scholarly journals Editorial: Global Regulatory Initiatives Deliver Accelerated Approval of the First Bispecific Therapeutic Monoclonal Antibody for Advanced Non-Small Cell Lung Cancer (NSCLC)

2021 ◽  
Vol 27 ◽  
Author(s):  
Dinah V. Parums
Author(s):  
Hirofumi Chiba ◽  
Nobuyoshi Hayashi ◽  
Koji Kuronuma ◽  
Mitsuo Otsuka ◽  
Masanori Shiratori ◽  
...  

2019 ◽  
Vol 53 (6) ◽  
pp. 621-626 ◽  
Author(s):  
Sara A. Spencer ◽  
Angela C. Riley ◽  
Adia Matthew ◽  
Anthony J. Di Pasqua

Objective: We review here the pharmacology, pharmacokinetics, efficacy, safety, dosage and administration, potential drug-drug interactions and place in therapy of brigatinib for abnormal anaplastic lymphoma kinase (ALK) specific non–small-cell lung cancer (NSCLC). Data Sources: A literature search using PubMed was conducted using the terms brigatinib and ALK positive NSCLC from January 2013 to November 2018. Study Selection and Data Extraction: All English-language articles evaluating brigatinib were analyzed for this review. Data Synthesis: Brigatinib was granted approval for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. It is administered at a dose of 90 mg orally once daily for the first 7 days then, if tolerated, increased to a dose of 180 mg orally once daily. Common adverse effects include nausea, fatigue, diarrhea, increased creatine phosphokinase levels, headache, dyspnea, and hypertension. Serious treatment-emergent adverse effects were pulmonary related. Relevance to Patient Care and Clinical Practice: This article discusses the clinical trials that led to the accelerated approval of brigatinib for its ability to overcome crizotinib-resistant mutations and for its increased central nervous system penetration properties. Conclusion: Brigatinib was granted accelerated approval for the treatment of patients with metastatic ALK+ NSCLC who have progressed on or are intolerant to crizotinib. In a subset of NSCLC patients, brigatinib increases survival for approximately 1 year; however, side effects were detected.


2007 ◽  
Vol 56 (10) ◽  
pp. 1637-1644 ◽  
Author(s):  
Martin Sebastian ◽  
Bernward Passlick ◽  
Hilke Friccius-Quecke ◽  
Michael Jäger ◽  
Horst Lindhofer ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21181-21181
Author(s):  
G. B. Malika ◽  
K. Bouzid ◽  
G. R Baba-Ahmed ◽  
T Makhloufi ◽  
S Taright ◽  
...  

21181 Background: The aim of the study was to assess the relation between expression of EGFR, p53, cell proliferation defined by the monoclonal antibody Ki67 and survival of patients with non-small cell lung cancer stage III and IV. Methods: 80 patients were included in this study (male 72 / female 8); the median follow up was 15 months. All tumor samples were formalin-fixed and paraffin-embedded. The expression of p53, EGFR and Ki 67 were assessed with the use of immunohistochemically (IHC). P53 was assessed in 66 cases, EGFR in 73 cases and cell proliferation defined by the monoclonal antibody Ki67 in 63 cases. Results: The expression of p53 was positive in 20 % of cases, EGFR was positive in 58,7 % of cases and cell proliferation in 40 % of cases. Survival was estimated from the date of first cycle of chemotherapy using median survival and the Kaplan-Meier survival analysis method. Conclusion: At this time of the study, there was no relation between expression of p53, EGFR, cell proliferation defined by ki67 and survival. Larger and longer follow-up studies may be needed to determine the prognostic role of expression of those factors in NSCLC. [Table: see text] No significant financial relationships to disclose.


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