midostaurin / Generic mfg. - LARVOL DELTA

Chromosomal Heterogeneity and Enrichment of Mitotic Regulatory Programs Reveal a Therapeutic Vulnerability in Cytarabine-Resistant FLT3-ITD AML. (PubMed, Curr Issues Mol Biol) - "Notably, combined TTK/Mps1 and FLT3 inhibition with luvixasertib and midostaurin synergistically suppressed cell viability in both resistant cell lines. These findings identify divergent FLT3 regulation, DCK downregulation, increased chromosomal heterogeneity, and enrichment of mitotic regulatory programs as key features associated with acquired cytarabine resistance. They also support the combined inhibition of TTK/Mps1 and FLT3 as a potential therapeutic strategy for cytarabine-resistant FLT3-ITD AML."

Heterogeneity • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • DCK • FLT3

Identification of repositioned inhibitors of pan-cancer proteasomal target as potential anti-proliferative candidates using a computational therapeutics approach. (PubMed, Biochem Biophys Res Commun) - "The compounds anisomycin, cephaeline, digitoxin, mitoxantrone, digoxin, digitoxigenin, homoharringtonine, NCI724448, midostaurin, withaferin A and NCI718581 were found to be effective UBE2C targeting candidates which could result in significant growth inhibition at low doses across multiple cell lines. Our results lay a strong groundwork for further preclinical exploration of the efficacy of these compounds against different cancers individually as also in combination with existing therapeutics for their future development as novel anticancer drugs."

Journal • Oncology • Targeted Protein Degradation • TP53 • UBE2C

Outcomes after Transplant in Relapsed/Refractory KMT2Ar (MLLr) and mNPM1 (NPM1c) leukemia Patients Achieving Remissions after Menin Inhibition: SNDX-5613 (revumenib) Ph1 Experience (ASH 2022) - P1/2 | "1 was among the 12 patients described in Table 1: a 40 yo F with KMT2Ar AML with FLT3 TKD, and 3 prior lines of therapy including 7+3+midostaurin and HSCT...She then had a molecular relapse and received CPX-351, gemtuzumab, venetoclax, and azacytidine, a 3rd allo-HSCT, and due to persistent positive MRD by flow, she received a donor lymphocyte infusion... In SNDX-5613 patients proceeding to transplant, durable remissions occurred across a range of heavily pre-treated patients. In addition to patients achieving CR/CRh, two patients with CRp also had ongoing remissions post-transplant. AUGMENT-101 continues to enroll patients, agnostic of transplant eligibility, with the option for SNDX-5613 post-transplant maintenance."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock • Transplantation • FLT3 • KMT2A • NPM1

Dual Targeting of FLT3 Signaling and BCL2 Dependency by Venetoclax in ATO-Resistant FLT3-ITD Acute Promyelocytic Leukemia (SOHO 2026) - "Next, IC50 values for midostaurin and venetoclax were determined, and their effects on FLT3 downstream signaling were evaluated. These findings establish venetoclax-based therapy as a rational preclinical strategy for ATO-resistant FLT3-ITD+ APL and support its further clinical evaluation. APL: acute promyelocytic leukemia, ATO: arsenic trioxide, ATRA: all-trans retinoic acid, BCL-xL: B-cell lymphoma-extra large, FLT3-ITD: fms-like tyrosine kinase 3 internal tandem duplication, IC50: half-maximal inhibitory concentration, MSCV-IRES-GFP: murine stem cell virus–internal ribosome entry site–green fluorescent protein, NOD/SCID: non-obese diabetic severe combined immunodeficient, PML-RARA: promyelocytic leukemia/retinoic acid receptor alpha, pSTAT5: phospho-STAT5, STAT5: signal tranducer and activation of transcription 5."

IO biomarker • Acute Promyelocytic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL2L1 • FLT3 • PML • PTPRC • RARA • STAT5

GILTERITINIB VERSUS MIDOSTAURIN IN PATIENTS WITH NEWLY DIAGNOSED FLT3-MUTATED ACUTE MYELOID LEUKEMIA ELIGIBLE FOR INTENSIVE THERAPY: RESULTS FROM THE PHASE 3 HOVON156/AMLSG28-18/PASHA TRIAL (EHA 2026) - P3 | "Pts were randomized to induction chemo (cycle 1: standard 7+3 [cytarabine + anthracycline]; cycle 2: daunorubicin + intermediate-dose cytarabine) + either oral GILT (120 mg once daily) or MIDO (50 mg twice daily) on days 8–21. Consolidation for pts in complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) consisted of chemo (intermediate-dose cytarabine or mitoxantrone/etoposide) + GILT or MIDO; or autologous/allogeneic hematopoietic stem cell transplantation (auto/alloHSCT) with GILT or MIDO maintenance for 1 y. Eligible pts (≥18 y) had ND FLT3 mut+ AML, ECOG PS ≤2 and were fit for intensive chemo...Summary/Conclusion Survival outcomes for GILT were not significantly different from MIDO in ND FLT3 mut+ AML, thus the primary endpoint was not met. A clinically meaningful RFS advantage with GILT vs MIDO did not translate into an OS benefit, likely due to more frequent use of GILT and alloHSCT as salvage therapy..."

