ODAC unanimously votes in favor of using #MRD as an early endpoint for accelerated approval in #myeloma trials

This was a huge team effort for more than 8 years and with the generosity of unprecedented data sharing from many investigators around the world. Thank you all!
#mmsm

My comments at the FDA ODAC on MRD as an accelerated approval endpoint in Myeloma

Safety is the big reason this is a bad decision

Impact of bridging therapy with Ide-cel for myeloma:U.S. Myeloma Immunotherapy Consortium. Blood Cancer Journal. Key takeaway: 'Less is more'; exercise caution with intensified/infusional Cy, if feasible. #myeloma #CAR -T
shorturl.at/eqyZ5

My final PhD paper is out in Nature Immunology! 🥳

We previously identified inflammatory stroma in the #myeloma marrow🦴

But what is it doing there?

Here, we show it conspires with the most abundant marrow cell for long-term tumor support: the neutrophil!

rdcu.be/dEkPk

🗞️“Today the FDA Oncology Drugs Advisory Committee voted 12-0 in favor of using minimal residual disease as an accelerated approval endpoint in myeloma trials.”

💡Next: #ctDNA MRD➖ as an endpoint for #ColorectalCancer .

Time to reconsider.
ctDNA➕📉DFS
ctDNA➖📈DFS

OncoAlert

ODAC approves MRD as surrogate end point for myeloma trials .
12 vs zero . Not a single vote against it . Is the corelation between MRD and OS good enough at trial level to get accelerated approvals ? Will this open gateway for MRD as end point for solid tumors? I hope not.…

T.C. Burdur Şiş Kültür Elçisi X Molecular mechanism of burdur şiş in multiple myeloma makalem çok yakında sizlerle artık tıpta da yeri olacak

Great victory in myeloma today: ODAC voted 12-0 for MRD as early endpoint for accelerated approval in myeloma

Honored to present EVIDENCE meta-analysis, work I pioneered 15 yrs ago. Congrats also to I2TEAMM

⁦International Myeloma Foundation⁩ ⁦Multiple Myeloma RF⁩ #mmsm ⁦HealthTree Foundation⁩ #myeloma

Look at all that hair 🙌🏼🙌🏼 5 months of growth…it really fills my heart ♥️
#myeloma #hairloss #cancer #stemcelltransplant

🫘Renal involvement in haematological malignancies

🦀Most common in Multiple Myeloma and Lymphomas

1️⃣Direct renal infiltration in lymphomas/leukemias

2️⃣Paraneoplastic-MCD in Hodgkin lymphoma/ MPGN in CLL

3️⃣Treatment related-Tumor lysis syndrome/TMA/Nephrotoxic chemo…

Today the FDA Oncologic Drugs Advisory Committee voted 12-0 in favor of using minimal residual disease as an accelerated approval endpoint in multiple myeloma clinical trials.
Meeting info: fda.gov/advisory-commi…
Watch: youtube.com/watch?v=pooME9…

#FDAODAC

Welllllll it’s been a busy busy 24 hours in the world of #myeloma ! 👀

Incredible progress! Congrats to the cilta-cel team!

#oncopharm

Now… excuse me while I go update some slides! 🤦🏻‍♀️

Celebrating Myeloma, a beautiful womxn with both passing & chair privilege.

Let a Trans person touch you & your family today, we will eventually all come together!

#TransWomenAreWomen
#TransRightsAreHumanRights #TransIsBeautiful #LGBTQ 🏳️‍⚧️

Should MRD negativity be accepted as a surrogate endpoint for clinical trials in myeloma?
What should be part of the FDA discussion tomorrow about MRD? #mmsm #mmMRD 🧵

BREAKING: U.S. FDA’s ODAC Recognizes MRD as an Accepted End Point for Accelerated Approval in Multiple Myeloma #mmsm #oncology onclive.com/view/fda-s-oda…

FDA ODAC voted 12 - 0 in favor of MRD as a new clinical endpoint for accelerated approval in multiple myeloma clinical trials! Great news for our patients #mmsm Congratulations to everybody involved! Especially C. Ola Landgren, M.D. Bruno Paiva

🚨ODAC voted to Approve MRD as an surrogate endpoint for Myeloma trials
Yes:12
No: 0
#mmsm #myeloma #MedEd #USMRC USMIRC News FDA Oncology OncoAlert

Huge win for #myeloma patients today! The ODAC committee approved MRD testing as an early endpoint for MM drugs in trials. This accelerates progress towards new treatments! Thank you all who participated Nikhil C. Munshi, MD C. Ola Landgren, M.D. International Myeloma Foundation + #mmsm myeloma.org/news-events/mu…

Blood cancer disrupts healthy blood cell production. It starts in the bone marrow or lymph system. Leukemia, lymphoma, and myeloma are the main types. They cause abnormal cell growth, hindering infection fight and bleeding control.
#FightBloodCancer