Mohamad Mohty @Mohty_EBMT
Professor and head of Hematology Sorbonne Univ.; past-president of the EBMT; Chairman of the IACH; Editor in Chief: Bone Marrow Transplant; Clin Hematol Int. clinical-hematology.org Joined June 2014-
Tweets37K
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📢Our latest @TheIACH post @TheEBMT webinar 📽️Now available on demand! Watch the full webinar for FREE 👇👇 clinical-hematology.org/post-congress-… @BipinSavani @Florent_Malard @nagler_EBMT @Mohty_EBMT
Please join us to celebrate the 10th anniversary of the @COMyCongress Thank Dr T Facon for your leadership and for your contributions to the hematology field. @EHA_Hematology @TheIACH @TheEBMT @Hematologie_JLE vimeo.com/940826756/9d4e…
We look forward to welcoming you to the ⭐10th COMy Congress⭐ 📅 May 23-26, 2024 🗼 Paris, France & Online a welcome note by Prof. Thierry Facon Register TODAY and save your spot 👇 bit.ly/3ZSb31v @Mohty_EBMT @nagler_EBMT @mvmateos
📢Join us for the upcoming Joint IACRLRD/IACH Webinar: PML, an unexpected hub of leukemia cures 🗓️May 2 2024 ⏲️6PM CET, 12PM NY Register for FREE🔽 bit.ly/3xWd3fv @Mohty_EBMT #IACRLRD
Join us for the upcoming @TheIACH post @TheEBMT in French 🗓️May 2 2024 ⏲️7PM CET, 1PM NY Register for FREE🔽 bit.ly/44nw3j3 with Frederic Baron, Edouard Forcade,Michael Loschi, @Florent_Malard @zina_peric @AnnalisaRugger1 @Mohty_EBMT
IACH News of the Week 28.4.2024 New bulletin: @TheIACH @Mohty_EBMT clinical-hematology.org/news-of-the-we…
Combining CAR-T cells and allo-transplant: what a fascinating approach! @NEJM @TheIACH @TheEBMT @Florent_Malard @RemyDulery
Another week, another podcast!🎉 This week, hear from @Mohty_EBMT, Ernst Holler & @Florent_Malard, who discuss novel agents in acute/chronic #GvHD, the role of the gut microbiome & how this can be manipulated: 👉 ow.ly/Yjip50RoVv7 @TheEBMT #BMTsm #HemOnc
10) Finally the route to accelerated approval requires expertise and experience in a given disease and the risks and benefits of interventions and the endpoints. It requires collaboration of regulators, Pharma, investigators, patients, and patient organizations.
9) Disease matters. Extrapolating failures from various hard to treat cancers where response often doesn’t equate clinical benefit (either because the measurement is flawed or the benefit achievable with our current understanding is small) to all cancers is a fallacy.
8) Accelerated approval thus balances the benefit of having access to effective drugs early versus the risks of incorrectly approving a useless or harmful drug. Done right, in a disease like myeloma with reliable biomarkers, accelerated approval saves a large number of lives.
8) Accelerated approval thus balances the benefit of having access to effective drugs early versus the risks of incorrectly approving a useless or harmful drug. Done right, in a disease like myeloma with reliable biomarkers, accelerated approval saves a large number of lives.
7) Important: The purpose of accelerated approval is to help patients. That is our one and only goal. We do not want a net loss of lives because we are focused on being text book perfect. It’s a risk benefit judgment call.
6) Important: If a drug approved is priced exorbitantly it doesn’t mean the whole accelerated approval pathway is at fault. It means we have to separately reform the way drug prices in the US are set to be proportional to the added value they provide. It is a concern.
5) Important: If a confirmatory trial is not done in a timely manner that doesn’t mean the accelerated approval pathway is wrong. It means either regulators for a good reason have allowed a delay (or lack) of such a trial; or lacking such a reason it means they need to enforce
4) Important: If a confirmatory trial is negative that doesn’t mean the whole accelerated approval pathway is at fault. A small proportion of confirmatory trials will be negative — that means we have followed the principles of accelerated approval (see second tweet in thread).
3) Accelerated approval is predicated on confirmatory trials being done in a timely manner. Failure to do so should usually result in withdrawal of the accelerated approval. The FDA is currently being quite strict on this aspect.
2) The mechanism is not meant to be 100% fool proof because with such a high bar sensitivity will be low and many truly active drugs will be rejected incorrectly or greatly delayed. But it needs to be as rigorous as is reasonable so we don’t approve too many ineffective drugs.
On Accelerated Approval 1) In life threatening diseases like cancer the rapid approval of promising new drugs based on phase II data and/or surrogate endpoints is reasonable because waiting for full approval may result in more lives lost due to delay in approval of active drugs.
