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Oncology Oral, Other Therapeutic Class Review (TCR) July 3, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. July 2020 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010–2020 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer FDA-Approved Indications avapritinib Blueprint . Treatment of adults with unresectable or metastatic gastrointestinal stromal (Ayvakit™)1 tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations; patients should be selected for treatment with avapritinib based on confirmation of the presence of a PDGFRA exon 18 mutation cabozantinib Exelixis . Treatment of progressive, metastatic medullary thyroid cancer (Cometriq®)2 erdafitinib Janssen . Treatment of adult patients with locally advanced or metastatic urothelial (Balversa™)3 carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)-3 or FGFR2 genetic alterations and progressed during or following ≥ 1 line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; patients should be selected for therapy based on an FDA-approved companion diagnostic test*,† larotrectinib Loxo-Bayer, . Treatment of adult and pediatric patients with solid tumors that have a sulfate Bayer neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known (Vitrakvi®)4 acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment; patients should be selected for treatment based on the NTRK gene fusion being present in tumor specimens† lomustine NextSource . Brain tumors, primary and metastatic, following appropriate surgical and/or (Gleostine®)5 Biotechnology radiotherapeutic procedures . Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy niraparib Tesaro . Maintenance treatment of adult patients with advanced epithelial ovarian, (Zejula®)6 fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy . Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy . Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥ 3 prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: 1) a deleterious or suspected deleterious BRCA mutation or 2) genomic instability and who have progressed > 6 months after response to the last platinum-based chemotherapy; patients should be selected for treatment based on an FDA-approved companion diagnostic test* * Use of FDA-approved companion diagnostics can be found at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm † This approval was an Accelerated Approval based on objective or overall response rate, duration of response, and/or tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Oncology Oral, Other Therapeutic Class Review – July 2020 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer FDA-Approved Indications olaparib AstraZeneca . Maintenance treatment of adult patients with deleterious or suspected (Lynparza®)7 deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; select patients for treatment based on an FDA-approved companion diagnostic* . In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: 1) a deleterious or suspected deleterious BRCA mutation, and/or 2) genomic instability; patients should be selected for treatment based on an FDA-approved companion diagnostic test* . Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy . Treatment of adult patients with deleterious or suspected deleterious germline gBRCAm advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy; select patients for treatment based on an FDA- approved companion diagnostic* . Patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy; patients should be selected for treatment based on the FDA-approved companion diagnostic* . Maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on ≥ 16 weeks of a first-line platinum-based chemotherapy regimen; patients should be selected for treatment based on an FDA-approved companion diagnostic test* . Treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone; patients should be selected for treatment based on an FDA-approved companion diagnostic test* pemigatinib Incyte . Treatment of adults with previously treated, unresectable locally advanced or (Pemazyre™)8 metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test† pexidartinib Daiichi Sankyo . Treatment of adult patients with symptomatic tenosynovial giant cell tumor (Turalio™)9 (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery * Use of FDA-approved companion diagnostics can be found at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm † This approval was an Accelerated Approval based on objective or overall response rate, duration of response, and/or tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Oncology Oral, Other Therapeutic Class Review – July 2020 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer FDA-Approved Indications regorafenib Bayer . Treatment of metastatic colorectal cancer (CRC) patients who have been (Stivarga®)10 previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy . Treatment of patients with locally advanced, unresectable, or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate . Treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib ripretinib Deciphera . Treatment of adults with advanced GIST who have received prior treatment (Qinlock™)11 with ≥ 3 kinase inhibitors, including imatinib rucaparib
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