomalidomide
Does anyone have a clear idea what is taking pomalidomide [Pomalyst] so long to be approved? It clearly works,it's been in trials for a long time and the side effects are no worse the the other meds. There are many people out there who don't qualify for trials who deserve a shot with this new drug. This is very unfair.
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jade
Re: pomalidomide
I read where it is expected to be approved later this year. I'm sorry but I do not have the specifics regarding date of approval.
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smjson - Name: Steven Mark Johnson
- Who do you know with myeloma?: myself
- When were you/they diagnosed?: Nov 2003
- Age at diagnosis: 51
Re: pomalidomide
Hello from rainy, cold and wet Seattle,
The FDA manages all of the aspects of new drug approval. An article in Beacon says that pomalidomide might be available by the end of 2012. The FDA tries very hard to be sure that new drugs are safe and effective. To acomplish this takes time. I am hopeful we will have Poma soon but.....I never count on the FDA to approve any drug at any time. You never know what they will find that might delay the release of a drug or even keep it from ever being released. This is for the good of our patients as frustrating as it is.
Best of luck !
The FDA manages all of the aspects of new drug approval. An article in Beacon says that pomalidomide might be available by the end of 2012. The FDA tries very hard to be sure that new drugs are safe and effective. To acomplish this takes time. I am hopeful we will have Poma soon but.....I never count on the FDA to approve any drug at any time. You never know what they will find that might delay the release of a drug or even keep it from ever being released. This is for the good of our patients as frustrating as it is.
Best of luck !
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Dr. Edward Libby - Name: Edward Libby, M.D.
Beacon Medical Advisor
Re: pomalidomide
"Under the FDA’s standard review process, the agency must decide whether to approve a drug within 10 months of the time the drug is submitted for review. However, the FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options. If the FDA grants pomalidomide priority review, the agency would need to complete its review of the drug within six months.
Thus, if the FDA approves pomalidomide based on the application Celgene submits this quarter, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013."
https://myelomabeacon.org/news/2012/01/26/celgene-updates-timeline-for-pomalidomide-approval-fda-ema/
Thus, if the FDA approves pomalidomide based on the application Celgene submits this quarter, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013."
https://myelomabeacon.org/news/2012/01/26/celgene-updates-timeline-for-pomalidomide-approval-fda-ema/
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: pomalidomide
Personally, I would rather have carfilzomide approved prior to pomalidomide, since there are already 2 IMIDs on the market, and we need another protesome inhibitor with reduce neuropathy.
Although, having an oral IMID would be good, it likely will not be covered by Medicaid.
"n its press release about the FDA standard review designation, Onyx explained that the FDA decided on a standard review for at least two reasons.
First, the FDA said that its advisory committee of outside oncology experts increasingly is recommending that the FDA not grant priority review unless a new drug application is based on a Phase 3 clinical trial.
This is not the case with the carfilzomib application, which is based on data from a Phase 2 trial. Phase 2 trials are smaller than Phase 3 clinical trials, and they are often not as scientifically rigorous as Phase 3 trials."
Perhaps one of the Beacon Advisors can tell us whether there are larger Phase 3 trials for pomalidomide already?
Or is this just the usual PHARMA politics, stalling approval of carfilzomib?
Although, having an oral IMID would be good, it likely will not be covered by Medicaid.
"n its press release about the FDA standard review designation, Onyx explained that the FDA decided on a standard review for at least two reasons.
First, the FDA said that its advisory committee of outside oncology experts increasingly is recommending that the FDA not grant priority review unless a new drug application is based on a Phase 3 clinical trial.
This is not the case with the carfilzomib application, which is based on data from a Phase 2 trial. Phase 2 trials are smaller than Phase 3 clinical trials, and they are often not as scientifically rigorous as Phase 3 trials."
Perhaps one of the Beacon Advisors can tell us whether there are larger Phase 3 trials for pomalidomide already?
Or is this just the usual PHARMA politics, stalling approval of carfilzomib?
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: pomalidomide
There are no Phase III trials of pomalidomide for myeloma currently open in the United States.
There a a few studies in Phase I/II around the country. These can be accessed on the NCI website.
There a a few studies in Phase I/II around the country. These can be accessed on the NCI website.
