ADCOM
Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Re: ADCOM
About FDA Advisory Committees
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.
UPCOMING ADVISORY COMMITTEE MEETINGS
November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
FDA's advisory committees are established to provide functions which support the agency's mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services. Each committee is subject to renewal at two-year intervals ---
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.
UPCOMING ADVISORY COMMITTEE MEETINGS
November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
FDA's advisory committees are established to provide functions which support the agency's mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services. Each committee is subject to renewal at two-year intervals ---
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
LWS until the agenda says Geron, it ain’t happening.
Re: ADCOM
bp --- If we only consider Imetelstat's successes (scientific and medical), Imetelstat appears to be a "sure-thing" for approvals on many levels in many ways. We are all now focusing on the ADCOM (with reference to Geron) and a "full court press" (with reference to KOLs, conferences, publications, etc.).
=================================
=================================
Previous:
Obviously, it is an overwhelming combination of “conclusive evidence”:
1/ The successful phase 3 trials
2/ The conferences (EHA, ASCO leading to ASH2023)
3/ The experts (KOLs, Webinars, MD Anderson, etc.)
4/ Transfusion independence, survival time, safety, uniqueness, fatigue factor
5/ Fast track, orphan drug status, EAP
6/ Disease modification, kills cancer stem cells
7/ Combination potential and synergies
8/ Patients’ immediate and unmet needs
9/ The medical journals (Lancet and others)
10/ NDA submitted, accepted and near approval (timeline flexible)
The ADCOM and the FDA will not ignore the obvious.
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
LWS, the lesson has been taught many times over, there is no sure thing with Geron. I would caution you not to think in terms of absolutes. We have no idea what is in the heads of the FDA officials. We do know they did not think enough of Imetelstat to grant priority review. That fact alone is worthy of reflection.
Re: ADCOM
bp--- Of course there are no "sure-things" when considering Geron and John Scarlett (as a business). Imetelstat's "overwhelming evidence" as a tested medicine logically leads to a "very-high-probability of success" for the NDA approval (in my opinion). In addition, (IMO), the EAP is an informal approval that is now operational, giving the ADCOM time to get "its act together".
I don't believe rejection of Imetelstat is possible, but we live in a strange and cruel world.
I don't believe rejection of Imetelstat is possible, but we live in a strange and cruel world.
Re: ADCOM
So far, Imetelstat is not on the agenda as of Oct.12. This material may be of interest to anyone that wants to know more about the workings of the ADCOM for Oncology and the FDA. Of course Geron knows this and is actively working with this committee (seems to meet every month or so).
===================================================================
Date:
November 16, 2023
Time:
9:00 AM - 1:30 PM ET
Location: All meeting participants will be joining this advisory committee meeting via an online teleconferencing and/or video conferencing platform.
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). Confirmatory trials are postmarketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.
The two products to be discussed are: (1) FOLOTYN (pralatrexate), NDA 022468 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), and (2) BELEODAQ (belinostat), NDA 206256 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory PTCL. Based on the updates provided, the Committee will have a general discussion about delayed confirmatory trials as well as a focused discussion on next steps for the two products, FOLOTYN (pralatrexate) and BELEODAQ (belinostat), approved for PTCL. The overall goal will be the continued optimization of the accelerated approval process with a focus on decreasing the amount of time to verify (or fail to verify) clinical benefit, while continuing to provide early availability of promising oncology products.
Meeting Materials
FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-3329. Please note that late, untimely filed comments will not be considered. The docket will close on November 15, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 15, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Comments received on or before November 1, 2023 will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
===================================================================
Date:
November 16, 2023
Time:
9:00 AM - 1:30 PM ET
Location: All meeting participants will be joining this advisory committee meeting via an online teleconferencing and/or video conferencing platform.
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). Confirmatory trials are postmarketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.
The two products to be discussed are: (1) FOLOTYN (pralatrexate), NDA 022468 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), and (2) BELEODAQ (belinostat), NDA 206256 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory PTCL. Based on the updates provided, the Committee will have a general discussion about delayed confirmatory trials as well as a focused discussion on next steps for the two products, FOLOTYN (pralatrexate) and BELEODAQ (belinostat), approved for PTCL. The overall goal will be the continued optimization of the accelerated approval process with a focus on decreasing the amount of time to verify (or fail to verify) clinical benefit, while continuing to provide early availability of promising oncology products.
