Zykadia (Ceritinib)

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Zykadia® (ceritinib) – New formulation approval • On March 18, 2019, the FDA approved Novartis’ Zykadia (ceritinib) tablets, for the treatment of adults with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase- positive as detected by an FDA-approved test. — Zykadia is also available as capsules for the same indication. • The approval of Zykadia tablets was based on studies conducted with Zykadia capsules. • Warnings and precautions of Zykadia include gastrointestinal adverse reactions, hepatotoxicity, interstitial lung disease/pneumonitis, QT interval prolongation, hyperglycemia, bradycardia, pancreatitis, and embryo-fetal toxicity. • The most common adverse reactions (≥ 25%) with the use of Zykadia 450 mg with food were diarrhea, nausea, abdominal pain vomiting, and fatigue; and with Zykadia 750 mg under fasted conditions were diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and weight loss. • The recommended dose of Zykadia tablets or capsules is 450 mg orally once daily with food until disease progression or unacceptable toxicity. • Novartis’ launch plans for Zykadia tablets are pending. Zykadia tablets will be available in a strength of 150 mg. optumrx.com OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum® company — a leading provider of integrated health services. Learn more at optum.com. All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx. RxNews® is published by the OptumRx Clinical Services Department. ©2019 Optum, Inc. All rights reserved. .

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Clinical Response of the Novel Activating ALK-I1171T
http://www.diva-portal.org This is the published version of a paper published in Cold Spring Harbor Molecular Case Studies. Citation for the original published paper (version of record): Guan, J., Fransson, S., Siaw, J T., Treis, D., Van den Eynden, J. et al. (2018) Clinical response of the novel activating ALK-I1171T mutation in neuroblastoma o the ALK inhibitor ceritinib Cold Spring Harbor Molecular Case Studies, 4(4): a002550 https://doi.org/10.1101/mcs.a002550 Access to the published version may require subscription. N.B. When citing this work, cite the original published paper. Permanent link to this version: http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-154087 Downloaded from molecularcasestudies.cshlp.org on December 12, 2018 - Published by Cold Spring Harbor Laboratory Press COLD SPRING HARBOR Molecular Case Studies | RESEARCH ARTICLE Clinical response of the novel activating ALK-I1171T mutation in neuroblastoma to the ALK inhibitor ceritinib Jikui Guan,1,2,12 Susanne Fransson,3,12 Joachim Tetteh Siaw,1,12 Diana Treis,4,12 Jimmy Van den Eynden,1 Damini Chand,1 Ganesh Umapathy,1 Kristina Ruuth,5 Petter Svenberg,4 Sandra Wessman,6,7 Alia Shamikh,6,7 Hans Jacobsson,8 Lena Gordon,9 Jakob Stenman,10 Pär-Johan Svensson,10 Magnus Hansson,11 Erik Larsson,1 Tommy Martinsson,3 Ruth H. Palmer,1 Per Kogner,6,7 and Bengt Hallberg1 1Department of Medical Biochemistry and Cell Biology, Institute of Biomedicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg 40530, Sweden; 2Children’s Hospital Affiliated to Zhengzhou University,
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ZYKADIA (Ceritinib) RATIONALE for INCLUSION in PA PROGRAM
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Clinical Response of the Novel Activating ALK-I1171T Mutation In
Downloaded from molecularcasestudies.cshlp.org on October 9, 2021 - Published by Cold Spring Harbor Laboratory Press 1 Clinical response of the novel activating ALK-I1171T mutation in 2 neuroblastoma to the ALK inhibitor ceritinib. 3 4 Jikui Guan1*, Susanne Fransson2*, Joachim Tetteh Siaw1*, Diana Treis4*, Jimmy Van den 5 Eynden1, Damini Chand1, Ganesh Umapathy1, Kristina Ruuth9, Petter Svenberg4, Sandra 6 Wessman5, Alia Shamikh5, Hans Jacobsson6, Lena Gordon7, Jakob Stenman8, Pär-Johan 7 Svensson8, Magnus Hansson3, Erik Larsson1, Tommy Martinsson2#, Ruth H. Palmer1#, Per 8 Kogner5#, Bengt Hallberg1#. 9 10 Departments of 1Medical Biochemistry and Cell Biology, 2Pathology and Genetics, 3Pediatrics and 11 Pathology, Institute of Biomedicine, The Sahlgrenska Academy, University of Gothenburg, 12 Gothenburg, Sweden, 4Childhood Cancer Research Unit, Department of Women’s and Children’s 13 Health, and Pediatric Oncology Program Karolinska University Hospital, 5Department of Oncology- 14 Pathology, Karolinska Institutet, and Dept. of Clinical Pathology, Karolinska University Hospital, 15 6Department of Radiology, Karolinska University Hospital, 7Dept. of Pediatric Radiology, Astrid 16 Lindgren Children’s Hospital, Karolinska University Hospital, 8Department of Pediatric Surgery, 17 Astrid Lindgren Children’s Hospital, Karolinska University Hospital, Stockholm, Sweden and 18 9Institute of Molecular Biology, Umeå University, Umeå, Sweden. 19 20 21 Running title: Clinical response to ceritinib in ALK-positive neuroblastoma. 22 23 #Correspondence:
