FDA approval: Ceritinib for the treatment of Metastatic Anaplastic lymphoma Kinase-positive non-small cell lung cancer

Clinical Cancer Research

Volumn 21, Issue 11, 2015, Pages 2436-2439

  Khozin, Sean ^a   Blumenthal, Gideon M ^a   Zhang, Lijun ^a   Tang, Shenghui ^a   Brower, Margaret ^a   Fox, Emily ^a   Helms, Whitney ^a   Leong, Ruby ^a   Song, Pengfei ^a   Pan, Yuzhuo ^a   Liu, Qi ^a   Zhao, Ping ^a   Zhao, Hong ^a   Lu, Donghao ^a   Tang, Zhe ^a   Hakim, Ali Al ^a   Boyd, Karen ^a   Keegan, Patricia ^a   Justice, Robert ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ANAPLASTIC LYMPHOMA KINASE; ASPARTATE AMINOTRANSFERASE; CERITINIB; CRIZOTINIB; GLUCOSE; KETOCONAZOLE; RIFAMPICIN; TRIACYLGLYCEROL LIPASE; PROTEIN TYROSINE KINASE; PYRIMIDINE DERIVATIVE; SULFONE;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ADVERSE DRUG REACTION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; BRADYCARDIA; CANCER GROWTH; CONSTIPATION; CONVULSION; DECREASED APPETITE; DECREASED HEMOGLOBIN; DECREASED PHOSPHATE; DEHYDRATION; DIARRHEA; DRUG APPROVAL; DRUG DESIGN; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART TAMPONADE; HUMAN; HYPERGLYCEMIA; HYPERTRANSAMINASEMIA; HYPOPHOSPHATEMIA; INCREASED ALANINE AMINOTRANSFERASE; INCREASED ALANINE TRANSAMINASE; INCREASED ASPARTATE AMINOTRANSFERASE; INCREASED ASPARTATE TRANSAMINASE; INCREASED CREATININE; INCREASED GLUCOSE; INCREASED LIPASE; INTERSTITIAL LUNG DISEASE; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; METASTATIC NON SMALL CELL LUNG CANCER; MULTICENTER STUDY; NAUSEA; NEUROPATHY; NON SMALL CELL LUNG CANCER; PNEUMONIA; PNEUMOTHORAX; PRIORITY JOURNAL; QT PROLONGATION; RECOMMENDED DRUG DOSE; RESPIRATORY FAILURE; REVIEW; RISK BENEFIT ANALYSIS; SEPSIS; STOMACH HEMORRHAGE; VISUAL DISORDER; VOMITING; AGED; CARCINOMA, NON-SMALL-CELL LUNG; CLASSIFICATION; CLINICAL TRIAL; GENETICS; MIDDLE AGED; PATHOLOGY; RISK ASSESSMENT; UNITED STATES;

AGED; CARCINOMA, NON-SMALL-CELL LUNG; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; PYRIMIDINES; RECEPTOR PROTEIN-TYROSINE KINASES; RISK ASSESSMENT; SULFONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84937116601     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-3157     Document Type: Review

References (24)

1. Pao W, Girard N. New driver mutations in non-small-cell lung cancer. Lancet Oncol 2011;12:175-80.
2. Oxnard GR, Binder A, Jänne PA. New targetable oncogenes in non-smallcell lung cancer. J Clin Oncol 2013;31:1097-104.
3. Scagliotti G, Stahel RA, Rosell R, Thatcher N, Soria JC. ALK translocation and crizotinib in non-small cell lung cancer: An evolving paradigm in oncology drug development. Eur J Cancer 2012;48:961-73.
4. Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007;448:561-6.
5. Malik SM, Maher VE, Bijwaard KE, Becker RL, Zhang L, Tang SW, et al. U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res 2014; 20:2029-34.
6. Lovly CM, Shaw AT. Molecular pathways: resistance to kinase inhibitors and implications for therapeutic strategies. Clin Cancer Res 2014;20: 2249-56.
7. Doebele RC, Pilling AB, Aisner DL, Kutateladze TG, Le AT, Weickhardt AJ, et al. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res 2012;18:1472-82.
8. Katayama R, Shaw AT, Khan TM, Mino-Kenudson M, Solomon BJ, Halmos B, et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers. Sci Transl Med 2012;4:1-12.
9. Friboulet L, Li N, Katayama R, Lee CC, Gainor JF, Crystal AS. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov 2014;4:662-73.
10. Drugs@FDA [database on the internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2014 [cited 2015 Mar 2]. Pharmacology review(s); (143 p.). Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/205755Orig1s000PharmR.pdf. Files updated daily.
11. Drugs@FDA [database on the internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2014 [cited 2015 Jan 26]. Clinical pharmacology and biopharmaceutics review(s); (137 p.). Available from: http://www. accessdata.fda.gov/drugsatfda-docs/nda/2014/205755Orig1s000Clin-PharmR.pdf. Files updated daily.
12. Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014; 370:1189-97.
13. Drugs@FDA [database on the internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2014 [cited 2015 Jan 27]. Medical review; (82 p.). Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/205755Orig1s000MedR.pdf. Files updated daily.
14. Babb J, Rogatko A, Zacks S. Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat Med 1998;17:1103-20.
15. Neuenschwander B, BransonM, Gsponer T. Critical aspects of the Bayesian approach to phase I cancer trials. Stat Med 2008;27:2420-39.
16. Guidance for industry: drug-induced liver injury: premarketing clinical evaluation [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2009 [cited 2015 Jan 26]. Available from: http://www. fda.gov/downloads/Drugs/.../Guidances/UCM174090.pdf.
17. Sørensen JB, Hansen HH, Hansen M, Dombernowsky P. Brain metastases in adenocarcinoma of the lung: frequency, risk groups, and prognosis. J Clin Oncol 1988;6:1474-80.
18. Gainor JF, Ou SH, Logan J, Borges LF, Shaw AT. The central nervous system as a sanctuary site in ALK-positive non-small-cell lung cancer. J Thorac Oncol 2013;8:1570-3.
19. Costa DB, Kobayashi S, Pandya SS, Yeo WL, Shen Z, Tan W, et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 2011;29:443-5.
20. Shaw AT, Yeap BY, Solomon BJ, Riely GJ, Gainor J, Engelman JA, et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: A retrospective analysis. Lancet Oncol 2011;12:1004-12.
21. Guidance for industry: collection of race and ethnicity data in clinical trials [PDF on the Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2005 [cited 2015 Jan 26]. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf.
22. Seto T, Kiura K, Nishio M, Nakagawa K, Maemondo M, Inoue A, et al. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): A single-Arm, open-label, phase 1-2 study. Lancet Oncol 2013;14:590-8.
23. Iacono D, Chiari R, Metro G, Bennati C, Bellezza G, Cenci M, et al. Future options for ALK-positive non-small cell lung cancer. Lung Cancer 2015;87:211-9.
24. Blumenthal GM, Karuri SW, Zhang H, Zhang L, Khozin S, Kazandjian D, et al. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol 2015;33:1008-14.