Impress Study
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
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biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Impress Study
The Impress study top line data release has been extended by a little over a year to Feb 2025. As I recall the end point was ORR. We know enrollment was at 50% in November. Be nice to have some clarification here. Patients enrolled in this study were left with few options. Why wait another year to report top line?
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biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: Impress Study
Off-Label Uses Once Imetelstat is Approved
I would ask you to expand your view point beyond approval in june (really hope this is the case) basically pps focus for June date could be not quite the best focus. --- from Zhears
As I understand it, once Imetelstat gets approved (depending on ODAC recommendations from March 14th meeting) many off-label uses are possible and I would say likely considering the MOA --- two methods of killing cancer stem cells -- as a supplement to chemo and in various combinations. It seems to me that patients in need and their doctors would want all possible speed for treatment.
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I would ask you to expand your view point beyond approval in june (really hope this is the case) basically pps focus for June date could be not quite the best focus. --- from Zhears
As I understand it, once Imetelstat gets approved (depending on ODAC recommendations from March 14th meeting) many off-label uses are possible and I would say likely considering the MOA --- two methods of killing cancer stem cells -- as a supplement to chemo and in various combinations. It seems to me that patients in need and their doctors would want all possible speed for treatment.
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Previous:
by LWS » Wed Dec 06, 2023
Off-label uses
If I understand correctly, the concept of off-label uses offers a great deal of flexibility, once a medicine is NDA approved. A decision can be made between the patient and his doctor. If that is so, Imetelstat, once approved, will be used in many blood cancer situations and in combinations with other approved medicines. The most obvious is the TELOMERE combination (AML---with AbbVie) which has shown outstanding synergies in preclinical testing.
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bp --- I agree with you that, based upon available data and trials, Imetelstat deserved both a "priority review" and "expanded access" (EAP). I can see why the FDA oncology advisory committee (ADCOM) would want some extra time "standard review" to make sure nothing has been missed, since Imetelstat is a game-changer and the NDA approval will open other doors and off-label clinical use. I suspect that KOL and patient interviews will be overwhelmingly positive. Hopefully, that will lead to a shorter timeline.
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huntingonthebluffs
- Posts: 250
- Joined: Wed Feb 24, 2016 12:00 am
Re: Impress Study
Based on our experience, I would never under estimate the number of monkey wrenches the FDA is so blatantly willing to use to delay approval or continue to maintain its all out assault on any CT using Imetelstat.
However, were we ever specifically/exactly certain what all the FDA was looking for out of IMPRESS to allow TELOMERE to proceed? I always thought dosing was a weak reason to delay given the years of CT dosing experience in the books.
But if we were certain, could the delay/extension possibly be in anyway related to the newly discovered ferroptosis MOA?
If we weren't certain, could the delay/extension be related to the complexity of definitive dosing of HR MDS/AML with the moving/shifting target of the diseases mutations?
Again all of the above seems to be marginal rational at best. So my bet is still on the FDA's playbook just throwing out more of the same ol' bs. While everyone involved is too compromised or unwilling to risk a challenge to the obvious abuse of power. Pretty simple actually IMHO.
However, were we ever specifically/exactly certain what all the FDA was looking for out of IMPRESS to allow TELOMERE to proceed? I always thought dosing was a weak reason to delay given the years of CT dosing experience in the books.
But if we were certain, could the delay/extension possibly be in anyway related to the newly discovered ferroptosis MOA?
If we weren't certain, could the delay/extension be related to the complexity of definitive dosing of HR MDS/AML with the moving/shifting target of the diseases mutations?
Again all of the above seems to be marginal rational at best. So my bet is still on the FDA's playbook just throwing out more of the same ol' bs. While everyone involved is too compromised or unwilling to risk a challenge to the obvious abuse of power. Pretty simple actually IMHO.