DOCSLIB.ORG

Moxetumomab Pasudotox in Heavily Pre‑Treated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long‑Term Follow‑Up from the Pivotal Trial Robert J

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Moxetumomab Pasudotox in Heavily Pre‑Treated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long‑Term Follow‑Up from the Pivotal Trial Robert J Kreitman et al. J Hematol Oncol (2021) 14:35 https://doi.org/10.1186/s13045-020-01004-y RESEARCH Open Access Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial Robert J. Kreitman1* , Claire Dearden2, Pier Luigi Zinzani3,4, Julio Delgado5, Tadeusz Robak6, Philipp D. le Coutre7, Bjørn T. Gjertsen8, Xavier Troussard9, Gail J. Roboz10, Lionel Karlin11, Douglas E. Gladstone12, Nataliya Kuptsova‑Clarkson13, Shiyao Liu14, Priti Patel14, Federico Rotolo15, Emmanuel Mitry15, Ira Pastan1 and Francis Giles16 on behalf of the Study 1053 investigators Results were presented in part at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, FL, December 7–10, 2019 Abstract Background: Moxetumomab pasudotox is a recombinant CD22‑targeting immunotoxin. Here, we present the long‑ term follow‑up analysis of the pivotal, multicenter, open‑label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL). Methods: Eligible patients had received 2 prior systemic therapies, including 2 purine nucleoside analogs (PNAs), or 1 PNA followed by rituximab or a BRAF≥ inhibitor. Patients received 40 µg/kg ≥moxetumomab pasudotox intrave‑ nously≥ on Days 1, 3, and 5 of each 28‑day cycle for up to six cycles. Disease response and minimal residual disease (MRD) status were determined by blinded independent central review. The primary endpoint was durable complete response (CR), defned as achieving CR with hematologic remission (HR, blood counts for CR) lasting > 180 days. Results: Eighty adult patients were treated with moxetumomab pasudotox and 63% completed six cycles. Patients had received a median of three lines of prior systemic therapy; 49% were PNA‑refractory, and 38% were unft for PNA retreatment. At a median follow‑up of 24.6 months, the durable CR rate (CR with HR > 180 days) was 36% (29 patients; 95% confdence interval: 26–48%); CR with HR 360 days was 33%, and overall CR was 41%. Twenty‑seven complete responders (82%) were MRD‑negative (34% of ≥all patients). CR lasting 60 months was 61%, and the median progres‑ sion‑free survival without the loss of HR was 71.7 months. Hemolytic uremic≥ and capillary leak syndromes were each reported in 10% of patients, and 5% had grade 3–4 events; these events were generally reversible. No treatment‑ related deaths≤ were reported. ≤ *Correspondence: [email protected] 1 Clinical Immunotherapy Section, Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892, USA Full list of author information is available at the end of the article © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Kreitman et al. J Hematol Oncol (2021) 14:35 Page 2 of 11 Conclusions: Moxetumomab pasudotox resulted in a high rate of durable responses and MRD negativity in heavily pre‑treated patients with HCL, with a manageable safety profle. Thus, it represents a new and viable treatment option for patients with R/R HCL, who currently lack adequate therapy. Trial registration: ClinicalTrials.gov identifer: NCT01829711; frst submitted: April 9, 2013. https:// clini caltr ials. gov/ ct2/ show/ NCT01 829711 Keywords: Hairy cell leukemia (HCL), B cell malignancy, Relapsed/refractory, CD22, Immunotoxin, Moxetumomab pasudotox, Minimal residual disease (MRD) Background therapies, are unable to completely eradicate MRD in all Hairy cell leukemia (HCL) is a rare mature B-cell malig- patients with R/R HCL [8–19]. nancy with high CD22 expression [1]. Te mainstay of In September 2018, moxetumomab pasudotox (CAT- therapy and recommended frst-line treatment is a purine 8015), a frst-in-class recombinant CD22-directed cyto- nucleoside analog (PNA) such as pentostatin or cladrib- toxin [28], was approved for the treatment of adult ine [2–4]. Although the majority of patients achieve long- patients with R/R HCL in the USA. Te pivotal mul- term remission with PNAs, eventual disease relapse and ticenter, open-label, single-arm trial (NCT01829711) diminishing clinical outcomes in later lines exemplify an evaluated the efcacy, safety, immunogenicity, and phar- important unmet need for therapies in relapsed/refrac- macokinetics of moxetumomab monotherapy in patients tory (R/R) HCL [4–7]. Novel targeted therapies such as with R/R HCL who had previously received ≥ 2 systemic rituximab (anti-CD20 monoclonal antibody), ibruti- therapies, including ≥ 1 