Meeting Materials
FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-3329. Please note that late, untimely filed comments will not be considered. The docket will close on November 15, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 15, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Comments received on or before November 1, 2023 will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
Re: ADCOM
Remember, Imetelstat is now available to everyone who needs it and wants it now (EAP--Extended Access Program). This is better than a "priority review" while the NDA goes through the FDA advisory committee review (ADCOM) at their leisure. The markets have misinterpreted the importance and the significance of the EAP. This is an informal approval of Imetelstat (here and now), that is viable until the NDA gets approved (formal approval).
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
Lewis, this is very likely not a true statement and you should verify if you think it is. Who do you think is paying for Imetelstat for “anyone who needs it?”. I don’t think Geron is giving it away and I don’t know if insurance is providing coverage, do you? Geron is not a philanthropic organization. The delay in approval of an extra four months is a big burden placed on a small company. This is not better as you suggest than priority review.
Re: ADCOM
========================================================================From bp ---Lewis, this is very likely not a true statement and you should verify if you think it is. Who do you think is paying for Imetelstat for “anyone who needs it?”
bp --- You are asking two different questions.
1/ Is an EAP (Extended Access Program) in place for Imetelstat?
As far as I can tell, it is. Imetelstat is available and presumably being used in accordance with the rules of this preapproval (before NDA approval) program.
2/ Who is paying for it?
I suspect insurance claims, at this point in time, are being rejected. There are likely those, with sufficient assets, that are paying out of their own pockets (similar to Wegovy for weight loss). I don't have any information about benevolent or charitable contributions from Geron or anyone else, but they may exist.
Here are some possibilities:
AMERICAN CANCER SOCIETY: (800) 227-2345
The American Cancer Society has numerous support programs for
patients and families including 30 Hope Lodges located throughout
the U.S. that offer a free place to stay during treatment and the
Road to Recovery Program which connects patients to volunteers
who provide free rides to medical appointments.
http://www.cancer.org
ASSISTANCE FUND: (855) 845-3663
Provides financial support to chronically ill patients with highcost medications.
https://enroll.tafcares.org
BONE MARROW & CANCER FOUNDATION: (800) 365-1336
Provides coverage for many costs associated with bone marrow
transplant. Grants are limited to specific institutions, so speak to a
hospital social worker or call BMCF for more information.
www.bonemarrow.org
=================================================================
Wegovy-maker Novo Nordisk raises outlook as sales of its weight-loss drug soar
Re: ADCOM
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.
=================================
Previous (for reference):
FOSTER CITY, Calif., June 29, 2023--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor. As allowed under the U.S. Food and Drug Administration (FDA) policies, companies may offer an EAP, which permits an investigational medicinal product intended to treat a serious or life-threatening condition, such as lower risk myelodysplastic syndromes (MDS), to be used outside of a clinical trial.1
"We have heard physicians in both academic and community settings express the need for new treatment options for their lower risk MDS patients, and they will now have an option to access imetelstat through the EAP," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "With positive IMerge Phase 3 results submitted to the FDA, we now plan to be working with clinicians, patients and the MDS patient advocacy community to provide access to imetelstat for eligible patients through our EAP that was accepted by the FDA."
=================================
Previous (for reference):
FOSTER CITY, Calif., June 29, 2023--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor. As allowed under the U.S. Food and Drug Administration (FDA) policies, companies may offer an EAP, which permits an investigational medicinal product intended to treat a serious or life-threatening condition, such as lower risk myelodysplastic syndromes (MDS), to be used outside of a clinical trial.1
"We have heard physicians in both academic and community settings express the need for new treatment options for their lower risk MDS patients, and they will now have an option to access imetelstat through the EAP," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "With positive IMerge Phase 3 results submitted to the FDA, we now plan to be working with clinicians, patients and the MDS patient advocacy community to provide access to imetelstat for eligible patients through our EAP that was accepted by the FDA."
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
I don’t think they want more time to review. They have had plenty. I just think they are a top heavy institution (18,000 employees), that can’t get out of its own way.
Re: ADCOM
Oncology ADCOM
All eyes are now focusing on the Oncology ADCOM and the longer timeline (standard review). Can that timeline be shortened by overwhelming positive testimony by the KOLs and patients?
Imetelstat, as far as I can tell, is not on the agenda for Nov. 16. Hopefully, it will show up at their next meeting. It appears that anyone that is sufficently interested can get involved. I would hope, if there is a way, that some on this board would participate.
====================================
Next meeting of ADCOM (oncology) Nov. 16, 2023 -- excerpt
All eyes are now focusing on the Oncology ADCOM and the longer timeline (standard review). Can that timeline be shortened by overwhelming positive testimony by the KOLs and patients?
