Drug Database
IB

ibrutinib

✓ Approved

Johnson & Johnson Services, Inc. · Companion diagnostic · Companion diagnostic

What is ibrutinib?

ibrutinib is a companion diagnostic developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications via others.

Drug Profile

CompanyJohnson & Johnson Services, Inc.
Drug ClassCompanion diagnostic
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Johnson & Johnson Services, Inc.

Therapeutic Indications

ibrutinib is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

Related Research Articles

PubMedHematological oncology2026-05-24

Real-World Treatment Patterns and Healthcare Resource Utilization of Bruton Tyrosine Kinase Inhibitors for the Treatment of Mantle Cell Lymphoma in the United States.

Shah Bijal B, Xue Mei M, Furnback Wesley W, Esselman Kaitlyn K et al.

The introduction of Bruton tyrosine kinase inhibitors (BTKis) to the mantle cell lymphoma (MCL) treatment paradigm has shown promising results for patient outcomes. However, insufficient real-world evidence remains to compare the outcomes of different BTKi treatments in MCL. This study aimed to analyze BTKi utilization and differences in patient characteristics, treatment outcomes, and healthcare resource utilization among patients with MCL during their first use of BTKi therapy. A retrospective study was conducted using Symphony Integrated Dataverse (IDV), which is a longitudinal, de-identified U.S. healthcare claims database. The study included patients with MCL with their first BTKi administered as monotherapy or in combination with other agents between 1/1/2020 and 12/31/2022. Patients were followed at least 90 days after BTKi initiation until the end of the study period or until lost to follow-up (3/31/2023). Patient demographics and clinical characteristics were measured at baseline. Time to discontinuation, treatment duration, switching, compliance, and healthcare resource utilization (per patient per month [PPPM]) were measured during the follow-up period. A total of 1458 patients initiating their first BTKi were included in the study: 667 in the acalabrutinib group, 509 in the ibrutinib group, and 282 in the zanubrutinib group. Switching rates within 90 days were lowest for the zanubrutinib group (0.71%), followed by the acalabrutinib group (1.8%) and then the ibrutinib group (2.16%). The median time to discontinuation was longest for the zanubrutinib group (188.5 days) compared to the acalabrutinib group (179 days) and the ibrutinib group (161.5 days). Compliance at 360 days was significantly different across the BTKis, highest for the zanubrutinib group (16.9%), followed by the acalabrutinib group (13.2%) and the ibrutinib group (10.8%). The zanubrutinib group had numerically lower mean PPPM outpatient visits and inpatient services than the acalabrutinib and ibrutinib groups. This real-world study suggested that the zanubrutinib group demonstrated lower switching rates, longer time to discontinuation, improved compliance, and less healthcare resource use compared to the acalabrutinib and ibrutinib groups in patients with MCL.

PMID 42176276
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PubMedBreast cancer (Tokyo, Japan)2026-05-24

Real-world uptake of gBRCA testing as a companion diagnostic for olaparib in patients with high-risk HER2-negative early breast cancer in Japan: a cross-sectional multicenter study (BRCAwareness).

Taji Tomoe T, Uemura Yukari Y, Kimura Yuri Y, Maeda Noriko N et al.

Adjuvant olaparib significantly improves invasive disease-free and overall survival in high-risk human epidermal growth factor receptor 2 (HER2)-negative, early breast cancer patients carrying germline breast cancer susceptibility gene 1/2 (gBRCA) pathogenic variants (PVs). Timely gBRCA testing as a companion diagnostic for adjuvant olaparib is essential. However, its real-world uptake remains unclear. We enrolled patients with invasive HER2-negative early breast cancer who underwent curative surgery during 2023 in Japan. Eligibility was based on the OlympiA trial criteria. Estrogen receptor (ER)-positive patients required ≥ 4 positive nodes after surgery or non-pathological complete response (non-pCR) with clinical and pathologic stage (CPS) and estrogen receptor status and histologic grade (EG) score ≥ 3 following neoadjuvant chemotherapy (NAC). ER-negative patients required invasive tumor > 2 cm or ≥ 1 nodal metastasis after surgery, or non-pCR after NAC. The primary outcome was gBRCA testing rate; secondary outcomes included a proportion of patients with gBRCA PVs and a proportion of patients starting adjuvant olaparib. We also explored factors associated with not undergoing testing. Of 824 patients enrolled from 46 facilities, 691 were analyzed after random sampling and exclusions. The testing rate was 63.2% (95% confidence interval 59.5-66.9). Among 254 untested patients, 168 (66%) were not informed-mainly due to physician oversight in recognizing eligibility (57%) or physician-perceived patient ineligibility (40%). Of 69 informed but untested patients, reasons included psychological distress (46%), testing cost (35%), and familial concerns (12%). Of 42 patients (9.6%) with gBRCA PVs, 32 received olaparib. Multivariable analysis (female only) showed that age ≥ 65 years, postmenopausal status, major comorbidities, upfront surgery, absence of family history of hereditary breast and ovarian cancer-related cancers, and absence of bilateral or multiple primary breast cancers were associated with lower testing rates. Greater physician awareness of companion diagnostic is needed to ensure timely gBRCA testing and equitable access to adjuvant olaparib.