PNA. To date, this is the larg- nib (Bruton tyrosine kinase inhibitor), and vemurafenib est study in heavily pre-treated HCL (N = 80). It was the (BRAF inhibitor) have demonstrated some efcacy in frst study to evaluate the efcacy and safety of a third- pre-treated patients but have not yet been rigorously line treatment with long-term follow-up and to report evaluated in robust studies with long-term follow-up, nor durable complete response (CR) as a primary endpoint. approved for HCL treatment [8–20]. Moreover, it was also one of few studies to prospectively Notably, the current treatment options are frequently assess MRD status after therapy in HCL. associated with safety and tolerability concerns. PNA At a median follow-up of 16.7 months (range: 2.1– therapy is immunosuppressive and thus associated with 48.8 months), the primary analysis showed a durable CR opportunistic infections and second malignancies in rate of 30% (24 patients), CR rate of 41% (33 patients), already vulnerable patients [2, 4, 5, 21]. Cladribine, in and MRD negativity in 82% (27 patients) of complete particular, is not recommended in those with an active responders. Furthermore, moxetumomab pasudotox infection, and patients must be closely monitored for demonstrated acceptable safety and manageable toler- symptoms of infection [2]. Rituximab can also lead to ability [29]. In this report, we present the fnal analy- severe infections, along with thrombocytopenia, and sis describing the long-term follow-up of efcacy and vemurafenib is associated with cutaneous conditions safety of moxetumomab pasudotox in patients with R/R including photosensitivity and skin papillomas [8, 9, 11, HCL, with a median follow-up of 24.6 months (range: 13, 15]. 1.2–71.7 months). One growing area of interest with relevance to the treatment of HCL is the concept of minimal residual Methods disease (MRD), defned as the detection of tumor cells Study design and patient eligibility below the sensitivity level of conventional cytomorphol- Tis multicenter, open-label, single-arm study enrolled ogy using techniques such as cytogenetics, fow cytom- patients from 32 centers across 14 countries. Adults etry, PCR, and high-throughput sequencing [22, 23]. (aged ≥ 18 years) with histologically confrmed HCL or MRD is widely used as a measure of tumor burden for variant HCL and an indication for therapy were eligible other hematologic malignancies, serving as a signifcant for this study. An indication for therapy was defned as prognostic factor for both acute lymphoblastic leukemia one or more of the following: neutrophils < 1.0 ­103/µL, 3 × and chronic myeloid leukemia and informing treatment platelets < 100 × ­10 /µL, hemoglobin < 10 g/dL, or symp- decisions [22, 24, 25]. In HCL, the implications of MRD tomatic splenomegaly. Patients must have been treated remain unclear; some studies report that MRD positivity with a minimum of two systemic therapies, including two after PNA therapy is predictive for disease relapse, sug- courses of a PNA, or one course of a PNA followed by gesting that MRD eradication may improve clinical out- rituximab or a BRAF inhibitor. Patients must not have comes [26, 27]. Current treatments, including targeted had prior treatment with moxetumomab pasudotox and Kreitman et al. J Hematol Oncol (2021) 14:35 Page 3 of 11 were required to have an Eastern Cooperative Oncology cells in the bone marrow by H&E staining. Additional Group (ECOG) performance status ≤ 2. Patients with details can be found in the study proto col. impaired renal or hepatic function, active second malig- Te secondary endpoints included CR rate, objective nancies requiring treatment, and uncontrolled intercur- response (OR) rate, time to and duration of CR and OR, rent illnesses such as an ongoing or active infection were MRD, progression-free survival (PFS) rates, safety/toler- excluded. Detailed inclusion and exclusion criteria can be ability, immunogenicity, and pharmacokinetics. found in the study proto col. MRD was locally assessed during treatment using Study treatment quantitative fow cytometric analysis of peripheral blood Moxetumomab pasudotox was administered at a dose samples or bone marrow aspirate, according to the insti- of 40 µg/kg by intravenous (i.v.) infusion over 30 min on tution’s protocols, and by immunohistochemistry (IHC) Days 1, 3, and 5 of a 28-day cycle for up to six cycles, or on the bone marrow biopsy tissue. Local study sites until documentation of MRD-negative CR, disease pro- received instructions on sample collection and submis- gression, initiation of an alternate therapy, or unaccepta- sion for analysis.
