Vizimpro (dacomitinib)
/ SFJ Pharma, Pfizer
- LARVOL DELTA
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June 29, 2025
The interplay between mechanisms of resistance and therapeutic targets: identifying novel treatments for drug-resistant BRAFV600E pediatric high-grade glioma
(EACR 2025)
- "Similarly, dabrafenib (BRAFi)-treated animals orthotopically administered with the vemurafenib-resistant culture had significantly reduced survival compared to treated animals administered with the matched parental cells (65 days vs 79 days)...Repotrectinib (NTRK2/SRCi) and dacomitinib (EGFRi) were found to display potent synergistic activity when used in combination with vemurafenib (BRAFi) against both vemurafenib-resistant BRAFV600E pHGG cells and matched parental cells in vitro... This study has demonstrated that analyzing tumor mechanisms is a powerful tool for identifying effective therapies in treatment-refractory tumors. Using an omics-based approach in BRAFV600E pHGG, we have identified novel drivers of drug resistance, key therapeutic targets and several promising therapeutic options."
Clinical • Brain Cancer • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor • EGFR • NTRK2
June 27, 2025
A Review on Anticancer Potential and Structure-Activity Relationships (SAR) of Novel EGFR/HER2 Inhibitors.
(PubMed, Curr Top Med Chem)
- "EGFR/HER2 dual inhibitors, approved by the US FDA (Food and Drug Administration), include lapatinib, afatinib, neratinib, dacomitinib, etc., but these drugs lack selectivity, specificity, and undesirable adverse effects. The present manuscript focuses on the identification and development of therapeutic molecules that can inhibit the target proteins EGFR/HER2 and can further be used for the treatment of breast and lung malignancies. It also highlights the development of EGFR/HER2 dual inhibitors that belong to different structural classes like pyrimidine, quinazoline, pyridine, benzimidazole, and quinoline etc. Various parameters, such as Structure-Activity Relationships (SAR), clinical trials data, patent filed, and the molecular docking study of the most potent compounds provide a valuable asset for further designing and discovering new EGFR/HER2 dual inhibitors with potential therapeutic significances for cancer treatment."
Journal • Breast Cancer • Lung Cancer • Oncology • EGFR • ERBB3 • ERBB4 • HER-2
June 11, 2025
Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers
(clinicaltrials.gov)
- P2 | N=24 | Active, not recruiting | Sponsor: National Cancer Centre, Singapore | Recruiting ➔ Active, not recruiting | N=104 ➔ 24 | Trial completion date: Jun 2028 ➔ May 2027 | Trial primary completion date: Jul 2025 ➔ Apr 2027
Biomarker • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
June 09, 2025
Cost-utility analysis of osimertinib and dacomitinib in the first-line treatment of advanced non-small cell lung cancer with EGFR mutation.
(PubMed, Expert Rev Pharmacoecon Outcomes Res)
- "The incremental cost-effectiveness ratio is 436,203 CNY, which is higher than three times China's per capita GDP. Under the threshold of three times China's per capita GDP, osimertinib appears not to be cost-effective compared to dacomitinib."
HEOR • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
June 06, 2025
Acetaldehyde dehydrogenase 1A1 upregulation drives dacomitinib-induced skin toxicity through mitochondrial dysfunction and keratinocyte apoptosis.
(PubMed, Cell Signal)
- "Furthermore, silibinin was shown to mitigate dacomitinib-induced cutaneous toxicity by reducing ALDH1A1. Overall, this study highlights the critical role of ALDH1A1 in drug-induced cutaneous toxicity and its potential as an interventional target."
Journal • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALDH1A1 • HER-2
June 05, 2025
A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
(clinicaltrials.gov)
- P=N/A | N=29 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=100 ➔ 29 | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025
Enrollment change • Enrollment closed • HEOR • Real-world evidence • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
June 02, 2025
Orally effective FDA-approved protein kinase targeted covalent inhibitors (TCIs): A 2025 update.
