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Discussion about multiple myeloma treatments, stem cell transplants, clinical trials, alternative medicines, supplements, and their benefits and side effects.

pomalidomide

by jade on Sat Mar 10, 2012 1:35 pm

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.

jade

Re: pomalidomide

by smjson on Sat Mar 10, 2012 5:32 pm

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.

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

by Dr. Edward Libby on Sat Mar 17, 2012 1:16 pm

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 !

Dr. Edward Libby
Name: Edward Libby, M.D.
Beacon Medical Advisor

Re: pomalidomide

by suzierose on Sat Mar 17, 2012 1:46 pm

"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/

suzierose
Name: suzierose
When were you/they diagnosed?: 2 sept 2011

Re: pomalidomide

by suzierose on Sat Mar 17, 2012 1:56 pm

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?

suzierose
Name: suzierose
When were you/they diagnosed?: 2 sept 2011

Re: pomalidomide

by Dr. Edward Libby on Sun Mar 18, 2012 11:48 am

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.

Dr. Edward Libby
Name: Edward Libby, M.D.
Beacon Medical Advisor

Re: pomalidomide

by suzierose on Sun Mar 18, 2012 12:54 pm

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...

suzierose
Name: suzierose
When were you/they diagnosed?: 2 sept 2011

Re: pomalidomide

by TerryH on Sun Mar 18, 2012 4:04 pm

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.

TerryH

Re: pomalidomide

by Mark on Sun Mar 18, 2012 5:06 pm

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.

Mark

Re: pomalidomide

by suzierose on Sun Mar 18, 2012 5:24 pm

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?

suzierose
Name: suzierose
When were you/they diagnosed?: 2 sept 2011

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