Load more

Recommended publications
  • Moxetumomab Pasudotox-Tdfk
    Wednesday, March 11, 2020 4:00pm Oklahoma Health Care Authority 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – March 11, 2020 DATE: February 24, 2020 NOTE: The DUR Board will meet at 4:00pm. The meeting will be held at 4345 N. Lincoln Blvd. Enclosed are the following items related to the March meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Update on Medication Coverage Authorization Unit/SoonerPsych Program Update – Appendix B Action Item – Vote to Prior Authorize Xcopri® (Cenobamate) – Appendix C Action Item – Vote to Prior Authorize Tosymra™ (Sumatriptan Nasal Spray), Reyvow™ (Lasmiditan), and Ubrelvy™ (Ubrogepant) – Appendix D Action Item – Vote to Prior Authorize Esperoct® [Antihemophilic Factor (Recombinant), Glycopegylated-exei] – Appendix E Action Item – Vote to Prior Authorize ProAir® Digihaler™ (Albuterol Sulfate Inhalation Powder) – Appendix F Action Item – Vote to Prior Authorize Evenity® (Romosozumab-aqqg) – Appendix G Action Item – Vote to Prior Authorize Asparlas™ (Calaspargase Pegol-mknl), Daurismo™ (Glasdegib), Idhifa® (Enasidenib), Lumoxiti® (Moxetumomab Pasudotox-tdfk), Tibsovo® (Ivosidenib), and Xospata® (Gilteritinib) – Appendix H Action Item – Vote to Prior Authorize Azedra® (Iobenguane I-131) – Appendix I Annual Review of Lymphoma Medications and 30-Day Notice to Prior Authorize Aliqopa™ (Copanlisib), Brukinsa™ (Zanubrutinib), Polivy™ (Polatuzumab Vedotin-piiq), and Ruxience™ (Rituximab-pvvr) – Appendix J Annual Review of Lutathera® (Lutetium Lu-177 Dotatate) and Vitrakvi® (Larotrectinib) – Appendix K Annual Review of Multiple Sclerosis (MS) Medications and 30-Day Notice to Prior Authorize Mayzent® (Siponimod), Mavenclad® (Cladribine), and Vumerity™ (Diroximel Fumarate) – Appendix L ORI-4403 • P.O.
    [Show full text]
  • Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (Enrollment Anticipated in 2018) Eligibility: • at Least 2 Prior Treatments, Including Purine Analog
    Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (enrollment anticipated in 2018) Eligibility: • At least 2 prior treatments, including purine analog. • Need for treatment (low blood counts or spleen pain) • No prior recombinant toxin • Hairy cell leukemia variant (HCLv) accepted Rationale • Moxetumomab pasudotox, formally called HA22 or CAT-8015, is a recombinant immunotoxin made out of 2 parts, an antibody part binding to CD22 on B-cells, and a toxin part (domain II and III) which kills the cell. • The toxin is extremely potent, only 1 molecule in the cytoplasm is enough to kill a cell. • HCL cells have much more CD22 than normal B-cells. • Normal B-cells rapidly regenerate from CD22-negative cells, but HCL cells may not return if eradicated. • ~50% complete remission (CR) rate at the highest dose level. (https://www.ncbi.nlm.nih.gov/pubmed/22355053). • Most of these complete remissions (CRs) had no minimal residual disease (MRD) and did not relapse. • Although severe toxicity was not seen, a low-grade hemolytic uremic syndrome, with temporary decrease in platelets and increase in creatinine, was seen in 2 of 49 patients. Design • 30 minute iv infusion every other day for 3 doses, repeat every 4 weeks for 6 cycles. • Patients are then followed without treatment. Cladribine With Simultaneous or Delayed Rituximab for early HCL Cladribine (daily x5) Rituximab weekly x8 (CDAR) |||||||| |||||||| Cladribine + immediate Rituximab vs > 6 mo |||||||| Cladribine + delayed Rituximab |||||||| • Eligibility: 0-1 prior purine analog, or HCL variant (HCLv), and need for treatment (i.e. low blood counts) • Minimal residual disease (MRD) after purine analog (cladribine or pentostatin) may cause relapse.