Clinical • Late-breaking abstract • P3 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • FLT3 • NPM1

Long-Term Survival Outcomes and Cytogenetic/Molecular Patterns of Relapse in Adults with FLT3-Mutated AML Receiving Frontline Triplet Therapy with a Hypomethylating Agent, Venetoclax and FLT3 Inhibitor (ASH 2024) - "The FLT3i used was gilteritinib in 61 pts (69%), quizartinib in 18 (21%), sorafenib in 7 (8%), and midostaurin in 2 (2%). A majority of relapses are driven entirely by FLT3 wild-type clones. RAS pathway mutations at diagnosis are associated with worse outcomes, and new RAS pathway mutations were observed in 20% of relapses."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BRAF • FLT3 • GATA2 • IKZF1 • KRAS • NF1 • NPM1 • NRAS • PTPN11 • RUNX1 • SF3B1 • TET2 • WT1 • ZRSR2

Actinomycin D in Combination With Low-Dose Cytarabine and Venetoclax in Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia (SOHO 2026) - "Seventy-four percent were previously exposed to intensive chemotherapy ± midostaurin, whereas 26% were treated with HMA± venetoclax. FLT3 comutations were identified, and additional gilteritinib was used in 63% of cases... The ACTIVE regimen demonstrates promising efficacy and tolerability in R/R NPM1m AML. Further evaluation in clinical trials is warranted. CR, complete remission, CRh: complete remission with partial hematologic recovery, CRi: complete remission with incomplete hematologic recovery, CRp: complete remission with incomplete platelet counts, MLFS: morphologic leukemia-free state."

Combination therapy • Acute Myelogenous Leukemia • Colorectal Cancer • Hematological Malignancies • Leukemia • Oncology • FLT3 • NPM1

ORAL AZACITIDINE VS MIDOSTAURIN AS MAINTENANCE TREATMENT FOR FLT3 MUTANT ACUTE MYELOID LEUKEMIA IN COMPLETE REMISSION: AN INDIRECT TREATMENT COMPARISON (EHA 2022) - P3 | "Limitations included trial differences and small sample size. More research is needed to support this observation."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3

Venetoclax plus intensive chemotherapy with cladribine, idarubicin, and cytarabine in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome: a cohort from a single-centre, single-arm, phase 2 trial. (PubMed, Lancet Haematol) - P2 | "Venetoclax added to CLIA was safe and active in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome, producing high rates of durable MRD-negative remissions and encouraging event-free survival and overall survival."

Clinical • IO biomarker • Journal • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • FLT3

Survival Benefit of FLT3 Inhibitor Maintenance After Allo-HSCT in FLT3-ITD AML: A Systematic Review and Reconstructed Individual Patient Data Meta-Analysis of Randomized Controlled Trials (SOHO 2026) - " PubMed, Embase, and Scopus were systematically searched from database inception through April 2026 for randomized phase 2/3 trials evaluating FLT3 inhibitor maintenance (sorafenib, midostaurin, or gilteritinib) vs standard care alone in adults with FLT3-ITD AML in complete remission following allo-HSCT. FLT3 inhibitor maintenance after allo-HSCT was associated with significantly improved RFS and OS in adults with FLT3-ITD AML. These findings support the incorporation of posttransplant FLT3 inhibitor maintenance into treatment strategies in eligible patients. Further prospective studies are warranted to define optimal agent selection, treatment duration, and minimal residual disease-guided approaches."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety and Efficacy of G-CSF with Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia: A Subgroup Analysis of the Phase II Trial of Venetoclax in Combination with Cladribine, Idarubicin, and Cytarabine (ASH 2024) - P2 | "The trial allowed treating physicians to use filgrastim 300–480 µg daily for prolonged neutropenia or neutropenic fever; a trial amendment integrated pegfilgrastim at a dose of 6 mg SQ once between D5–9 of each cycle...Sixteen (18%) patients had FLT3-ITD — 8 (9%) received gilteritinib and 1 (1%) received midostaurin...FLT3-ITD AML was associated with delayed count recovery, likely due to concurrent TKI use. G-CSF use had no impact on the incidence of AML relapse."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • ASXL1 • BCOR • BCR • FLT3 • KRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • U2AF1 • ZRSR2