PMID 42176176
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PubMedVeterinary research communications2026-05-24

Diagnosis of acetaminophen and codeine poisoning in a dog using earwax analysis by headspace gas chromatography-mass spectrometry (HS/GC-MS).

de Vicente Monica Chacon MC, Barros Alexandre Có Mangoni ACM, de Souza Gabriela Scarpin GS, di Pauli Taborda Prado Lais L et al.

Poisoning of companion animals resulting from exposure to analgesics intended for human use is a frequent and clinically relevant problem in veterinary practice, usually associated with administration without professional supervision. This can induce severe systemic toxicity. Diagnostic confirmation can be particularly challenging in cases presenting with nonspecific clinical signs or when conventional biological samples are unavailable. This case report describes the innovative use of earwax as a non-invasive biological matrix for toxicological confirmation in veterinary medicine. A 9-year-old male mixed-breed dog was admitted following a traumatic accident and subsequent administration by its owner of a human medication containing acetaminophen and codeine. Clinical evaluation revealed lethargy, hypersalivation, hyporexia, dehydration, and neurological abnormalities. Laboratory findings demonstrated neutrophilic leukocytosis and marked increases in hepatic enzyme activities, consistent with acute hepatocellular injury. Toxicological investigation using headspace gas chromatography-mass spectrometry detected acetaminophen-related signatures in an earwax sample, supporting suspected exposure to the drug. Intensive treatment was promptly initiated and included fluid therapy, antidotal treatment with N-acetylcysteine, opioid antagonism, analgesia, and supportive care. The patient showed progressive clinical improvement, with complete resolution of clinical signs and full recovery. This case highlights the significant risks of administering human medications to companion animals and underscores the need to improve owner awareness of self-medication practices. Furthermore, it demonstrates the diagnostic potential of earwax as a non-invasive biological matrix for toxicological confirmation, expanding the range of complementary diagnostic tools available for veterinary toxicology and supporting improved clinical decision-making in cases of suspected pharmaceutical intoxication.

PMID 42176063
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PubMedJournal of vascular and interventional radiology : JVIR2026-05-24

Diagnostic Performance of Ultrasound-Guided Omental Core Needle Biopsy: Impact of Coaxial Technique and Complementary Role of Ascitic Fluid Cytology in 463 Patients.

Kahriman Guven G, Onem Muhammed Musa MM, Karabiyik Ozgur O, Herdem Nevzat N et al.

To evaluate the safety and diagnostic performance of ultrasound (US)-guided omental core needle biopsy (CNB) using a composite reference standard, compare conventional and coaxial techniques, and assess the complementary role of ascitic fluid cytology. In this single-center retrospective cohort study, 463 patients (354 female, 109 male; median age, 64 years) with suspected omental disease who underwent US-guided omental CNB between January 2010 and December 2025 were included. Standard contraindications (eg, uncorrected coagulopathy) were respected. No additional exclusion criteria were applied. Biopsy results were correlated with surgical pathology or clinical-radiologic follow-up. Primary endpoints were diagnostic performance metrics and procedure-related adverse events. Subgroup comparisons were performed using Fisher's exact test, with p < 0.05 considered statistically significant. Technical success was achieved in 98.7% (457/463) of procedures, with no procedure-related adverse events. Overall, CNB demonstrated a sensitivity of 90.3%, specificity of 100%, and diagnostic accuracy of 93.3%. After repeat CNB in discordant cases, sensitivity increased to 95.0% and diagnostic accuracy to 96.5%. Coaxial CNB demonstrated higher sensitivity (92.7% vs 85.3%, p = 0.043) and diagnostic accuracy (95.0% vs 89.4%, p = 0.041) compared with conventional CNB. Ascitic fluid cytology showed sensitivity ranging from 65.1% to 76.7% depending on the interpretative threshold. US-guided omental CNB is a safe, minimally invasive approach, achieving high diagnostic accuracy with an excellent safety profile in an outpatient setting. The coaxial technique demonstrated higher diagnostic accuracy and sensitivity. Ascitic fluid cytology provided complementary diagnostic information, particularly in cases with false-negative biopsy results.

