Cresemba (isavuconazonium sulfate) / Astellas, Basilea, Pfizer, Grupo Biotoscana, Hikma, Laboratoire Riva, Asahi Kasei, Knight Therap, MedCap AB - LARVOL DELTA

The effect of belumosudil on the therapeutic monitoring of tacrolimus and sirolimus in allogeneic hematopoietic transplantation (ASH 2025) - "Azoles were used concomitantly in 51.5% of patients (35/68), with 65.7% (23/35) on posaconazole, 31.4% (11/35) on isavuconazole, and 2.9% (1/35) on voriconazole. Four patients started an azole after starting belumosudil (2 on posaconazole, 1 on fluconazole, and 1 on isavuconazole)... Our study confirms the drug interaction between TAC/SIRO, with the increase in TAC/SIRO levels more pronounced with the second level after starting belumosudil. However, severe toxicities were rarely seen. Based on our data, we recommend close TDM of TAC and SIRO, but no dose adjustment is warranted when belumosudil is added."

Acute Kidney Injury • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Movement Disorders • Nephrology • Transplantation • CYP3A4

Comparative outcomes of posaconazole vs. voriconazole/isavuconazole for antifungal prophylaxis in neutropenic adults with Acute Myeloid Leukemia: A propensity-matched retrospective cohort study (ASH 2025) - "In this large, matched cohort of neutropenic AML patients, posaconazole prophylaxis was associated withimproved survival and reduced incidence of shock compared to voriconazole/isavuconazole, albeit at thecost of slightly increased hospitalization. These findings support the preferential use of posaconazole inselect high-risk AML populations, while highlighting the need for individualized risk–benefit assessmentin antifungal prophylaxis strategies."

Retrospective data • Acute Myelogenous Leukemia • Acute Respiratory Distress Syndrome • Candidiasis • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Ophthalmology • Respiratory Diseases

A phase 1/2 study of GB3226, a novel dual inhibitor of ENL-yeats and FLT3, in patients with relapsed/refractory Acute Myeloid Leukemia (ASH 2025) - P1/2 | "Phase 2 of the study aims at assessing the efficacy of GB3226, measured by the rate of completeremission (CR) and CR with partial hematologic recovery (CRh).Additionally, the study will explore pharmacodynamic (PD) markers in peripheral blood and bone marrowto elucidate GB3226's biological effects and identify potential biomarkers predictive of clinical response. This open-label, multicenter, seamless Phase 1/2 study will enrol adult patients (aged ≥18years) with R/R AML, who have failed at least one prior line of therapy (e.g., chemotherapy, venetoclax-based regimens). Phase 1 employs a dose-escalation design across three cohorts to assess the impact of CYP3A4 inhibitorson GB3226 PK and safety and define the maximal tolerated dose (MTD).Cohort A: No CYP3A4 modifiersCohort B: Coadministration with strong CYP3A4 inhibitors (e.g., voriconazole, and posaconazole)Cohort C: coadministration with moderate CYP3A4 inhibitors (e.g., isavuconazole)GB3226 is administered..."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • CD14 • FLT3 • HEY1 • HOXA9 • ITGAM • MEIS1

Cardiotoxicity associated with antifungal agents: A pharmacovigilance analysis of the FDA Adverse Event Reporting System. (PubMed, Int J Clin Pharmacol Ther) - "These findings highlight that azoles and polyenes show substantial associations with CAEs, particularly for TdP/QTP and arrhythmias. Itraconazole showed a significant association with cardiac failure and cardiomyopathy, while the signal for isavuconazole was weaker than for other triazoles. No significant cardiotoxicity signals were detected for echinocandins."

Adverse events • Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Ventricular Tachycardia

Non-Aspergillus molds. (PubMed, JHLT Open) - "In general, lipid preparations of amphotericin B or azole antifungals (voriconazole, posaconazole, isavuconazole) are frequently used for treatment. Investigational therapies such as fosmanogepix or olorofim are promising as future treatment modalities for some of these difficult-to-treat non-Aspergillus molds."

Journal • Review • Cardiovascular • Hematological Disorders • Infectious Disease • Neutropenia • Respiratory Diseases • Thrombosis • Transplantation

Phase 1 Study of Escalating Doses of Ibrutinib in Teddi-R with Isavuconazole for Relapsed and Refractory Primary DLBCL of the CNS (ASH 2024) - P1 | "We have previously shown that ibrutinib with temozolomide, etoposide, liposomal doxorubicin, dexamethasone, and rituximab (TEDDI-R) induces durable remissions in relapsed/refractory PCNSL without the need for consolidation, but risks Aspergillus (Lionakis et al...Pts received up to 6 cycles of TEDDI-R with intra-Ommaya cytarabine and no planned maintenance or consolidation...TEDDI-R induces a high rate of complete response in patients with relapsed/refractory PCNSL including those refractory to HD-MTX. Remissions can be durable without consolidation."