Imetelstat, as far as I can tell, is not on the agenda for Nov. 16. Hopefully, it will show up at their next meeting. It appears that anyone that is sufficently interested can get involved. I would hope, if there is a way, that some on this board would participate.
====================================
Next meeting of ADCOM (oncology) Nov. 16, 2023 -- excerpt
Location: All meeting participants will be joining this advisory committee meeting via an online teleconferencing and/or video conferencing platform.
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). Confirmatory trials are postmarketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.
.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-3329. Please note that late, untimely filed comments will not be considered. The docket will close on November 15, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 15, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Re: ADCOM
ADCOM (FDA advisory oncology committee) hearings for Imetelstat will be open to and available to the public. No more guessing about what is being said to them by experts, KOLs, patients and other interested parties. The truth will prevail. Imetelstat is in a class by itself for blood cancer treatments and is needed now. The EAP also is in place and functioning for current patients.
=================================================================
Previous (for reference):
=================================================================
Previous (for reference):
Obviously, it is an overwhelming combination of “conclusive evidence”:
1/ The successful phase 3 trials
2/ The conferences (EHA, ASCO leading to ASH2023)
3/ The experts (KOLs, Webinars, MD Anderson, etc.)
4/ Transfusion independence, survival time, safety, uniqueness, fatigue factor
5/ Fast track, orphan drug status, EAP
6/ Disease modification, kills cancer stem cells
7/ Combination potential and synergies
8/ Patients’ immediate and unmet needs
9/ The medical journals (Lancet and others)
10/ NDA submitted, accepted and near approval (timeline flexible)
The ADCOM and the FDA will not ignore the obvious.
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
As noted, Imetelstat is not on the ADCOM agenda for Nov 16th.
Re: ADCOM
bp--- The history of this Oncology ADCOM would suggest that the next meeting (after Nov. 16) would be sometime in December, 2023. The timeline for Imetelstat NDA approval is getting to all of us. As you say, there is no such thing as a "sure-thing" but, considering everything, I cannot conceive of Imetelstat being rejected. The positives are established and well known. The negatives (from medical experts and KOLs) do not seem to exist.
=================================
History of Oncology ADCOM meetings:
=================================
History of Oncology ADCOM meetings:
November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee
• November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee
• October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
October 4, 2023: Meeting of the Oncologic Drugs Advisory Committee
• October 4, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
June 16, 2023: Meeting of the Oncologic Drugs Advisory Committee
• June 16, 2023: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement
April 28, 2023: Meeting of the Oncologic Drugs Advisory Committee
• April 28, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
March 9, 2023: Meeting of the Oncologic Drugs Advisory Committee
• March 9, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
February 9, 2023: Meeting of the Oncologic Drugs Advisory Committee
• February 9, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: ADCOM
I would never recommend thinking in absolutes re Geron. You may not consider the failure of FDA to approve. I could not conceive of Janssen rejecting a Geron partnership. Now I no longer think in terms of absolutes. I highly recommend it.
Re: ADCOM
Bp - Totally agree on all points.
What has been an absolute this past year, is that while the SP has taken a haircut to the tune of about 50%, our CEO has increased his salary by 20+%.....not to mention all of those bonus shares for doing his job. At least someone is doing well with Geron these days. -Kmall
What has been an absolute this past year, is that while the SP has taken a haircut to the tune of about 50%, our CEO has increased his salary by 20+%.....not to mention all of those bonus shares for doing his job. At least someone is doing well with Geron these days. -Kmall
Re: ADCOM
bp & kmall --- I never have thought in "absolutes". Also, I never thought we would be in WW3 (China, Russia, Iran, others), but we seem to be there. As I stated, there seems to be no important negatives (that I am aware of) from medical experts or KOLs concerning Imetelstat (please correct, if wrong).
The world has gone insane (House of Representatives, as an example). I don't believe that insanity applies to the FDA, but that is always a possibility. In my opinion, Imetelstat's NDA will be approved, especially with the EAP already in place. Imetelstat needs to get on the ADCOM agenda post-haste. That should not be a problem, but who knows. The timeline is way too long now.
John Scarlett is a separate story. He has been considered everything from a visionary to a fraud.
The world has gone insane (House of Representatives, as an example). I don't believe that insanity applies to the FDA, but that is always a possibility. In my opinion, Imetelstat's NDA will be approved, especially with the EAP already in place. Imetelstat needs to get on the ADCOM agenda post-haste. That should not be a problem, but who knows. The timeline is way too long now.
John Scarlett is a separate story. He has been considered everything from a visionary to a fraud.