Cindy Chmielewski (or on twitter @MyelomaTeacher) does not give up easily. She is a Myeloma Patient Advocate and works tirelessly to provide assistance to the myeloma patient community. She was at the FDA advisory meeting which was to provide a nonbinding recommendation on the approval of Selinexor for end stage myeloma patients who have exhausted all available drugs. She and all myeloma patients, advocates,and myeloma specialists had recommended the FDA give these patients the opportunity to have access to the drug. I believe the draft document which was reviewed was quite negative, but all of the questions raised were answered by the myeloma patients, myeloma specialists, and advocates to their satisfaction. Selinexor has been given positive feedback by myeloma specialists almost universally, so the fact the approval was delayed for at least 2 years was heartbreaking. One interesting comment on twitter by the Patient Advocate Yelak Biru stated, "there is precedence where the FDA has approved Panobinistat despite negative vote from the independent ODAC committee. There may be a potential for them to do that as these cohort of patients really need an option." Cindy wrote the following request, and I will write the FDA, and pass it on to all of you to do the same. The panel was influenced because the drug can be used on a compassionate use basis, but the myeloma specialists made clear the 85% of patients being treated at community hematologists would not recieve Selinexor due to the lack of available necessary resources at community practices. Together we can SAVE LIFE!
Cindy Chmielewski
To:Myeloma community
Mar 6 at 10:02 AM
Hello My Friends,
Many of you were also disappointed in the outcome of the ODAC meeting on Selinexor. There is still time to voice your concern.
Below are the email and phone contact details for Ann Farrell and Nicole Gormley, who are leaders at FDA responsible for Hematology/Oncology drug approvals at FDA, should you or other advocates decide you would like to reach out. Feel free to share this with others.
Contact Information
Richard Pazdur, MD
Director, Oncology Center of Excellence
Acting Director Office of Hematology Oncology Products
301-796-2340
[email protected]
Ann Farrell, MD
Director, Division Hematology Oncology Drug Products
301-796-1352
[email protected]
Nicole Gormley
Cross-Disciplinary Team Leader and Supervisory Physician
240-402-0210
[email protected]
Thanks,
Cindy
Thank You Cindy and Yelak. Selinexor is a new class of drugs, and each new class of drugs has increased myeloma life expectancy by 20 to 25% from 3 years to nearly 6 years. The letter I emailed is below. Please feel free to use any part or all of it. We can make a difference.
Gary Petersen <[email protected]>
To:[email protected],[email protected],[email protected]
Cc:Jenny Ahlstrom,Cynthia Chmielewski,Fonseca, Rafael, M.D.,Richardson, Paul G.,M.D.,Saad Z. Usmani
Mar 7 at 10:12 AM
Myeloma patients who are at the end stage of the disease have NO current options other than clinical trials or if available' compassionate use. These options are only available at the larger academic centers and they treat just 15% of the total of all myeloma patients. The remaining 85% are treated in the community oncology setting. At the FDA's Oncology Drugs Advisory Committee (ODAC), the Myeloma Specialists at the meeting explained the lack of infrastructure at the community oncologist makes managing the compassionate use unlikely for the vast majority of end stage patients. Patients who get to the penta refractory end stage disease have shown an undeterred commitment to hanging on for the next treatment or cure. Clinical Trials like CAR T, ADC, and BiTE take time to enroll and are under great demand. Unfortunately patients are waiting and "Dying to get in!" The real deal is some of the patients with end stage myeloma were MRD negative after Selinexor, they won the myeloma lottery.
I am the [email protected] and have followed this trial with the same excitement exhibited by the best Myeloma Specialists in the world. All the advocates, myeloma specialists, and patients I have talked to are despondent that your vote could be so different from that of the best myeloma specialists in the world. I think that experience, expertise, and understanding of myeloma experts was grossly underrepresented on the panel. If just two more myeloma specialists were on the panel, I believe the vote would have been 7 to 6 for expedited approval.