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First-Line Treatment Options for Patients with Stage IV Non-Small Cell Lung Cancer with Driver Alterations
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ALK Tyrosine Kinase Inhibitors, 5.01.538
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Zykadia) for Metastatic Non-Small Cell Lung Cancer
pan-Canadian Oncology Drug Review Final Clinical Guidance Report Ceritinib (Zykadia) for Metastatic Non-Small Cell Lung Cancer December 3, 2015 DISCLAIMER Not a Substitute for Professional Advice This report is primarily intended to help Canadian health systems leaders and policymakers make well-informed decisions and thereby improve the quality of health care services. While patients and others may use this report, they are made available for informational and educational purposes only. This report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision making process, or as a substitute for professional medical advice. Liability pCODR does not assume any legal liability or responsibility for the accuracy, completeness or usefulness of any information, drugs, therapies, treatments, products, processes, or services disclosed. The information is provided "as is" and you are urged to verify it for yourself and consult with medical experts before you rely on it. You shall not hold pCODR responsible for how you use any information provided in this report. Reports generated by pCODR are composed of interpretation, analysis, and opinion on the basis of information provided by pharmaceutical manufacturers, tumour groups, and other sources. pCODR is not responsible for the use of such interpretation, analysis, and opinion. Pursuant to the foundational documents of pCODR, any findings provided by pCODR are not binding on any organizations, including funding bodies. pCODR hereby disclaims any and all liability for the use of any reports generated by pCODR (for greater certainty, "use" includes but is not limited to a decision by a funding body or other organization to follow or ignore any interpretation, analysis, or opinion provided in a pCODR report) FUNDING The pan-Canadian Oncology Drug Review is funded collectively by the provinces and territories, with the exception of Quebec, which does not participate in pCODR at this time.
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Rapidly Changing Treatment Algorithms for Metastatic Nonsquamous Non-Small-Cell Lung Cancer
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205755Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 SUMMARY REVIEW Division Director Summary Review 1. Introduction Ceritinib is an inhibitor of the ALK receptor tyrosine kinase. Genetic rearrangements (translocations) in the ALK gene, most commonly EML4 translocation, result in expression of a fusion protein with ligand-independent, constitutive activation. In vitro studies demonstrate that ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signaling proteins; ceritinib also inhibits proliferation of ALK-dependent cancer cell lines in vitro and in tumor xenograft models. The safety and efficacy of ceritinib is primarily based on data from Study CLDK378X2101, an open-label, multi-stage, dose-escalation and multiple parallel cohort, activity-estimating trial investigating the safety, pharmacokinetics, and anti-tumor activity of ceritinib in patients with tumors confirmed to have genetic abnormalities in ALK or who had previously received an ALK inhibitor (Arms A and B of the dose-cohort expansion). The efficacy and safety of ceritinib was established in an open-label, single-arm study enrolling 163 patients with metastatic ALK-positive NSCLC whose cancer had progressed while receiving or were intolerant to crizotinib. All patients received ceritinib 750 mg once daily. The objective response rate (ORR) in this population, as determined by a Blinded Independent Central Review Committee (BIRC) was 44% (95% CI: 36, 52) and the median duration of responses was 7.1 months (95% CI: 5.6, NE). These results are similar to those reported by clinical investigator assessment. In addition, these results are supported by anti- tumor activity observed in patients who had never received crizotinib.
