FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer
| Autor: | Ping Zhao, Pengfei Song, Zhe Tang, Qi Liu, Yuzhuo Pan, Lijun Zhang, Whitney S. Helms, Gideon M. Blumenthal, Sean Khozin, Margaret E. Brower, Hong Zhao, Patricia Keegan, Karen Boyd, Emily Fox, R. Pazdur, Robert Justice, Shenghui Tang, Donghao Lu, Ali Al Hakim, Ruby Leong |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Aspartate transaminase Risk Assessment Gastroenterology Carcinoma Non-Small-Cell Lung Internal medicine Multicenter trial medicine Humans Anaplastic lymphoma kinase Anaplastic Lymphoma Kinase Sulfones Lung cancer Drug Approval Aged biology Ceritinib Crizotinib United States Food and Drug Administration business.industry Receptor Protein-Tyrosine Kinases Middle Aged medicine.disease United States Surgery Clinical trial Pyrimidines Oncology Alanine transaminase biology.protein Female business medicine.drug |
| Zdroj: | Clinical Cancer Research. 21:2436-2439 |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | On April 29, 2014, the FDA granted accelerated approval to ceritinib (ZYKADIA; Novartis Pharmaceuticals Corporation), a breakthrough therapy-designated drug, for the treatment of patients with anaplastic lymphoma kinase (ALK)–positive, metastatic non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The approval was based on a single-arm multicenter trial enrolling 163 patients with metastatic ALK-positive NSCLC who had disease progression on (91%) or intolerance to crizotinib. Patients received ceritinib at a starting dose of 750 mg orally once daily. The objective response rate (ORR) by a blinded independent review committee was 44% (95% CI, 36–52), and the median duration of response (DOR) was 7.1 months. The ORR by investigator assessment was similar. Safety was evaluated in 255 patients. The most common adverse reactions and laboratory abnormalities included diarrhea (86%), nausea (80%), increased alanine transaminase (80%), increased aspartate transaminase (75%), vomiting (60%), increased glucose (49%), and increased lipase (28%). Although 74% of patients required at least one dose reduction or interruption due to adverse reactions, the discontinuation rate due to adverse reactions was low (10%). With this safety profile, the benefit–risk analysis was considered favorable because of the clinically meaningful ORR and DOR. Clin Cancer Res; 21(11); 2436–9. ©2015 AACR. |
| Databáze: | OpenAIRE |
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