Hi everyone,
This isn't necessarily earth shattering news, but we thought we would pass it along to everyone just so that you're all aware of it.
Millennium announced earlier this evening that the FDA has approved Velcade for the retreatment of multiple myeloma previously treated with Velcade.
We've got details of the news here at The Beacon in a press release from Millennium:
"FDA Approves Velcade® (bortezomib) Retreatment In Patients With Multiple Myeloma", Millennium press release, August 8, 2014.
Excerpts:
The FDA "has approved Velcade® (bortezomib) for the retreatment of adult patients with multiple myeloma (multiple myeloma) who had previously responded to Velcade therapy and relapsed at least six months following completion of prior Velcade treatment."
"The approved retreatment sNDA consisted of a Phase 2 study and other supportive data. The Phase 2 international RETRIEVE trial showed a 38.5 percent overall response rate (ORR) in multiple myeloma patients who had been previously treated with a VELCADE-based regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with Velcade retreatment was consistent with the known safety profile of intravenous Velcade in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment."
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Re: FDA approves Velcade for retreatment of myeloma
While I am all for providing a full arsenal of therapeutic tools for the Docs and providers, a couple of questions arise.
I presume this (Relapsed use) is so, for the reason that the latest studies/ research have listed the seemingly "best results' (TTP / PFS / OS) arises from multiple drug therapies--ie. Elonz / Pomalyst/Velcade/ dex, etc --Kyprolis/ Revlimid/ dex etc ?
Q: Should ALL Front-line therapies be automatically "reauthorized" for use, per Docs and Providers, by the FDA ? ( Subject to safety analysis)
The "Re-authorization " of front-line Therapies to use, or in conjunction with, relapsed multiple myeloma / resistant Treatment regimens seems to make sense, if one is using shot-gun approach therapies--due to the heterogenous nature of multiple myeloma . (ie. Barlogie method(s))
Do the studies bear this out ?
Or perhaps this is all just bound up in Patent protection and the extension thereof.?
Q: Are we now formally entering the "Combo me " or "Supersize that" era of multiple myeloma Novel therapies and abandoning the concept of Targeted Therapies ? (Non-transplant)
I presume this (Relapsed use) is so, for the reason that the latest studies/ research have listed the seemingly "best results' (TTP / PFS / OS) arises from multiple drug therapies--ie. Elonz / Pomalyst/Velcade/ dex, etc --Kyprolis/ Revlimid/ dex etc ?
Q: Should ALL Front-line therapies be automatically "reauthorized" for use, per Docs and Providers, by the FDA ? ( Subject to safety analysis)
The "Re-authorization " of front-line Therapies to use, or in conjunction with, relapsed multiple myeloma / resistant Treatment regimens seems to make sense, if one is using shot-gun approach therapies--due to the heterogenous nature of multiple myeloma . (ie. Barlogie method(s))
Do the studies bear this out ?
Or perhaps this is all just bound up in Patent protection and the extension thereof.?
Q: Are we now formally entering the "Combo me " or "Supersize that" era of multiple myeloma Novel therapies and abandoning the concept of Targeted Therapies ? (Non-transplant)
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Rneb
Re: FDA approves Velcade for retreatment of myeloma
Hi Rneb,
We're not sure exactly why Millennium went through the process of getting the FDA to approve this new use of Velcade. The indication doesn't really affect the extent to which U.S. doctors can prescribe Velcade in relapsed patients with prior exposure to Velcade therapy, since U.S. doctors generally have a fair amount of freedom to prescribe as they wish – particularly in relapsed patients.
We suspect that one motivation, however, may be just to increase awareness that Velcade is a option to consider for relapsed patients previously treated with Velcade (as demonstrated by the Phase 2 trial that enabled Millennium to convince the FDA to approve the new indication).
By increasing awareness of this option, Millennium may be able to get some doctors to treat patients again with Velcade rather than choosing to treat them with, say, Kyprolis (or Pomalyst).
We don't think protection from generic competition is a motivation because we don't think the new indication will delay the date when generic versions of Velcade can begin to be sold in the U.S..
One thing that did strike us as a bit odd is that the news of the new FDA approval was announced on a Friday evening in the midst of the August holiday season. We're not sure how to interpret that.
In any case, we wouldn't read too much "general" into this news. It is, we suspect, something specific to Velcade and the particular competitive pressures it is feeling.
Hope this helps shed a bit of light on the situation. Thanks for your comments.
We're not sure exactly why Millennium went through the process of getting the FDA to approve this new use of Velcade. The indication doesn't really affect the extent to which U.S. doctors can prescribe Velcade in relapsed patients with prior exposure to Velcade therapy, since U.S. doctors generally have a fair amount of freedom to prescribe as they wish – particularly in relapsed patients.
We suspect that one motivation, however, may be just to increase awareness that Velcade is a option to consider for relapsed patients previously treated with Velcade (as demonstrated by the Phase 2 trial that enabled Millennium to convince the FDA to approve the new indication).
By increasing awareness of this option, Millennium may be able to get some doctors to treat patients again with Velcade rather than choosing to treat them with, say, Kyprolis (or Pomalyst).
We don't think protection from generic competition is a motivation because we don't think the new indication will delay the date when generic versions of Velcade can begin to be sold in the U.S..
One thing that did strike us as a bit odd is that the news of the new FDA approval was announced on a Friday evening in the midst of the August holiday season. We're not sure how to interpret that.
In any case, we wouldn't read too much "general" into this news. It is, we suspect, something specific to Velcade and the particular competitive pressures it is feeling.
Hope this helps shed a bit of light on the situation. Thanks for your comments.
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• Page 1 of 1
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