PMID 42177021
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PubMedClinical and experimental medicine2026-05-24

Plasma exosome lncRNA panel as a non-invasive biomarker for molecular diagnosis of systemic lupus erythematosus.

Li Zhi Z, Wan Shujun S, Li Xueqin X, Yang Hui H et al.

Exosome-derived long non-coding RNAs (lncRNAs) have emerged as promising diagnostic biomarkers in various diseases. However, their diagnostic potential in systemic lupus erythematosus (SLE) remains largely unexplored. This study aimed to characterize plasma exosomal lncRNA profiles and identify candidate lncRNAs with diagnostic and disease-monitoring potential in SLE. Plasma exosomes were isolated from SLE patients and healthy controls (HCs), followed by high-throughput sequencing to characterize exosomal lncRNA expression profiles. Differentially expressed lncRNAs were identified and subsequently validated using quantitative real-time PCR (qRT-PCR). Correlations between the validated exosomal lncRNAs and clinical indicators of SLE were assessed. Receiver operating characteristic (ROC) curve and multivariate logistic regression analyses were performed to evaluate the diagnostic performance of the identified lncRNAs. Three plasma-derived exosomal lncRNAs-ENSG00000229882, MIR4713HG, and LINC00620-were significantly upregulated in SLE patients compared with HCs. Logistic regression analysis identified MIR4713HG and LINC00620 as predictors of SLE. A combined diagnostic model incorporating these two lncRNAs demonstrated diagnostic capacity for distinguishing SLE patients from HCs, with an area under the curve (AUC) of 0.759. Notably, exosomal LINC00620 expression was significantly upregulated in patients with active SLE compared with those with inactive disease and showed a positive correlation with SLE Disease Activity Index 2000 (SLEDAI-2 K scores). Plasma exosomal ENSG00000229882, MIR4713HG, and LINC00620 were significantly upregulated in SLE, indicating their potential as non-invasive diagnostic biomarkers. Particularly, LINC00620 showed a positive correlation with disease activity, suggesting its clinical utility for both SLE diagnosis and disease monitoring.

PMID 42177684
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PubMedClinica chimica acta; international journal of clinical chemistry2026-05-24

JAK2 V617F as a diagnostic and prognostic biomarker in myeloproliferative neoplasms.

Bhat Asif Ahmad AA, Fuloria Shivkanya S, Thapa Riya R, Narain Kamal K et al.

Molecular analysis of BCR-ABL1-negative myeloproliferative neoplasms has shown a shared codon 617 substitution of JAK2 that leads to a constitutively active tyrosine kinase and a pathogenic lesion that unites all three polycythemia vera, essential thrombocythemia, and primary myelofibrosis. This mutation interferes with the autoinhibitory regulation and results in persistent downstream JAK-STAT signaling, and thereafter, myeloid, megakaryocytic, and inappropriate erythroid proliferation. JAK2 V617F has emerged as a major molecular biomarker in the diagnostic workup and classification of myeloproliferative neoplasms in laboratory medicine when used together with blood counts, bone marrow morphology, serum erythropoietin, and other molecular markers, such as CALR and MPL. Outside its diagnostic application, variant allele burden has also been linked to thrombosis, disease phenotype, clonal growth, fibrotic development, and survival but not uniformly across disease subtypes and clinical contexts. JAK2 V617F detection in laboratories has moved beyond traditional approaches based on PCR to sensitive quantitative technologies, such as digital PCR and next-generation sequencing-based technologies, making the standardization of assays, assurance of quality and more clinically integrated interpretation more important. In general, JAK2 V617F is an effective prognostic and diagnostic biomarker in myeloproliferative neoplasms. It can be further enhanced in diagnostic laboratory hematology with further optimization of the strategies of molecular testing, reporting systems, and multi-marker diagnostic algorithms.

PMID 42176929
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