Jenny Ahstrom, the founder of http://www.MyelomaCrowd.org has written an objective review of the meeting and the frustration of the entire myeloma community, and you can view it at the link:
FDA Denies Early Access to Selinexor/Dex in Multiple Myeloma - The Myelo...FDA halts early access to selinexor/dex approval at briefing meeting. We need significant change in order to ide...
Please reconsider the value of all the myeloma experience represented by the myeloma specialists, myeloma advocates, patients, and caregivers who have all lived this disease and watch their patients, friends and family members die too soon. I PRAY you will please help us SAVE LIFE!
Cindy Chmielewski
To:Myeloma community
Mar 6 at 10:02 AM
Hello My Friends,
Many of you were also disappointed in the outcome of the ODAC meeting on Selinexor. There is still time to voice your concern.
Below are the email and phone contact details for Ann Farrell and Nicole Gormley, who are leaders at FDA responsible for Hematology/Oncology drug approvals at FDA, should you or other advocates decide you would like to reach out. Feel free to share this with others.
Contact Information
Richard Pazdur, MD
Director, Oncology Center of Excellence
Acting Director Office of Hematology Oncology Products
301-796-2340
[email protected]
Ann Farrell, MD
Director, Division Hematology Oncology Drug Products
301-796-1352
[email protected]
Nicole Gormley
Cross-Disciplinary Team Leader and Supervisory Physician
240-402-0210
[email protected]
Thanks,
Cindy
Thank You Cindy and Yelak. Selinexor is a new class of drugs, and each new class of drugs has increased myeloma life expectancy by 20 to 25% from 3 years to nearly 6 years. The letter I emailed is below. Please feel free to use any part or all of it. We can make a difference.
Gary Petersen <[email protected]>
To:[email protected],[email protected],[email protected]
Cc:Jenny Ahlstrom,Cynthia Chmielewski,Fonseca, Rafael, M.D.,Richardson, Paul G.,M.D.,Saad Z. Usmani
Mar 7 at 10:12 AM
Myeloma patients who are at the end stage of the disease have NO current options other than clinical trials or if available' compassionate use. These options are only available at the larger academic centers and they treat just 15% of the total of all myeloma patients. The remaining 85% are treated in the community oncology setting. At the FDA's Oncology Drugs Advisory Committee (ODAC), the Myeloma Specialists at the meeting explained the lack of infrastructure at the community oncologist makes managing the compassionate use unlikely for the vast majority of end stage patients. Patients who get to the penta refractory end stage disease have shown an undeterred commitment to hanging on for the next treatment or cure. Clinical Trials like CAR T, ADC, and BiTE take time to enroll and are under great demand. Unfortunately patients are waiting and "Dying to get in!" The real deal is some of the patients with end stage myeloma were MRD negative after Selinexor, they won the myeloma lottery.
I am the [email protected] and have followed this trial with the same excitement exhibited by the best Myeloma Specialists in the world. All the advocates, myeloma specialists, and patients I have talked to are despondent that your vote could be so different from that of the best myeloma specialists in the world. I think that experience, expertise, and understanding of myeloma experts was grossly underrepresented on the panel. If just two more myeloma specialists were on the panel, I believe the vote would have been 7 to 6 for expedited approval.
Jenny Ahstrom, the founder of http://www.MyelomaCrowd.org has written an objective review of the meeting and the frustration of the entire myeloma community, and you can view it at the link:
FDA Denies Early Access to Selinexor/Dex in Multiple Myeloma - The Myelo...FDA halts early access to selinexor/dex approval at briefing meeting. We need significant change in order to ide...
Please reconsider the value of all the myeloma experience represented by the myeloma specialists, myeloma advocates, patients, and caregivers who have all lived this disease and watch their patients, friends and family members die too soon. I PRAY you will please help us SAVE LIFE!
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