    [Show full text]
  • Lumoxiti™ (Moxetumomab Pasudotox-Tdfk)
    Lumoxiti™ (moxetumomab pasudotox-tdfk) (Intravenous) -E- Document Number: IC-0474 Last Review Date: 12/01/2020 Date of Origin: 07/01/2019 Dates Reviewed: 07/2019, 12/2019, 12/2020 I. Length of Authorization Coverage is provided for six months (6 cycles) and may not be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: − Lumoxiti 1 mg SDV: 15 vials per 28 day cycle B. Max Units (per dose and over time) [HCPCS Unit]: • 500 billable units on days 1, 3 and 5 of a 28-day cycle III. Initial Approval Criteria 1-3 Coverage is provided in the following conditions: • Patient is at least 18 years or older; AND • Patient does not have severe renal impairment defined as CrCl ≤ 29 mL/min; AND • Patient does not have prior history of severe thrombotic microangiopathy (TMA) or hemolytic uremic syndrome (HUS); AND • Must be used as a single agent; AND Hairy Cell Leukemia (HCL) † Ф 1-4 • Patient has a confirmed diagnosis of Hairy Cell Leukemia or a HCL variant; AND • Patient must have relapsed or refractory disease; AND • Patient has previously failed at least TWO prior systemic therapies consisting of one of the following: o Failure to two courses of purine analog therapy (e.g., cladribine, pentostatin, etc.); OR o Failure to at least one purine analog therapy AND one course of rituximab or a BRAF- inhibitor (e.g., vemurafenib, etc.) Moda Health Plan, Inc. Medical Necessity Criteria Page 1/6 Preferred therapies and recommendations are determined by review of clinical evidence. NCCN category of recommendation is taken into account as a component of this review.
    [Show full text]
  • Calquence Phase III ELEVATE-TN Trial Met Primary
    Calquence Phase III ELEVATE-TN trial met primary This announcement contains inside information 6 June 2019 07:00 BST Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia Calquence alone or in combination significantly increased the time patients lived without disease progression AstraZeneca today announced positive results from the Phase III ELEVATE-TN trial of Calquence(acalabrutinib) in patients with previously- untreated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1 This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May. The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated astatistically-significant and clinically- meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. The trial also met a key secondary endpoint showing Calquence monotherapy achieved a statistically-significant and clinically-meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen. The safety and tolerability of Calquence was consistent with its established profile. José Baselga, Executive Vice President, Oncology R&D said: "These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year." AstraZeneca plans to present detailed results from ELEVATE-TN at a forthcoming medical meeting. Additionally, AstraZeneca will present full results from the Phase III ASCEND clinical trial in relapsed or refractory CLL as a late-breaking abstract at the upcoming European Hematology Association (EHA) Annual Congress on 16 June 2019 (Abstract #LB2606).