(PubMed, Pharmacol Res)
- "The clinical efficacy of ibrutinib, a Bruton tyrosine kinase blocker, in the treatment of mantle cell lymphoma following its 2013 approval helped to overcome a general bias against the development of irreversible drug inhibitors. Other approved targeted covalent inhibitors include acalabrutinib and zanubrutinib, which also block Bruton tyrosine kinase. Afatinib, dacomitinib, lazertinib, mobocertinib, and osimertinib inhibit members of the epidermal growth factor receptor family (ErbB1/2/3/4) and are used in the treatment of non-small cell lung cancers. Neratinib inhibits ErbB2 and is used in the management of ErbB2/HER2-positive breast cancer. Futibatinib blocks the fibroblast growth factor receptor family and is prescribed for the treatment of cholangiocarcinoma while ritlecitinib, which inhibits JAK3, is used in the management of alopecia areata. The eleven drugs considered in this review have a common mechanism of action involving the addition of a protein cysteine..."
FDA event • Journal • Review • Alopecia • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BTK • EGFR • FGFR
May 28, 2025
In silico discovery of multi-target small molecules and efficient siRNA design to overcome drug resistance in breast cancer via local therapy.
(PubMed, J Mol Graph Model)
- "Based on DFT results, the golden ligand showed higher stability and lower reactivity compared to control ligands such as aromatase, tamoxifen, and dacomitinib, potentially leading to reduced off-target interactions and a more favorable safety profile. The integration of these data underscores the therapeutic potential of SCHEMBL7562664 as a multi-target agent for breast cancer, with promising pharmacokinetic properties that can be optimized for local treatment by incorporation into a 3D scaffold."
Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PARP10 • PKMYT1 • STING
May 22, 2025
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
(clinicaltrials.gov)
- P=N/A | N=40 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed
Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
March 26, 2025
Over 200! The largest BaF3-EGFR engineering cell lines collection, a useful platform for novel drug discovery
(AACR 2025)
- "Recognizing EGFR as a driver gene has accelerated the development of targeted anticancer therapies, such as monoclonal anti-EGFR antibodies (cetuximab, panitumumab) and small molecule receptor tyrosine kinase inhibitors (TKIs). The first generation of EGFR TKIs, like gefitinib and erlotinib, specifically target mutations such as L858R and exon 19 deletions. To address resistance to these early inhibitors, second-generation EGFR TKIs (afatinib, dacomitinib) were developed...Osimertinib, a third-generation TKI, was approved for use in EGFR-mutated NSCLC following the failure of first- and second-generation TKIs, although the EGFR C797S mutation limits its effectiveness. Fourth-generation EGFR TKIs, including BLU-945 and BBT-176, are under clinical evaluation but are not yet approved.We have created more than 200 Ba/F3-EGFR engineered cell lines, making this the largest in vitro and in vivo platform for drug discovery with the widest range of mutant cells. These cell lines..."
Preclinical • Brain Cancer • Breast Cancer • Colon Cancer • Colorectal Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • EGFR • EPGN • ERBB3 • ERBB4 • HBEGF • HER-2 • TGFA
March 25, 2025
Analytical Approaches to Estimate Medication Persistence From Electronic Health Record Data: A Study of Tyrosine Kinase Inhibitors in Patients With Epidermal Growth Factor Receptor-Positive Advanced Non-Small Cell Lung Cancer
(ISPOR 2025)
- "This study compared approaches for estimating the persistence of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI), including erlotinib, gefitinib, dacomitinib, afatinib, osimertinib, and lazertinib, among patients with EGFR-positive advanced non-small cell lung cancer (advNSCLC). The non-TTE approach estimated higher EGFR TKI persistence than the TTE approach at all timepoints. The TTE approach accounts for censoring and estimates cumulative persistence, whereas the non-TTE approach provides a point-in-time snapshot. The TTE approach may also provide insights into other real-world outcomes, such as real-world treatment duration."
Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
May 11, 2025
Efficacy and safety of dacomitinib in treatment-naïve patients with advanced NSCLC and brain metastasis: a multicenter cohort study.
(PubMed, Oncologist)
- "Dacomitinib showed promising efficacy and a manageable safety profile for advanced NSCLC with brain metastasis harboring EGFR mutation in the first-line treatment."
Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
March 26, 2025
ERBB4 upregulation in a taxol-resistant triple-negative breast cancer cell line
(AACR 2025)
- "Treatment of the cells with ERBB inhibitors, sfatinib, allitinib, or PF299804, in sub-lethal concentration only induced a small additive effect on paclitaxel cytotoxicity in MDA-MB-231 cells, but dramatically enhanced paclitaxel cytotoxicity in T50RN cells. These results suggest that ERBB4 may play a critical role in paclitaxel resistance in T50RN cells. Further elucidation of how ERBB4 is induced in T50RN cells and how ERBB4 regulates cell resistance might provide leads to overcome paclitaxel resistance."
