Top Tweets for #Ziftomenib
Ziftomenib demonstrates potent activity against a subset of the drug-induced MEN1 mutations found in patients with acute myeloid leukemia. Read the study in Blood: https://t.co/88oe07r0ra #AML #Ziftomenib #BloodJournal
A packed hall before our presentations in #EHA2026 on novel #AMLsm therapies where I am opening the session with our #KOMET007 study combination of #Ziftomenib with 7+3 & later my @YaleCancer colleague Nikolai Podoltsev will present Ph1 of Tuspetinib with aza-ven @YaleHematology
Excited to be heading to #EHA2026 and to open the oral presentations session for novel #AMLsm therapies with an exciting update on #KOMET007 study combination of #Ziftomenib with 7+3 which then will be closed by my @YaleCancer colleague Nikolai Podoltsev presenting on Tuspetinib with aza-ven in @YaleHematology double hit session
Excited to be heading to #EHA2026 and to open the oral presentations session for novel #AMLsm therapies with an exciting update on #KOMET007 study combination of #Ziftomenib with 7+3 which then will be closed by my @YaleCancer colleague Nikolai Podoltsev presenting on Tuspetinib with aza-ven in @YaleHematology double hit session
＜Novel Drug Approvals for 2025（FDA）🍀＞
□ #ziftomenib R/R AML with NPM1 mut. 11/13
□ #rilzabrutinib R/R ITP. 8/29
□ #linvoseltamab_gcpt R/R MM 4 prior Tx. 7/2
□ #fitusiran hemophilia A/B. 3/28
□ #treosulfan allo HSCT for AML/MDS(＋Flu）. 1/21
https://t.co/xarxk8wxIc 🚀
2025 approvals: 11 new drugs/indications for Hematologic malignancies by @US_FDA
1. #Acalabrutinib
2. #Brentuximab
3. #Tafasitamab
4. #Linvoseltamab
5. #Revumenib & #Ziftomenib
6. #Daratumumab x2
7. #Epcoritamab
8. #Pirtobrutinib
#HemeTwitter #OncTwitter
A 600 mg daily dose of the menin inhibitor #ziftomenib, combined with venetoclax and azacitidine, demonstrated robust clinical activity in patients with newly diagnosed, NPM1-mutated #AcuteMyeloidLeukemia #AML at an 84% CRc and an MRD-negative rate of 54%: https://t.co/ab00v13nIa
$KURA 🚨 ASH 2025 FRONTLINE BOMBSHELL Dec 8
Ziftomenib + ven/aza data in 1L NPM1-m AML
• updated R/R results
Two oral presentations 10:45 & 11:15 AM ET
PDUFA Nov 30 → $10B+ market unlock incoming
Menin revolution starts now 🔥📈
#ASH2025 #Ziftomenib #AML
@kuraoncology
💊#FDA Approval Update | #Komzifti (#ziftomenib) for relapsed or refractory #AML with #NPM1 mutation in adults
⚙️Blocks #menin-KMT2A interaction, disrupting leukemogenic gene expression
🌟MedChemExpress provides ziftomenib for research use.
#AcuteMyeloidLeukemia #Leukemia
We report in @BloodPortfolio today 📣
Now that we have an @US_FDA approved tx for #NPM1
mutated AML (@kuraoncology #ziftomenib) … good to be aware of this VERY rare #hemepath #zebra 🦓 : NPM1 mut AML with erythroid & megakaryocytic differentiation 😈
https://t.co/wECqSnKykV
One page takeaway/summary from our 🗣️ with @EuniceWangMD and KOMET-001 study that resulted in #Ziftomenib @FDAOncology approval on November 13, 2025 for NPM1+ Relapse/Refractory AML!
#OncTwitter #MedTwitter #HemeTwitter @OncUpdates
Ziftomenib is now @US_FDA approved for R/R AML w/ NPM1 mutation based off KOMET-001! We had a chance to 🗣️ this trial, findings, AEs, and dosing w/ @EuniceWangMD
Full 🗣️:
⭐️ https://t.co/mVJDI99hLN
⭐️ Also on “Oncology Brothers” podcast
#HemeTwitter @OncoAlert @OncUpdates
Follow @OncoAlert for the latest updates in the #Oncology #Hematology field 🔥
👇Below the latest update on the @US_FDA #FDA approval of #ziftomenib in #AML with #NPM1 mutation
#leukemia #leusm
FDA🚨approval
On November 13, 2025, the U.S. Food and Drug Administration approved ziftomenib, a menin inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) harboring a susceptible nucleophosmin 1 (NPM1) mutation who lack satisfactory alternative treatment options.
https://t.co/feVQSKmy2f
Approval was based on results from the KO-MEN-001 trial (NCT04067336), an open-label, single-arm, multicenter study involving 112 adults with NPM1-mutated AML. The trial demonstrated a 21.4% composite complete remission (CR + CRh) rate, with a median duration of response of 5 months. Additionally, 21.2% of transfusion-dependent patients achieved transfusion independence, while 26.1% of those already independent maintained that status during follow-up.
These findings establish ziftomenib as a novel targeted therapy option for this difficult-to-treat AML population.
@Abdallah81MD @FadiHaddad_MD
Novel Drug Approvals for 2025
What are "Novel" Drugs?
"Novel" drugs are new drugs never before approved or marketed in the U.S.
So far the FDA has already approved 36 Novel drugs YTD including #ziftomenib https://t.co/LOghwUA4K3
👉👉👉 @US_FDA approves #ziftomenib for relapsed or refractory acute myeloid leukemia with a #NPM1 mutation | #menin @GhayasIssa @EuniceWangMD @madanatyazan #leusm https://t.co/x8SLLiy1KK
#Ziftomenib in Relapsed or Refractory #NPM1-Mutated AML | Journal of Clinical Oncology @JCO_ASCO @ASCO | #leusm | @GhayasIssa https://t.co/0EnTbAnZjc
What a fantastic news and a big win for our patients and #AMLSm field. Very excited about the combination treatments that are being run with #ziftomenib. FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation | FDA https://t.co/VpOVLBQRid
Atentos a #KURA , la FDA antes del 30 de noviembre tiene que decidir sobre #ziftomenib . Se espera su aprobación.
Las curas contra el cáncer avanzan
November Biotech PDUFA Pulse:
📡 What’s on the FDA Radar
$ARWR - Plozasiran (ARO-APOC3)
$KURA - Ziftomenib
$ASND - TransCon CNP
See this month’s PDUFA calendar below.
Honored to present at the #4th Translational Summit on Heme Malignancies @DAVAOnc! Updates from the #KOMET007 #Ziftomenib combo trial - grateful to be part of an incredible Menin inhibitor session with such a stellar lineup. @LeukDocJZ @beatalleukemia @CarrawayHetty @jamesblachly
#Menin inhibitor race: $KURA's #ziftomenib vs $SNDX's #revumenib in race for approval in high-relapse NPM1-mutant #AML (~30% adult cases). Kura leads (NDA filed), Syndax follows (sNDA Q2 '25). Paradigm shift for high unmet need! Who wins? #oncology #cancerdrugs #cancerresearch
This weekend we presented encouraging clinical data with @KyowaKirin_US from the KOMET-007 trial of #ziftomenib in combination with 7+3 and ven/aza for patients with newly diagnosed or R/R NPM1-m or KMT2A-r #AML at #ASH2024. Learn more: https://t.co/uiwSp8Fqeb
@ASH_hematology
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