    [Show full text]
  • Hairy Cell Leukemia
    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Hairy Cell Leukemia Version 2.2021 — March 11, 2021 NCCN.org Continue Version 2.2021, 03/11/21 © 2021 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. Printed by Ma Qingzhong on 3/15/2021 10:54:42 PM. For personal use only. Not approved for distribution. Copyright © 2021 National Comprehensive Cancer Network, Inc., All Rights Reserved. NCCN Guidelines Index NCCN Guidelines Version 2.2021 Table of Contents Hairy Cell Leukemia Discussion *William G. Wierda, MD, PhD/Chair † ‡ *Steve E. Coutre, MD ‡ Thomas J. Kipps, MD, PhD ‡ The University of Texas Stanford Cancer Institute UC San Diego Moores Cancer Center MD Anderson Cancer Center Randall S. Davis, MD ‡ Shuo Ma, MD, PhD † *John C. Byrd, MD/Vice-Chair ‡ Þ ξ O'Neal Comprehensive Cancer Center at UAB Robert H. Lurie Comprehensive Cancer The Ohio State University Comprehensive Center of Northwestern University Herbert Eradat, MD, MS ‡ Cancer Center - James Cancer Hospital UCLA Jonsson Comprehensive Cancer Center Anthony Mato, MD ‡ and Solove Research Institute Memorial Sloan Kettering Cancer Center Christopher D. Fletcher, MD ‡ Jeremy S. Abramson, MD, MMSc † ‡ University of Wisconsin Claudio Mosse, MD, PhD ≠ Massachusetts General Carbone Cancer Center Vanderbilt-Ingram Cancer Center Hospital Cancer Center Armin Ghobadi, MD ‡ Þ ξ Stephen Schuster, MD † ‡ Syed F. Bilgrami, MD ‡ Siteman Cancer
    [Show full text]
  • Medical Oncology Program Prior Review Code List Effective January 1, 2020
    1 Blue Medicare HMO/ PPO and Experience Health Medicare Advantage SM (HMO) Medical Oncology Program Prior Review Code List Effective January 1, 2020 Unlisted and Miscellaneous health service codes should only be used if a specific code has not been established by the American Medical Association. Notice Date: The listed date is when the notice of the existing code was added. Effective Date: The listed date is when the code will require prior authorization for correct claims processing. If there is no date in this field, the requirement is in effect. Ineffective Date: The listed date is when the code became invalid. *Prior approval is required for all drugs listed below regardless of the HCPCS code submitted on the claim. The requirement is based on the drug itself—not the code chosen to submit on the claim. Ineffective Date CPT Service Description Effective Notice Date Date J0881 INJECTION, DARBEPOETIN ALFA, 1 MCG (NON-ESRD 4/1/2017 12/30/2016 USE) J0885 INJECTION, EPOETIN ALFA, (NON-ESRD USE), 1000 4/1/2017 12/30/2016 UNITS J0897 INJECTION, DENOSUMAB, 1 MG FOR ONCOLOGY 4/1/2017 12/30/2016 INDICATIONS ONLY J0185 Injection, aprepitant, 1 mg (Cinvanti TM ) 1/1/2020 10/1/2019 January 2020 2 J1442 INJECTION, FILGRASTIM (G-CSF), EXCLUDES 4/1/2017 12/30/2016 BIOSIMILARS, 1 MICROGRAM J1453 INJECTION, FOSAPREPITANT, 1 MG 4/1/2017 12/30/2016 J1447 INJECTION, TBO-FILGRASTIM, 1 MICROGRAM 4/1/2017 12/30/2016 J1454 Injection, fosnetupitant 235 mg and palonosetron 0.25 mg 1/1/2020 10/1/2019 [AKYNZEO®] J1627 INJECTION, GRANISETRON, EXTENDED-RELEASE,
    [Show full text]
  • Health Partners Plan - Medical Oncology List
    Health Partners Plan - Medical Oncology List Primary Alt Descriptions HCPCS Codes HPP Administration Technique Drug Class 5-Fluorouracil 5FU, Adrucil J9190 Y INJECTABLE Primary Ado-Trastuzumab Emtansine Kadcyla J9354 Y INJECTABLE Primary Aldesleukin Proleukin, Interleukin-2 J9015 Y INJECTABLE Primary Arsenic Trioxide Trisenox J9017 Y INJECTABLE Primary Asparaginase Erwinaze J9019 Y INJECTABLE Primary Atezolizumab Tecentriq J9022 Y INJECTABLE Primary Avelumab Bavencio J9023 Y INJECTABLE Primary Azacitidine Vidaza J9025 Y INJECTABLE Primary BCG TheraCys, Tice J9031 Y INJECTABLE Primary Belinostat Beleodaq J9032 Y INJECTABLE Primary Bendamustine Bendamustine (Not otherwise specified) C9399 Y INJECTABLE Primary Bendamustine Bendamustine (Not otherwise specified) J9999 Y INJECTABLE Primary Bendamustine Treanda J9033 Y INJECTABLE Primary Bendamustine HCL Belrapzo C9042 Y INJECTABLE Primary Bendamustine HCL Bendeka J9034 Y INJECTABLE Primary Bevacizumab Avastin J9035 Y INJECTABLE Primary Bevacizumab-awwb (not currently Mvasi Q5107 Y INJECTABLE Primary available on the market) Bleomycin Blenoxane J9040 Y INJECTABLE Primary Blinatumomab Blincyto J9039 Y INJECTABLE Primary Bortezomib Velcade J9041 Y INJECTABLE Primary Bortezomib Bortezomib (not otherwise specified) J9044 Y INJECTABLE Primary Brentuximab Vedotin Adcetris J9042 Y INJECTABLE Primary Cabazitaxel Jevtana J9043 Y INJECTABLE Primary Calaspargase pegol-mknl Asparlas J3490 Y INJECTABLE Primary Calaspargase pegol-mknl Asparlas J3590 Y INJECTABLE Primary Carboplatin Paraplatin J9045 Y INJECTABLE