Cytomolecular mechanisms of relapse after frontline FLT3 inhibitor (FLT3i)-based therapy in FLT3-mutated (mut) acute myeloid leukemia (AML). (ASCO 2025) - "Induction therapy was intensive chemotherapy (IC) in 107 pts and low intensity therapy (LIT) in 165 pts [including HMA+venetoclax(VEN)+FLT3i in 93 pts]. FLT3i's used were gilteritinib (n=105), sorafenib (n=96), quizartinib (n=54), midostaurin (n=16), and crenolanib (n=1)... Loss of FLT3 mut at relapse occurred in almost 50% of pts receiving frontline FLT3i and was more common in pts receiving IC+FLT3i or HMA+VEN+FLT3i. Common mechanisms of clonal evolution included emergent mutations in RAS pathway, WT1, and DNA methylation genes (TET2, IDH1/2). Mutational clonal evolution was less frequent in post-ASCT relapses."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • FLT3 • IDH1 • IDH2 • TET2 • WT1

Comparative Efficacy and Safety of FLT3 Inhibitor–Based Frontline Regimens in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia: A Systematic Review and Network Meta-Analysis (SOHO 2026) - "Introduction: The rapid expansion of FLT3 inhibitors (FLT3i) and venetoclax (VEN)-based combinations has transformed the frontline landscape for FLT3-mutated AML...Gilteritinib-based triplets achieved the highest complete response/ complete remission with incomplete count recovery (CR/Cri) rates (OR, 3.15; 95% CI, 2.10–4.72) and measurable residual disease negativity (OR, 2.80; 95% CI, 1.65–4.75) vs midostaurin + 7+3, although OS benefit was partially offset by early mortality. For hypomethylating agent backbones, VEN + FLT3i triplets outperformed VEN + AZA (azacitidine) doublets in event-free survival (HR, 0.68; 95% CI, 0.49–0.94)... While triplet therapies offer the deepest molecular responses, quizartinib-based intensive induction currently represents the most favorable balance of survival and safety for fit patients; notably, the overall risk of bias across included studies was low. 7+3: 7 days of cytarabine and an anthracycline for the first 3 days, ASH: American..."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Postmarketing Safety Signals of Revumenib (Menin-KMT2A Inhibitor) vs Acute Myeloid Leukemia-Targeted Therapies: A Class-Restricted Disproportionality Analysis of the FDA Adverse Event Monitoring System (2016–2026) (SOHO 2026) - " AE reports (January 2016–April 2026) were extracted for revumenib (n = 716) and eight targeted AML therapies (n = 70179): ziftomenib, enasidenib, ivosidenib, olutasidenib, gilteritinib, midostaurin, quizartinib, and venetoclax. Analysis of 716 revumenib reports (median age, 50 years; 50.2% male; 57.5% US-sourced; 55.6% serious) identified AML as the recorded indication in 59.2% of cases. Eleven AEs qualified as robust signals. Established toxicities included differentiation syndrome (n = 32; ROR, 9.12; 95% CI, 6.31–13.20), QTc prolongation (n = 29; ROR, 8.88; 95% CI, 6.03–13.08), and decreased platelet count (n = 113; ROR, 3.91; 95% CI, 3.19–4.79)."

Adverse events • Clinical • P4 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • KMT2A

Cheminformatic identification of small molecules targeting acute myeloid leukemia. (PubMed, Leukemia) - "Finally, we also observed strong synergy between these compounds and midostaurin and venetoclax, underscoring their therapeutic potential. Key phenotypes, including the compounds' impact on glutathione metabolism and synergy with doxorubicin and midostaurin, were confirmed in AML-patient-derived primary cells, validating the potential of these compounds for the development of future AML treatments."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Novel inhibitors of BCRP found among drugs used in the treatment of cancer. (PubMed, Eur J Pharm Sci) - "Moreover, the model suggested that midostaurin, cabozantinib, and alpelisib could almost fully inhibit intestinal BCRP, nearly doubling rosuvastatin exposure (1.83- to 1.94-fold). Entrectinib, alpelisib, flutamide, abiraterone, and capecitabine were predicted to increase rosuvastatin exposure by 1.45- to 1.63-fold through BCRP inhibition. FAERS analysis indicated a higher frequency of rhabdomyolysis reports when abiraterone was co-administered with rosuvastatin compared with all reports without abiraterone, with a reporting odds ratio of 17.3. This study identified multiple previously unrecognized BCRP inhibitors, highlighting the potential for clinically relevant BCRP‑mediated drug-drug interactions in oncology patients."