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Dr. Edward Libby - Name: Edward Libby, M.D.
Beacon Medical Advisor
Re: pomalidomide
Thanks Dr. Libby.
.... so no phase III trials for pomalidomide, yet it will get priority FDA review unlike carfilzomib, because the FDA wants phase III trials from Onyx for priority carfilzomib review despite their being inadequate treatment options?..geeeesh....
We don't need another IMID we need another protesome inhibitor.
...Celgene is just gleeful..about this.
Us poor multiple myeloma patients just gotta suffer while they count their cash.
I agree with Jade...it's just all so unfair...
.... so no phase III trials for pomalidomide, yet it will get priority FDA review unlike carfilzomib, because the FDA wants phase III trials from Onyx for priority carfilzomib review despite their being inadequate treatment options?..geeeesh....
We don't need another IMID we need another protesome inhibitor.
...Celgene is just gleeful..about this.
Us poor multiple myeloma patients just gotta suffer while they count their cash.
I agree with Jade...it's just all so unfair...
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: pomalidomide
Celgene has not even submitted an application to the FDA for approval of pomalidomide. They have said they will submit the application this quarter, but they haven't said anything yet whether they have submitted the application or not.
So there hasn't been a decision yet by the FDA about whether or not pomalidomide will get priority review.
So there hasn't been a decision yet by the FDA about whether or not pomalidomide will get priority review.
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TerryH
Re: pomalidomide
It is in Celgene's financial interest to wait to submit the application. They have the only other IMID's on the market. The longer they wait to submit the application, the longer they will have an IMID on patent. Thalidomide had disappointing sales last quarter - they will only get worse when pomalidomide gets approved. The reason Onyx is pushing so hard for Carfilzomib is because they want in to the Myeloma market. Celgene is in bed with the large Myeloma shops - UAMS, Dana-Farber and Mayo. It also helps those institutions if pomalidomide is not approved. The reason is more patients have to go to them to get access to the drug. That increases business fro UAMS, Mayo and Dana-Farber.
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Mark
Re: pomalidomide
Hi Mark!
How so? Lenalidomide does not go off patent, if pomalidomide comes on the market. Since Celegene is losing sales from thalidomide AND lenalidomide, they want pomalidoide on market pronto.
Celgene needs a new IMID drug for all those patients who are refractory to lenalidomide or have relapsed on that therapy. That population of multiple myeloma patients is very large vs. the newly diagnosed. So, the revenues would be greater treating the later with a new IMID, as they are presently losing those patients to newer agents that are not IMID's....thus any delay for a protesome inhibitor, means they do not have to compete for the refractory patient population.
Onyx should be in the multiple myeloma market..their drug is not only highly effective, but there is a large number of bortezomib refractory patients that need it. And those patients likely have peripheral neuropathy and carfilzomib has far less of that. Right, now those multiple myeloma patients, not in a clinical trial are stuck with highly myleosuppressive lenalidomide and the peripheral neuropathy of bortizomib if it still works for them.
One other thing, 23% of patients in the pom/dex trial were refractory to carfilzomib.
real bummer there
Do you think the academic institutions wouldn't make money from carfilzomib trials as well?
How so? Lenalidomide does not go off patent, if pomalidomide comes on the market. Since Celegene is losing sales from thalidomide AND lenalidomide, they want pomalidoide on market pronto.
Celgene needs a new IMID drug for all those patients who are refractory to lenalidomide or have relapsed on that therapy. That population of multiple myeloma patients is very large vs. the newly diagnosed. So, the revenues would be greater treating the later with a new IMID, as they are presently losing those patients to newer agents that are not IMID's....thus any delay for a protesome inhibitor, means they do not have to compete for the refractory patient population.
Onyx should be in the multiple myeloma market..their drug is not only highly effective, but there is a large number of bortezomib refractory patients that need it. And those patients likely have peripheral neuropathy and carfilzomib has far less of that. Right, now those multiple myeloma patients, not in a clinical trial are stuck with highly myleosuppressive lenalidomide and the peripheral neuropathy of bortizomib if it still works for them.
One other thing, 23% of patients in the pom/dex trial were refractory to carfilzomib.
real bummer there
Do you think the academic institutions wouldn't make money from carfilzomib trials as well?
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
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