    [Show full text]
  • 2.03.502 Monoclonal Antibodies for the Treatment of Lymphoma
    MEDICAL POLICY – 2.03.502 Monoclonal Antibodies for the Treatment of Lymphoma BCBSA Ref. Policy: 2.03.05 Effective Date: Sept. 1, 2021 RELATED MEDICAL POLICIES: Last Revised: Aug. 3, 2021 5.01.549 Off-Label Use of Drugs and Biologic Agents Replaces: N/A 5.01.550 Pharmacotherapy of Arthropathies 5.01.556 Rituximab: Non-oncologic and Miscellaneous Uses 8.01.533 Radioimmunotherapy in the Treatment of Non-Hodgkin Lymphoma Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction An antibody is a blood protein. When the immune system detects an unhealthy cell, antibodies attach themselves to a molecule known as an antigen on that unhealthy cell. The antibody then acts as flag for other immune system cells, causing those other immune system cells to swarm to the area and fight the unhealthy cell. Cancer cells can evade the immune system by reproducing very quickly, avoiding detection, or completely blocking the immune system. Monoclonal antibodies are drugs that work with the body’s natural immune response. Monoclonal antibodies are produced in a laboratory and made to specifically attach to the antigens which are typically found in high numbers on cancer cells. This policy describes when treatment with monoclonal antibodies may be approved to treat lymphoma. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals.
    [Show full text]
  • Medical Policy Update: November 2018
    November 2018 In This Issue Coverage Criteria Revised for Histone Deacetylase (HDAC) Inhibitors ..................................................... 2 Coverage Criteria Established for Mogamulizumab-kpkc (Poteligeo) ........................................................ 4 Polymerized Sucralfate Malate Paste (ProThelial) Considered Experimental/Investigational .................... 5 REMINDER: Molecular and Genomic Testing .......................................................................................... 6 Contents .......................................................................................................................................................... 11 Policy Coverage Criteria Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies Highmark Blue Shield has revised coverage criteria for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies per approved Food and Drug Administration (FDA) indications and National Comprehensive Cancer Network (NCCN) guidelines. The updated criteria will include cemiplimab (Libtayo®) for advanced or metastatic urothelial carcinoma or metastatic non-small cell lung cancer. The updated criteria will also include FDA approved indications for Atezolizumab (Tecentriq®), Nivolumab (Opdivo®) and Pembrolizumab (Keytruda®). The Medical Policy will apply to both professional provider and facility claims. The effective date is November 12, 2018. Please refer to Medical Policy I-120, Programmed Death Receptor (PD-1)/ Programmed
    [Show full text]
  • Clinical Criteria Updates for Specialty Pharmacy
    MAINE Provider Communications Clinical criteria updates for specialty pharmacy Published: Nov 1, 2019 - Products & Programs / Pharmacy The following clinical criteria documents were endorsed at the August 16, 2019 clinical criteria meeting. To access the clinical criteria information please click here. If you do not have access to the internet, you may request a hard copy of any updated policy by contacting the Provider Call Center. Revised clinical criteria effective September 23, 2019 (The following clinical criteria was revised to expand medical necessity indications or criteria.) ING-CC-0011 Ocrevus (ocrelizumab) ING-CC-0014 Beta Interferons and Glatiramer Acetate for Treatment of Multiple Sclerosis ING-CC-0027 Denosumab Agents ING-CC-0028 Benlysta (belimumab) ING-CC-0029 Dupixent (dupilumab) ING-CC-0030 