Journal • Breast Cancer • Oncology • Solid Tumor

EP0042, a Dual FLT3 and Aurora Kinase Inhibitor: Preliminary Results of an Ongoing Phase I/IIa First in Human Study in Patients with Relapsed/Refractory Acute Myeloid Leukemia (ASH 2022) - "EP0042 has resulted in inhibition of tumor growth in FLT3-ITD and FLT3-ITD-TKD human tumor xenograft models and in quizartinib-resistant primary AML samples (Moore A et al...5 pts received a prior FLT3 inhibitor including midostaurin, gilteritinib or sorafenib...The dose escalation is continuing at intermittent and continuous dosing to establish the MTD and optimal RP2D dose for further evaluation. Once a RP2D is confirmed, a single arm dose expansion is planned in FLT3 mutated and wild type R/R AML, and the combination of EP0042 with other agents will be explored."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Ataxia • Fatigue • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Movement Disorders • Neutropenia • Oncology • AURKB • FLT3 • STAT5

A Phase II Randomized Trial Comparing Low-Dose Cytarabine and Venetoclax +/- Midostaurin in Non-Adverse Cytogenetic Risk Acute Myeloid Leukemia: The ALLG AMLM25 Intervene Trial (ASH 2024) - "Background For fit patients (pts), combining kinase inhibitors (midostaurin, quizartinib) with intensive chemotherapy is standard of care for FLT3mutated AML...Clonal evolution of kinase-activating mutations, including FLT3-ITD is an important mechanism of treatment failure in pts with non-adverse (NON-ADV) cytogenetic risk AML receiving frontline therapy with azacitidine and venetoclax (AZA-VEN) (DiNardo and Tiong et al, Blood 2020). Incorporating kinase inhibitors (e.g. gilteritinib) into less-intensive VEN-based regimens in unfit, older pts has been challenging, with cumulative myelosuppression a dominant issue (Short et al, JCO 2024)...Posaconazole antifungal prophylaxis was permitted with dose adjustment of VEN to 50 mg daily and MIDO to 50 mg daily due to increased risk of cardiac toxicities in older populations...FLT3­-ITD MRD clearance was observed in 9/15 (60%) in the LVM arm and 1/4 (25%) in the LV arm. Conclusion In unfit, older pts ≥60 years with newly..."

Clinical • P2 data • Acute Myelogenous Leukemia • Constipation • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Neutropenia • FLT3

Survival and Toxicity Trade-Offs With Anthracycline-Based Induction vs Non-Anthracycline Therapy in Newly Diagnosed Acute Myeloid Leukemia: A Real-World Propensity-Matched Analysis (SOHO 2026) - "Anthracycline cohort (n = 9727): daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone. Nonanthracycline cohort (n = 6649): azacitidine, decitabine, venetoclax, glasdegib, gilteritinib, enasidenib, ivosidenib, midostaurin; anthracyclines excluded... Anthracycline induction was associated with 27% lower 3-year mortality but higher acute toxicity—36% more hospitalization, 23% bleeding, 13% VTE, 11% MACE—reflecting the risk-benefit profile of intensive induction. Selection of fitter patients with favorable AML biology likely contributes through residual confounding despite PSM. These findings reinforce integrating fitness, cytogenetic/molecular risk, and patient preference into the frontline regimen choice."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

V-FAST Master Trial: Subgroup Analysis of Outcomes with CPX-351 Plus Midostaurin in Adults with Newly Diagnosed Acute Myeloid Leukemia By FLT3 Mutation Type (ASH 2022) - P1b | "V-FAST (Vyxeos – First Phase Assessment with Targeted Agents) is an open-label, multicenter, multi-arm, nonrandomized, phase 1b master trial (NCT04075747) to evaluate the safety and preliminary efficacy of CPX-351 combined with targeted agents (MID, venetoclax, enasidenib)...In conclusion, preliminary results from the V-FAST trial suggest the combination of CPX-351 + MID is feasible with a manageable safety profile and promising remission rates in adults with newly diagnosed, FLT3-mutated AML. Although conclusions are limited by the small numbers of patients in each subgroup, results are generally consistent for patients with FLT3 ITD and TKD mutations."