P1 data • Atrial Fibrillation • Cardiovascular • CNS Lymphoma • Dermatology • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Mucositis • Neutropenia • Primary Central Nervous System Lymphoma • Thrombocytopenia • Venous Thromboembolism • Ventricular Tachycardia

Evidence Based Approach of Antifungal Prophylaxis (AFP) in Hematological Malignancies (DGHO 2025) - "Ten trials with HMA monotherapy (n=1,185), 10 with HMA/venetoclax (n=956) and 4 with FLT3-inhibitors (n=273) were analyzed...No prospective RT for AFP with isavuconazole, rezafungin or olorofim are available.In pts receiving HMA therapy, IFI ranged between 1.6 and 10.3% while AFP was usually not given...In pts treated with midostaurin, two studies (n= 218 pts) reported 29 IFI (13.3%). A total of 20,753 AFP pts episodes (eps) were included since 1984 from 95 studies during CTx and 17,482 pts received AFP within a clinical trial for AFP from 1992 to 2022. Out of these, 7,586 received fluconazole (FLU), 4,080 were on trials with posaconazole (POS) or voriconazole (VOR), 1,717 received itraconazole (ITRA), 1,895 echinocandins and 1,594 amphotericin B (AmB)(AmB deoxycholate, liposomal AmB or inhalative AmB), respectively. In pts receiving novel targeted therapies (e.g."

Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology

Phase 2 Response-Adapted Study of Ibrutinib with Temozolomide, Etoposide, Liposomal Doxorubicin, Dexamethasone, and Rituximab (TEDDI-R) for Secondary CNS Lymphoma (ASH 2023) - P2 | "Pts receive isavuconazole as fungal prophylaxis throughout therapy... Pts with ibrutinib-responsive SCNSL achieve a high rate of CR to TEDDI-R, and preliminary data suggest these remissions are durable. Most ibrutinib-responsive tumors are CD10-negative and enriched for MCD and BN2. TEDDI-R can be delivered as an outpatient to pts of all ages."

P2 data • Anemia • Anorexia • Atrial Fibrillation • B Cell Lymphoma • Cardiovascular • CNS Lymphoma • CNS Tumor • Dermatology • Diffuse Large B Cell Lymphoma • Endocrine Disorders • Fatigue • Febrile Neutropenia • Hematological Malignancies • Human Immunodeficiency Virus • Hypotension • Infectious Disease • Lymphoma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Primary Central Nervous System Lymphoma • Renal Disease • Respiratory Diseases • Secondary Central Nervous System Lymphoma • Septic Shock • Thrombocytopenia • BCL2 • BCL6 • MME • MYC

The Use of Antifungal Prophylaxis Is Associated with Worse Outcomes in Patients with Newly Diagnosed AML Treated with Venetoclax/HMA: A Retrospective Analysis of Patients in the Flatiron Health Database (ASH 2024) - "Among patients who received AFP, 172 (41%) received fluconazole, 128 (30%) received voriconazole, 52 (12%) received isavuconazole, and 68 (16%) received posaconazole. This further limited the ability to assess how venetoclax doses were modified. Finally, there may have been selection bias with some patients receiving antifungal prophylaxis because of additional patient or disease-related characteristics that could have impacted outcomes."

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • ASXL1 • RUNX1 • TP53

Experience with isavuconazole in lung transplant recipients with Aspergillus isolation in respiratory tract specimens: A multicenter, observational study. (PubMed, JHLT Open) - "Aspergillosis-attributable mortality at the end of follow-up was 12.0%. ISA was well tolerated in LuTRs and proved to be effective for the treatment of invasive Aspergillus syndromes."

Journal • Observational data • Pulmonary Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Phase 1b Study of IDH Inhibition with Enasidenib and MEK Inhibition with Cobimetinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-Occurring IDH2 and RAS Signaling Gene Mutations (ASH 2024) - P1 | "Background : Targeting of methylation by mutant isocitrate dehydrogenase (IDH) has changed the therapeutic landscape of relapsed or refractory (R/R) AML, culminating in the approval of IDH inhibitors, enasidenib, ivosidenib, and olutasidenib. Concurrent RAS-signaling mutations represent a growing problem in the management of R/R IDH mutant AML, since they are associated with resistance to IDH inhibitors and other approved therapies such as venetoclax-based regimens...As enasidenib is a moderate CYP3A inducer, the protocol was amended to also allow concomitant use of the moderate CYP3A4 inhibiting antifungal, isavuconazonium sulfate (cresemba)...To date, four patients have enrolled with three patients completing at least 1 cycle of treatment. Enrollment is open at City of Hope and the Fred Hutchinson Cancer Center (NCT05441514)."