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Study Protocol & Schedule of Activities
CLINICAL STUDY PROTOCOL Title: A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson’s Disease (PD) Acronym: NILO-PD IND#: 134973 Version: 4 Clinical Phase: IIa Sponsor: Northwestern University Feinberg School of Medicine Principal Investigator: Tanya Simuni, MD Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center Northwestern University Feinberg School of Medicine Department of Neurology, Abbott Hall, 11th Floor 710 North Lake Shore Drive Chicago, Illinois 60611 Funding: Michael J. Fox Foundation for Parkinson’s Research Supported by: Parkinson Study Group Clinical Coordination Center: Clinical Trials Coordinating Center, Rochester, NY Data Coordination Center: Clinical Trials Coordinating Center, Rochester, NY Biostatistics Coordination Center: Clinical Trials Statistical & Data Management Center, Iowa City, Iowa CONFIDENTIAL This document is a confidential communication. The recipient agrees that no information contained herein will be published or disclosed without written approval. This document may be disclosed to appropriate institutional review boards, independent ethics committees, or duly authorized representatives of the U.S. Food & Drug Administration or other regulatory authorities as appropriate; under the condition that confidentiality is requested. Protocol Title: A Randomized, Double-Blind, Placebo-Controlled,
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Lung Cancer Agents – Unified Formulary
bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Pharmacy Policy Lung Cancer Agents – Unified Formulary Policy Number: 9.712 Version Number: 1.1 Version Effective Date: 3/3/2021 Product Applicability All Plan+ Products Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth- MCO MassHealth- ACO Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options Note: Disclaimer and audit information is located at the end of this document. Prior Authorization Policy Reference Table: Drugs that require PA No PA Alecensa® (alectinib) Alunbrig® (brigatinib) Gilotrif® (afatinib) Iressa® (gefitinib) Lorbrena® (lorlatinib) Tabrecta® (capmatinib) Tagrisso® (osimertinib) Tarceva® (erlotinib) * Vizimpro® (dacomitinib) Xalkori® (crizotinib) Zykadia® (ceritinib) *A-rated generic available. Both brand and A-rated generic require PA. + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Lung Cancer Agents 1 of 7 Procedure: Approval Diagnosis: Advanced or metastatic non-small cell lung cancer (All agents) Advanced or metastatic pancreatic cancer (erlotinib) Stage IIB to IIIA NSCLC (Tagrisso®) Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis* Alecensa® (alectinib) 2. Prescriber is an oncologist 3. Appropriate dosing Zykadia® (ceritinib) 4. Cancer is anaplastic lymphoma kinase (ALK)-positive (Documentation must be provided on the PA request or in attached medical records) 5. ONE of the following: a. If the request is for Alecensa® (alectinib), quantity requested is ≤8 units/day b.
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Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase
Author Manuscript Published OnlineFirst on March 9, 2015; DOI: 10.1158/1078-0432.CCR-14-3157 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase- Positive Non-Small Cell Lung Cancer Sean Khozin1, Gideon M Blumenthal1, Lijun Zhang2, Shenghui Tang2, Margaret Brower1, Emily Fox1, Whitney Helms1, Ruby Leong3, Pengfei Song3, Yuzhuo Pan3, Qi Liu3 Ping Zhao3, Hong Zhao3, Donghao Lu4, Zhe Tang4, Ali Al Hakim4, Karen Boyd1, Patricia Keegan1, Robert Justice1, and Richard Pazdur1 1Office of Hematology and Oncology Products, FDA, Silver Spring, Maryland 2Office of Biostatistics, FDA, Silver Spring, Maryland 3Office of Translational Sciences, FDA, Silver Spring, Maryland 4Office of New Drug Quality Assessment, FDA, Silver Spring, Maryland Note: This is a U.S. Government work. There are no restrictions on its use. S. Khozin, G.M Blumenthal, and R. Pazdur share senior authorship. Corresponding Author: Sean Khozin, Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 2322, Silver Spring, MD 20993-0002. Phone: 301-796-1435; Fax: 301-796-9909; E-mail: [email protected] Running Title: FDA Approval of Ceritinib for ALK-Positive NSCLC Disclosure of Potential Conflicts of Interest No potential conflicts of interest were disclosed. Page 1 of 15 Downloaded from clincancerres.aacrjournals.org on September 28, 2021. © 2015 American Association for Cancer Research. Author Manuscript Published OnlineFirst on March 9, 2015; DOI: 10.1158/1078-0432.CCR-14-3157 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited.
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