Clinical • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • Transplantation • FLT3

Upfront Triple Therapy With FLAG-Venetoclax Backbone in Intensive Chemotherapy-Eligible FLT3-ITD Patients With AML: Preliminary Results From a Retrospective Cohort (SOHO 2026) - "Design: We performed a single-center retrospective study of 14 patients with newly diagnosed fmslike tyrosine kinase 3 (FLT3)-positive AML who were treated with an upfront FLAG-VEN–midostaurin-based triplet induction from March 2023 to January 2026. This single-center experience suggests that upfront FLAG-VEN-based triple therapy is a feasible and active induction strategy for individuals newly diagnosed with AML, with promising remission and MRD-negative responses in a high-risk real-world patient population. Larger studies are needed to confirm the durability of response and define the safety profile. FLAG-VEN: fludarabine, arabinofuranosyl cytidine, granulocyte colony-stimulating factor + venetoclax; FLT3-ITD: internal tandem duplication mutation in the FLT3 gene; VEN: venetoclax."

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

FLAG-Ida Combined with Gemtuzumab Ozogamicin (GO) Improves Event Free Survival in Younger Patients with Newly Diagnosed Acute Myeloid Leukaemia (AML) and Shows an Overall Survival Benefit in NPM1 and FLT3 mutated Subgroups. Results from the UK NCRI AML19 Trial (ASH 2022) - "The MRC AML15 trial suggested a higher response rate and reduced relapse risk with FLAG-Ida compared to a Daunorubicin-araC (DA) +etoposide but did not show an overall survival (OS) benefit (Burnett, JCO,2013,31,3360). Furthermore this survival benefit was associated with a reduction in the requirements for transplant in CR1 and overall. Given the benefit observed in FLT3 mutated AML in the absence of a FLT3 inhibitor, studies combining FLAG-Ida-GO with Midostaurin are warranted."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3 • NPM1

10 Year Follow-up of CALGB 10603/Ratify: Midostaurin Versus Placebo Plus Intensive Chemotherapy in Newly Diagnosed FLT3 Mutant Acute Myeloid Leukemia Patients Aged 18-60 Years (ASH 2024) - "Subsequently, additional targeted drugs including gilteritinib for relapsed/refractory FLT3-mutant AML and quizartinib plus chemotherapy in untreated adults with AML with FLT3-ITD disease have gained approval...Methods : C10603 enrolled 717 pts (360 on the M and 357 on the P arm; median age 47.8 years (range 18-61), 398 women (55.5%) of whom 51.7% were randomized to M and 59.4% to P (p=0.04), and 89% white) from 2011-2015 with previously untreated AML who had either a FLT3-TKD or ITD mutation with allelic ratio of >0.05 to receive daunorubicin/cytarabine (3+7) induction (one reinduction permitted) followed by up to 4 consolidation cycles with cytarabine 3 g/m2 every 12h on days 1, 3 and 5...Conclusions : The EFS benefit of randomization to midostaurin vs placebo when added to chemotherapy was maintained over time, although the benefit for OS was diminished, likely due in part to aging. Patient and disease factors differed between early vs late relapses, which could..."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Gilteritinib Results in Higher Remission and Transplant Rates Than Midostaurin but Does Not Increase the Post-Induction Mutational MRD Negative Rate: Results of the Phase 2 Randomized Precog 0905 Study in Newly Diagnosed FLT3 Mutated AML (ASH 2024) - "Induction consisted of cytarabine 100 mg/m2 by continuous infusion daily, on day (d) 1-7 and daunorubicin 90 mg/m2 IV on d 1-3. Future survival data will help evaluate the clinical impact of G and MRD assessments in ND FLT3mAML. Larger studies will be needed to establish most predictive timing of MRD and for definitive comparisons of these drugs in patients with specific mutation profiles ( ie TKD, ITD/NPM1/DNMT3)."

Clinical • Minimal residual disease • P2 data • Acute Myelogenous Leukemia • Transplantation • DNMT3A • FLT3 • NPM1

Phenotype-Specific Safety Differences Between Gilteritinib and Midostaurin in AML: A FAERS Analysis Highlighting Differentiation Syndrome Signal (SOHO 2026) - "In this AML-restricted FAERS analysis, gilteritinib and midostaurin demonstrated comparable overall cardiac safety signals, with a nonsignificant trend toward increased QT prolongation with gilteritinib. A marked disproportionality signal for differentiation syndrome with gilteritinib represents the most clinically relevant safety difference between agents. These findings highlight distinct phenotype-specific safety patterns and support phenotype-directed monitoring strategies, while underscoring the need for confirmatory studies using controlled data sources, as these observations are hypothesis-generating."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3