Clinical • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BRAF • IDH2 • KRAS • NF1 • NRAS • PTPN11 • RIT1 • TET2

Isavuconazole provides effective and tolerable antifungal prophylaxis for patients with acute myeloid leukemia. (PubMed, Leuk Res) - "Voriconazole has been a standard antifungal prophylactic (AFP) agent for patients with acute myeloid leukemia (AML) during neutropenia. Rates/classification of IFI, breakthrough IFI (bIFI) and IFI-free survival (IFI-FS) were comparable between azoles in both analyses. Isavuconazole is an effective AFP agent with a superior side-effect profile and should thus be considered as a promising AFP option for patients with AML."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology

40 Years of Preventing Fungal Infections in Hematological Malignancies - Lessons Learned from Clinical Trials with 20,753 Patients (ASH 2024) - "Out of these, 7,586 received fluconazole (FLU), 4,080 were included in trials with posaconazole (POS) or voriconazole (VOR), 1,717 received itraconazole (ITRA), 1,895 echinocandins and 1,594 amphotericin B (AmB)(AmB deoxycholate, liposomal AmB or inhalational AmB), respectively...No prospective studies for AFP with isavuconazole and new antifungal agents like rezafungin or olorofim are available...In those receiving venetoclax/HMA, AFP practices were heterogeneous and IFI incidence ranged from 5% to 16.1% (overall probable/proven IFI : n=102 (10.6%), possible IFI not reported in all studies). In pts treated with midostaurin, 2 studies (n= 218 pts) reported 29 probable/proven IFI (13.3%). In pts treated with gilteritinib, 2 studies reported 55 pts with an IFI rate of 27.2% (including possible IFI)...Despite numerous trials for prevention of IFI, only posaconazole and fluconazole proved reduction in OM rates. There is a need for prospective clinical trials addressing..."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology

Invasive mould infection in children - advances made or obstacles remaining? (PubMed, Clin Microbiol Infect) - "There has been much progress in IMI management with recent development of novel diagnostic methods, new antifungals, and immunotherapeutic approaches. Ongoing paediatric studies are required to inform optimal implementation of these tools into clinical practice."

IO biomarker • Journal • Review • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases

Simulation of perioperative Ibrutinib withdrawal using a population pharmacokinetic model and sparse clinical concentration data. (PubMed, Cancer Chemother Pharmacol) - "Perioperative withdrawal of ibrutinib was explored using a previously reported PopPK model in combination with sparse plasma concentration data obtained from patients in real-world clinical settings, including those undergoing surgery. This exploratory study suggests that reliance on plasma concentration data alone might be inadequate for determining the optimal perioperative withdrawal period of ibrutinib."

Journal • PK/PD data

A Case of Signal Transducer and Activator of Transcription 1 Gain of Function Mutation (ACAAI 2025) - "Discussion Despite increased in CXCL9 in response to Ruxolitinib; fungal infection has been difficult to control while on isavuconazole and ruxolitinib for approximately 12 and 9 months respectively. Antifungals was changed to high dose Posaconazole with Terbinafine. Patient is currently under medical preparation for hematopoietic stem cell transplant."

Clinical • Anemia • Atopic Dermatitis • Bone Marrow Transplantation • Dermatitis • Dermatology • Endocrine Disorders • Hematological Disorders • Immunology • Infectious Disease • Seborrheic Dermatitis • CD4 • CXCL9 • IL17A • STAT1

Diagnostic Complexity of Cavitary Lung Lesions: A Case of Overlapping Malignancy and Fungal Infection (APSR 2025) - "Positive TB Quantiferon test suggested LTBI.He was started on isoniazid and rifampicin for LTBI, isavuconazole for IPA, and underwent total hip arthroplasty. Following whole-brain radiotherapy, he was initiated on Pembrolizumab, Paclitaxel, and Carboplatin for stage IVB NSCLC...LTBI was suggested by TB Quantiferon. A systematic, multidisciplinary approach is essential to differentiate malignancy from coexisting infections, optimizing outcomes in complex cases."

Clinical • Infectious Disease • Lung Cancer • Musculoskeletal Diseases • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Tuberculosis

Contribution of the CYP51A Y119F Mutation to Azole Resistance in Aspergillus flavus. (PubMed, J Fungi (Basel)) - "The Y119F mutation reduced susceptibility specifically to voriconazole and isavuconazole, while susceptibility to itraconazole and posaconazole remained unchanged. Tunnel analysis further indicated that the Y119F substitution caused narrowing and shortening of the main access tunnels to the heme-binding pocket, likely impairing azole access and binding. The combined biochemical and structural analyses suggest that Y119F represents a primary resistance-conferring mutation that modifies the structural dynamics of CYP51A."