Implantable and ER Buprenorphine Containing Agents ING-CC-0038 Human Parathyroid Hormone Agents ING-CC-0041 Complement Inhibitors ING-CC-0075 Rituximab Agents for Non-Oncology Indications ING-CC-0082 Onpattro (patisiran) ING-CC-0105 Vectibix (panitumumab) ING-CC-0114 Jevtana (cabazitaxel) ING-CC-0124 Keytruda (pembrolizumab) ING-CC-0127 Darzalex (daratumumab) ING-CC-0128 Tecentriq (atezolizumab) ING-CC-0134 Provenge (sipuleucel-T) Revised clinical criteria effective September 23, 2019 (The following clinical criteria were reviewed and may have word changes or clarifications, but had no significant changes to the medical necessity indications or criteria.) ING-CC-0004 H.P. Acthar Gel (repository corticotropin injection) ING-CC-0008
    [Show full text]
  • 2.03.502 Monoclonal Antibodies for the Treatment of Lymphoma
    MEDICAL POLICY – 2.03.502 Monoclonal Antibodies for the Treatment of Lymphoma BCBSA Ref. Policy: 2.03.05 Effective Date: Sept. 1, 2021 RELATED MEDICAL POLICIES: Last Revised: Aug. 3, 2021 5.01.549 Off-Label Use of Drugs and Biologic Agents Replaces: N/A 5.01.550 Pharmacotherapy of Arthropathies 5.01.556 Rituximab: Non-oncologic and Miscellaneous Uses 8.01.533 Radioimmunotherapy in the Treatment of Non-Hodgkin Lymphoma Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction An antibody is a blood protein. When the immune system detects an unhealthy cell, antibodies attach themselves to a molecule known as an antigen on that unhealthy cell. The antibody then acts as flag for other immune system cells, causing those other immune system cells to swarm to the area and fight the unhealthy cell. Cancer cells can evade the immune system by reproducing very quickly, avoiding detection, or completely blocking the immune system. Monoclonal antibodies are drugs that work with the body’s natural immune response. Monoclonal antibodies are produced in a laboratory and made to specifically attach to the antigens which are typically found in high numbers on cancer cells. This policy describes when treatment with monoclonal antibodies may be approved to treat lymphoma. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals.
    [Show full text]
  • Injectable and Health Care Administered Oncology Medical Drug Criteria Through Preferred (Optional)
    Injectable and Health Care Administered Oncology Medical Drug Program Summary For patients with late stage metastatic disease (Stage IV), please refer to MP 2.373 Step Therapy Treatment in Cancer, Including Treatments for Stage Four, Advanced Metastatic Cancer and Severe Related Health Conditions for additional guidance *No Preferred Strategy The clinical rationale section is inf ormational, please refer to the medical drug criteria section for agents requiring medical drug review. FDA APPROVED INDICATIONS AND DOSAGE1-65 Agent Indication Dosage Abraxane® [paclitaxel ● Metastatic breast cancer Metastatic breast cancer: (protein bound)] af ter failure of combination 260 mg/m2 intravenously chemotherapy or relapse over 30 minutes, every 3 Injectable suspension within 6 months of adjuvant weeks chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated ● Locally advanced or NSCLC: metastatic Non-Small Cell 100 mg/m2 intravenously Lung Cancer (NSCLC) as over 30 minutes on Days 1, f irst-line treatment in 8, and 15 of each 21-day combination with cycle. Administer carboplatin, in patients who carboplatin on Day 1 of each are not candidates for 21-day cycle immediately curative surgery or radiation af ter Abraxane therapy ● Metastatic adenocarcinoma Metastatic of the pancreas as first-line adenocarcinoma of the treatment in combination pancreas: with gemcitabine 125 mg/m2 intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. Administer gemcitabine immediately af ter paclitaxel (protein bound) on days 1, 8, and 15 of each 28-day cycle Adcetris® (brentuximab Treatment of adult patients vedotin) with: Injection for intravenous ● Previously untreated Stage Previously untreated use III or IV classical Hodgkin Stage III or IV cHL: 1.2 lymphoma (cHL) in mg/kg up to a maximum of combination with 120 mg every 2 weeks for a doxorubicin, vinblastine, and maximum of 12 doses dacarbazine CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 1 of 46 © Copyright Prime Therapeutics LLC.
    [Show full text]