Vincent Rajkumar @VincentRK
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Blood Journal @BloodJournal
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ASH @ASH_hematology
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chadi nabhan MD, MBA,.. @chadinabhan
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yo cruce la frontera @yocrucelafronte
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Mehdi Hamadani, MD @MediHumdani
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chadi nabhan MD, MBA,.. @chadinabhan
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380 Followers 185 Following Peds BMT/Hem 🩸focused on Inborn Errors of Immunity 🧬 Member of the @Lasidimmuno Junior Committee and @TheEBMT_Trainee
Mercedes Montoro @mercedesmontoro
498 Followers 649 Following MSc, RN. Hospital Clínic de Barcelona. Caring for patients undergoing CAR-T Cell Therapy.Please join us to celebrate the 10th anniversary of the @COMyCongress Thank Dr T Facon for your leadership and for your contributions to the hematology field. @EHA_Hematology @TheIACH @TheEBMT @Hematologie_JLE vimeo.com/940826756/9d4e…
📢Our latest @TheIACH post @TheEBMT webinar 📽️Now available on demand! Watch the full webinar for FREE 👇👇 clinical-hematology.org/post-congress-… @BipinSavani @Florent_Malard @nagler_EBMT @Mohty_EBMT
We look forward to welcoming you to the ⭐10th COMy Congress⭐ 📅 May 23-26, 2024 🗼 Paris, France & Online a welcome note by Prof. Thierry Facon Register TODAY and save your spot 👇 bit.ly/3ZSb31v @Mohty_EBMT @nagler_EBMT @mvmateos
📢Join us for the upcoming Joint IACRLRD/IACH Webinar: PML, an unexpected hub of leukemia cures 🗓️May 2 2024 ⏲️6PM CET, 12PM NY Register for FREE🔽 bit.ly/3xWd3fv @Mohty_EBMT #IACRLRD
Join us for the upcoming @TheIACH post @TheEBMT in French 🗓️May 2 2024 ⏲️7PM CET, 1PM NY Register for FREE🔽 bit.ly/44nw3j3 with Frederic Baron, Edouard Forcade,Michael Loschi, @Florent_Malard @zina_peric @AnnalisaRugger1 @Mohty_EBMT
IACH News of the Week 28.4.2024 New bulletin: @TheIACH @Mohty_EBMT clinical-hematology.org/news-of-the-we…
Thank you Georgetown, BCM and GTC for such an amazing 2 days !! Our speakers were impressive !! Fellows, residents and students, no doubts, they will be a unique generation of leukemia and transplant doctors.Thank you Christina, Lacey, Jennifer, Jeff, Anne, Maher, Byron!
Reinforced 100-fold why I am interested in Myeloid Malignancies and Cell Therapy
Thank you Georgetown, BCM and GTC for such an amazing 2 days !! Our speakers were impressive !! Fellows, residents and students, no doubts, they will be a unique generation of leukemia and transplant doctors.Thank you Christina, Lacey, Jennifer, Jeff, Anne, Maher, Byron!
@MycalCasey @Mohty_EBMT It was pretty amazing lecture !!!!
“Transplanters are artist” -@Mohty_EBMT Exciting and informative lecture! @BcmHem
Parfois, la vie de cabinet vous offre les plus belles rencontres professionnelles et personnelles. Magnifique réunion de la grande famille du ministère de la santé autour du meilleur d'entre nous, @emerygreg, décoré par @agnesbuzyn.
MRD talk by Ken Anderson.
Dr. Ken Anderson commenting on ODAC vote to recommend MRD as surrogate endpoint for accelerated approval for myeloma. @szusmani @NikhilMunshiMD @DanaFarber @SagarLonialMD
There are times when all your tests are normal but there’s still something wrong. Because there are things about health and humans we still don’t know or understand. Turns out medicine is imperfect. Just like people.
@GvHD_Meade In essentially EVERY trial that has randomized Auto to no Auto following intensive induction therapy for MM, AutoSCT has been associated with prolonged PFS. If the Myeloma docs are not willing to accept PFS as a valid endpoint in BMT trials, they shouldn't in CAR-T studies
@Mohty_EBMT @NEJM @TheIACH @TheEBMT @Florent_Malard @RemyDulery Yes, the dream might be coming true.
Combining CAR-T cells and allo-transplant: what a fascinating approach! @NEJM @TheIACH @TheEBMT @Florent_Malard @RemyDulery
Another week, another podcast!🎉 This week, hear from @Mohty_EBMT, Ernst Holler & @Florent_Malard, who discuss novel agents in acute/chronic #GvHD, the role of the gut microbiome & how this can be manipulated: 👉 ow.ly/Yjip50RoVv7 @TheEBMT #BMTsm #HemOnc
Our editorial on drug waste from discarded chemotherapeutic agents: can we really save money by limiting waste? When the Problem and the Solution Are More Than Meets the Eye. @MayoProceedings @MayoMyeloma @MayoCancerCare #OpenAccess mayoclinicproceedings.org/article/S0025-…
10) Finally the route to accelerated approval requires expertise and experience in a given disease and the risks and benefits of interventions and the endpoints. It requires collaboration of regulators, Pharma, investigators, patients, and patient organizations.
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