Journal • Pulmonary Disease • Respiratory Diseases

How to use novel antimicrobials beyond official indications: an expert consensus. (PubMed, JAC Antimicrob Resist) - "The process comprised three survey rounds evaluating off-label uses of eight drugs: ceftazidime-avibactam, ceftolozane-tazobactam, cefiderocol, ceftaroline, ceftobiprole, dalbavancin, tedizolid, and isavuconazole. The guidance prioritizes targeted treatment over empirical use, aligning with international ASP principles and WHO recommendations. These results provide a regional reference to optimize ASP initiatives focus on new antibiotic use while minimizing ecological impact and resistance development."

Journal • Cardiovascular • Critical care • Infectious Disease

Pharmacovigilance analysis of myopathy associated with azoles and nonstatins interactions based on US FAERS database. (PubMed, Sci Rep) - "Voriconazole, fluconazole, and itraconazole were associated with myopathy in narrow and broad SMQ searches. Posaconazole and isavuconazole were associated with myopathy in the broad SMQ search...Azoles, particularly voriconazole in East Asian populations, are associated with an increased reporting frequency of myopathy events in the absence of statin use. DDIs with some nonstatins further elevate this frequency."

Adverse events • Journal • Myositis

British Society for Medical Mycology best practice recommendations for the diagnosis of serious fungal diseases: 2025 update. (PubMed, Lancet Infect Dis) - "Based on recent evidence, new or stronger recommendations include use of Pneumocystis PCR; 1,3-β-D-glucan testing for suspected invasive candidiasis and Pneumocystis pneumonia; higher volume respiratory sample cultures; Aspergillus antigen or antibody-based testing in expanded clinically vulnerable populations, including patients in intensive care units and patients with chronic respiratory disease (including asthma); use of Candida PCR and Mucorales PCR in specific contexts; pan-fungal PCR and DNA sequencing for fungal identification from positive microscopy or histopathology specimens; and inclusion of posaconazole and isavuconazole in therapeutic antifungal monitoring recommendations. Recommendations are presented as auditable standards to facilitate implementation and quality improvement measures. An emphasis on integration of combined diagnostics with antifungal stewardship and clinical pathways extends guideline relevance beyond microbiology laboratories to..."

Journal • Review • Asthma • Candidiasis • Critical care • Immunology • Infectious Disease • Pediatrics • Pneumonia • Pulmonary Disease • Respiratory Diseases

Verruconis gallopava: an isavuconazonium foe. (PubMed, ASM Case Rep) - "His symptoms persisted, and he was transitioned to liposomal amphotericin B and eventually oral posaconazole (POS) with clinical and radiographic resolution of his presenting syndrome. Transitioning to POS led to clinical improvement, suggesting its potential as a treatment option. Further experience is needed to establish optimal therapeutic strategies for this rare but serious infection."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases • Transplantation

First Report of Cystobasidium slooffiae in Human Wounds from China: Molecular Identification and Clinical Insights. (PubMed, Infect Drug Resist) - "Both strains exhibited high minimum inhibitory concentrations (MICs) for all three echinocandins (>8 µg/mL) and fluconazole (32-64 µg/mL), whereas the MICs for isavuconazole were in the range 0.75-1 µg/mL. Erg11 sequence analysis revealed they formed a distinct clade that was genetically distant from Rhodotorulaceae. Our findings showed that C. slooffiae could be an important emerging, opportunistic human invasive fungal pathogen because of its reduced susceptibility to echinocandins and fluconazole."

Journal • Infectious Disease

Incidence of Invasive Fungal Infections in CAR T-Cell Therapy Recipients: A Single-Center Retrospective Analysis (ASH 2023) - "All patients received prophylactic antifungal agents, including anti-yeast (fluconazole, n=95), and anti-mold (micafungin n=5, isavuconazole n=1, or Posaconazole n=52). The rate of IFI in our cohort was low (0. 7%) post-CAR T therapy. The diagnostic performance of serial monitoring of B-DG and GM for the diagnosis of IFI is poor in recipients of BCMA-directed CAR T therapy for MM or CD19-directed CAR T for NHL."

CAR T-Cell Therapy • IO biomarker • Retrospective data • Dermatology • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Breaking the mold: a case of invasive Medicopsis romeroi pulmonary infection with innovative granulocyte treatment strategy. (PubMed, ASM Case Rep) - "The nodules progressed despite a combination of posaconazole, isavuconazole, terbinafine, and liposomal amphotericin B. A course of HLA-compatible granulocytes was initiated, resulting in stabilization of the infection. This is a rare case of M. romeroi causing an invasive fungal infection of a visceral organ, the second documented M. romeroi infection in a CGD patient, and a report of a novel treatment regimen for this pathogen."

Journal • CNS Disorders • Immunology • Infectious Disease • Primary Immunodeficiency • Respiratory Diseases • Ventriculomegaly