Carfilzomib Application For FDA Approval Is Delayed
Onyx Pharmaceuticals announced today that it is delaying for at least six months its application to market carfilzomib, a new treatment for multiple myeloma, in the United States.
Prior to today’s announcement, Onyx had expected to submit carfilzomib’s new drug application to the U.S. Food and Drug Administration (FDA) by the end of this year.
Now the company says its application will be submitted “as early as mid-year 2011.”
In its announcement today, Onyx explained that the delay in carfilzomib’s U.S. marketing timeline is due to an FDA request for additional information about manufacturing plans for the drug.
This request, in turn, was sparked by tests that revealed “variations” in the carfilzomib being produced using new manufacturing processes Onyx is implementing.
The company is emphasizing that the new marketing timeline for carfilzomib is not due to any change in the expected efficacy or safety of the drug. Onyx says that “Phase 3 trials [of carfilzomib] are on schedule and actively enrolling patients, and this change is not expected to impact any of the carfilzomib trials.”
Carfilzomib works similarly to the existing multiple myeloma treatment Velcade (bortezomib) by preventing the breakdown of protein in cancer cells, triggering their death.
Along with pomalidomide – a chemical relative of multiple myeloma drugs Revlimid (lenalidomide) and thalidomide (Thalomid) – carfilzomib is considered one of the most promising myeloma treatments that could be approved by the FDA in the next few years.
Based on the new application timeline for carfilzomib and assuming no further delays in the application and approval process, the drug should be available for sale in the United States in the first half of 2012. Onyx has not yet announced a timeline for the marketing of carfilzomib elsewhere in the world.
For further details on today’s announcement by Onyx, please see the company’s press release. For several articles summarizing recent carfilzomib trial results, see The Myeloma Beacon’s coverage of the ASCO 2010 annual meeting.
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The government are not only crooks and liars; they are also killers. They are killing my father by putting off realasing this drug. He has multiple myeloma and he will die if he cannot get this drug before his cancer grows. America is a horrible country and it disgust me. My father got cancer from agent orange expisurebun the Vietnam war. And now the FDA is interfering in the treatment if many dying cancer patients just like they killed tons of brain cancer patients by offsetting releasement of the vaccine. Ted Kennedy wouldve been alive today. My mother is dead and if my father dies before this drug is released I will leave this worthless country. They make people pay thousands for medical insurance that screw them over and all politicians do in this country is baby big business and rob middle class Americans.
UAMS in Little Rock has a trial study with this drug - don't give up until you have explored all his options. Channel your anger into finding a solution.
I hope you don't give up, though it seems a steep uphill climb.
In the early 1990s, when lots of people with AIDS were "slated" to die, Act-Up created lots of pressure on pharmaceutical companies -- and the FDA -- to release promising, potentially life-saving drugs early, on a "compassionate use" nasis. That saved many lives, including my best friend, who is still alive and very much licking today, over 15 years later.
It's a different world now, and the gay community was poised to fight back at the time, but maybe there's a way to pressure the powers-that-be who have life-extending products that are just out of reach.
Best of luck.
P.S. My friend is alive and licking, but -- more often -- kicking.
There is also success at a trial at the Univ. of Mich. with excellent results. They are looking for participants.