Preclinical • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • ERBB4 • HER-2
April 29, 2025
Inter-Ethnic Differences in the Efficacy and Safety of Tyrosine Kinase Inhibitors Used in Oncology: Insights From Phase 3 Clinical Trials.
(PubMed, Clin Transl Sci)
- "Twelve (16%) of the analyses investigating the efficacy of afatinib, brigatinib, dacomitinib, gilteritinib, lorlatinib, neratinib, osimertinib, or pazopanib were assessed to report population differences in PFS and/or OS...The majority of clinical trials noted no clinically remarkable differences in safety between subpopulations; however, for brigatinib, crizotinib, pazopanib, and sunitinib, distinct patterns of adverse events were reported in the Asian and non-Asian subgroups. The underrepresentation of specific subpopulations, the grouping together of results of diverse subpopulations, as well as inconsistencies in the definition and reporting of participant ethnicity/ancestry are barriers to the meaningful exploration of inter-ethnic differences in TKI response. Therefore, further insight into the associations between ethnicity/ancestry and TKI response will require an increase in the diversity of clinical trial participants and appropriate analysis and reporting of..."
Journal • P3 data • Review • Oncology
April 08, 2025
A Structural Insight Into Two Important ErbB Receptors (EGFR and HER2) and Their Relevance to Non-Small Cell Lung Cancer.
(PubMed, Arch Pharm (Weinheim))
- "To develop treatment for EGFR-related NSCLC, several tyrosine kinase inhibitors (TKIs) were designed: gefitinib, erlotinib, as first-generation; neratinib, dacomitinib as second-generation; osimertinib, lazertinib as third-generation, as examples. Although structures obtained so far for the EGFR family provide meaningful insights into the mechanisms, the quality and the quantity of the EGFR family structures are insufficient to elucidate the complete structures and functions to overcome NSCLC. This review evaluates the structures of EGFR-HER2 and investigates their relation to NSCLC."
Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR • HER-2
March 26, 2025
First-in-human studies of VRN110755 in NSCLC patients with EGFR mutations: Safety, pharmacokinetics, and early efficacy assessment
(AACR 2025)
- "Tumor assessments showed >40% tumor shrinkage in a patient with a C797S mutation, who had progressed after dacomitinib and osimertinib, after 4 weeks of 40 mg treatment. Additionally, another patient with a Del19 mutation, who had progressed after afatinib and platimum chemotherapy, demonstrated >20 % tumor shrinkage after 3 weeks of 80 mg treatment.These findings strongly support the translation of preclinical data into early clinical outcomes for VRN110755. In conclusion, the preclinical and early clinical outcomes of VRN110755 highlight its potential as a promising therapeutic option that can address unmet medical needs in advanced EGFR mutated NSCLC, including resistance to current standard-of-care therapies and progression with BM/LM."
Clinical • P1 data • PK/PD data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
March 26, 2025
Machine-learning-driven optimization of kinase inhibitors to overcome CNS efflux and target breast cancer brain metastases
(AACR 2025)
- "Despite the improvements in HER2 targeted therapy to rapidly target BCBM, tucatinib and other quinazoline HER2 inhibitors (dacomitinib and gefitinib) possess poor CNS penetration due to P-gp and BCRP efflux. Our results suggest that structural optimization to modulate the physicochemical properties of small molecules is key to identifying potential drug candidates for targeting BCBM. In vivo studies using animal models will be conducted to validate these findings."
Machine learning • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor
March 26, 2025
Aurora kinase A inhibition overcomes tolerance to panHER inhibitors in HPV positive HNSCC
(AACR 2025)
- "We demonstrate that although panHER inhibitors afatinib and dacomitinib more effectively inhibit growth of HPV+ HNSCC cells than do erlotinib or cetuximab, adaptive signaling through the AURKA/PLK1 axis mediates resistance to panHER inhibitors...Indeed, cell viability experiments and clonogenic survival assays demonstrate strong synergy between panHER and AURKA inhibitors, confirmed in xenografted tumor models treated with the second generation AURKA inhibitor VIC-1911 and dacomitinib...In contrast, addition of AURKA inhibition upregulated PLK1 and pPLK1 and cell death markers. These findings indicate that combination therapy with AURKA inhibition will mitigate the adaptability to EGFR and panHER inhibitors previously described for HPV+ HNSCC."
Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • AURKA • ERBB3 • PLK1
April 04, 2025
A Bayesian network meta-analysis of EGFR-tyrosine kinase inhibitor treatments in patients with EGFR mutation-positive non-small cell lung cancer.
(PubMed, Cancer Pathog Ther)
- "We conducted a network meta-analysis of randomized controlled trials comparing osimertinib, lazertinib, aumolertinib, befotertinib, furmonertinib, dacomitinib, afatinib, erlotinib, gefitinib, icotinib, and chemotherapy. Osimertinib is the first choice of treatment with considerable efficacy and safety for EGFR mutation-positive NSCLC. The treatments associated with the best PFS in patients with exon 19 deletions and Leu858Arg mutations were furmonertinib and lazertinib, respectively."
Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
April 16, 2025
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
(clinicaltrials.gov)
- P=N/A | N=40 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Aug 2026 ➔ Apr 2025 | Trial primary completion date: Aug 2026 ➔ Apr 2025
Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
April 11, 2025
Identification and Characterization of Dacomitinib Metabolites in Rats by Liquid Chromatography Combined With Q-Exactive-Orbitrap High Resolution Mass Spectrometry.
(PubMed, Biomed Chromatogr)
- "Phase II biotransformation pathways included GSH conjugation and N-acetyl-cysteine conjugation. These findings enhance understanding of dacomitinib's metabolic fate, providing critical insights into its elimination mechanisms, and supporting subsequent evaluation of therapeutic efficacy and safety profiles."
Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
April 10, 2025
Neoadjuvant Targeted Therapy with Dacomitinib in a Stage IIIA Non-Small-Cell Lung Cancer Patient Harboring EGFR G719X: A Case Report.
(PubMed, Onco Targets Ther)
- "Here, we firstly report that a stage IIIA lung adenocarcinoma patient benefited from chemotherapy and dacomitinib as neoadjuvant targeted therapy based on EGFR G719X mutation, achieving a pathological downstaging and the chance of radical surgical resection. Our case describes dacomitinib use as neoadjuvant targeted therapy for EGFR positive advanced NSCLC and highlights the application of molecular testing for the better treatment decision making."
Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
March 31, 2025
Development of indole hybrids for potential lung cancer treatment - part II.
(PubMed, Future Med Chem)
- "Moreover, indole hybrids osimertinib, mobocertinib, cediranib, and vizimpro are currently applied in clinics for lung cancer therapy, demonstrating that indole hybrids are valuable scaffolds in the treatment and eradication of lung cancer. This review provides a comprehensive overview of the evolving landscape of indole hybrids with the in vitro and in vivo efficacy against lung cancer, and the structure-activity relationships as well as mechanisms of action are also discussed, covering articles published from 2021 onward."
Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
March 26, 2025
Adverse event profiles of EGFR-TKI: network meta-analysis and disproportionality analysis of the FAERS database.
(PubMed, Front Pharmacol)
- "Afatinib showed highest toxicity; Icotinib was safest...Gefitinib had the strongest signal for interstitial lung diseases; Erlotinib for anorexia...Drugs varied in AE profiles, mostly mild, but Osimertinib and Dacomitinib were associated with more severe events. Osimertinib carried a high cardiac risk, delayed onset, and high mortality. Thus, comprehensive patient assessment and close monitoring are crucial with EGFR-TKI use."
Adverse events • Journal • Retrospective data • Anorexia • Cardiovascular • Heart Failure • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Pulmonary Disease • Respiratory Diseases • Thrombocytopenia
March 12, 2025
Case Report: Grade 4 pneumonitis occurred after thoracic radiotherapy and dacomitinib in a patient with lung adenocarcinoma.
(PubMed, Front Oncol)
- "Osimertinib combined with chest radiotherapy has a high incidence of pneumonia, dacomitinib is widely used in clinical practice, but there are no studies reporting the pulmonary safety of dacomitinib in combinating with radiotherapy. The concurrent administration of dacomitinib and RT carries the risk of inducing serious pneumonia. This case highlights the potential risk of severe pneumonia associated with this combination therapy, emphasizing the need for further research to clarify its safety and develop effective management strategies."
Journal • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor
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