Banner Health Network Medical Oncology Code List
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Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
Dinutuximab for the Treatment of Pediatric Patients with High-Risk Neuroblastoma
Expert Review of Clinical Pharmacology ISSN: 1751-2433 (Print) 1751-2441 (Online) Journal homepage: http://www.tandfonline.com/loi/ierj20 Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma Jaume Mora To cite this article: Jaume Mora (2016): Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma, Expert Review of Clinical Pharmacology, DOI: 10.1586/17512433.2016.1160775 To link to this article: http://dx.doi.org/10.1586/17512433.2016.1160775 Accepted author version posted online: 02 Mar 2016. Published online: 21 Mar 2016. Submit your article to this journal Article views: 21 View related articles View Crossmark data Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierj20 Download by: [Hospital Sant Joan de Deu], [Jaume Mora] Date: 30 March 2016, At: 23:12 EXPERT REVIEW OF CLINICAL PHARMACOLOGY, 2016 http://dx.doi.org/10.1586/17512433.2016.1160775 DRUG PROFILE Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma Jaume Mora Department of Pediatric Onco-Hematology and Developmental Tumor Biology Laboratory, Hospital Sant Joan de Déu, Passeig Sant Joan de Déu, Barcelona, Spain ABSTRACT ARTICLE HISTORY Neuroblastoma (NB) is the most common extra cranial solid tumor of childhood, with 60% of patients Received 14 December 2015 presenting with high risk (HR) NB by means of clinical, pathological and biological features. The 5-year Accepted 29 February 2016 survival rate for HR-NB remains below 40%, with the majority of patients suffering relapse from Published online chemorefractory tumor. Immunotherapy is the main strategy against minimal residual disease and 21 March 2016 clinical experience has mostly focused on monoclonal antibodies (MoAb) against the glycolipid dis- KEYWORDS ialoganglioside GD2. -
Australian Public Assessment for Polatuzumab Vedotin
Australian Public Assessment Report for Polatuzumab vedotin Proprietary Product Name: Polivy Sponsor: Roche Products Pty Ltd December 2019 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs • An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications. • An AusPAR is a static document; it provides information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. -
Pharmacokinetics of Polatuzumab Vedotin in Combination with R/G‑CHP in Patients with B‑Cell Non‑Hodgkin Lymphoma
Cancer Chemotherapy and Pharmacology (2020) 85:831–842 https://doi.org/10.1007/s00280-020-04054-8 ORIGINAL ARTICLE Pharmacokinetics of polatuzumab vedotin in combination with R/G‑CHP in patients with B‑cell non‑Hodgkin lymphoma Colby S. Shemesh1 · Priya Agarwal1 · Tong Lu1 · Calvin Lee2 · Randall C. Dere3 · Xiaobin Li1 · Chunze Li1 · Jin Y. Jin1 · Sandhya Girish1 · Dale Miles1 · Dan Lu1 Received: 4 October 2019 / Accepted: 3 March 2020 / Published online: 28 March 2020 © The Author(s) 2020 Abstract Purpose The phase Ib/II open-label study (NCT01992653) evaluated the antibody-drug conjugate polatuzumab vedotin (pola) plus rituximab/obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (R/G-CHP) as frst-line therapy for B-cell non-Hodgkin lymphoma (B-NHL). We report the pharmacokinetics (PK) and drug–drug interaction (DDI) for pola. Methods Six or eight cycles of pola 1.0–1.8 mg/kg were administered intravenously every 3 weeks (q3w) with R/G-CHP. Exposures of pola [including antibody-conjugated monomethyl auristatin E (acMMAE) and unconjugated MMAE] and R/G-CHP were assessed by non-compartmental analysis and/or descriptive statistics with cross-cycle comparisons to cycle 1 and/or after multiple cycles. Pola was evaluated as a potential victim and perpetrator of a PK drug–drug interaction with R/G-CHP. Population PK (popPK) analysis assessed the impact of prior treatment status (naïve vs. relapsed/refractory) on pola PK. Results Pola PK was similar between treatment arms and independent of line of therapy. Pola PK was dose proportional from 1.0 to 1.8 mg/kg with R/G-CHP. -
Antibody–Drug Conjugates
Published OnlineFirst April 12, 2019; DOI: 10.1158/1078-0432.CCR-19-0272 Review Clinical Cancer Research Antibody–Drug Conjugates: Future Directions in Clinical and Translational Strategies to Improve the Therapeutic Index Steven Coats1, Marna Williams1, Benjamin Kebble1, Rakesh Dixit1, Leo Tseng1, Nai-Shun Yao1, David A. Tice1, and Jean-Charles Soria1,2 Abstract Since the first approval of gemtuzumab ozogamicin nism of activity of the cytotoxic warhead. However, the (Mylotarg; Pfizer; CD33 targeted), two additional antibody– enthusiasm to develop ADCs has not been dampened; drug conjugates (ADC), brentuximab vedotin (Adcetris; Seat- approximately 80 ADCs are in clinical development in tle Genetics, Inc.; CD30 targeted) and inotuzumab ozogami- nearly 600 clinical trials, and 2 to 3 novel ADCs are likely cin (Besponsa; Pfizer; CD22 targeted), have been approved for to be approved within the next few years. While the hematologic cancers and 1 ADC, trastuzumab emtansine promise of a more targeted chemotherapy with less tox- (Kadcyla; Genentech; HER2 targeted), has been approved to icity has not yet been realized with ADCs, improvements treat breast cancer. Despite a clear clinical benefit being dem- in technology combined with a wealth of clinical data are onstrated for all 4 approved ADCs, the toxicity profiles are helping to shape the future development of ADCs. In this comparable with those of standard-of-care chemotherapeu- review, we discuss the clinical and translational strategies tics, with dose-limiting toxicities associated with the mecha- associated with improving the therapeutic index for ADCs. Introduction in antibody, linker, and warhead technologies in significant depth (2, 3, 8, 9). Antibody–drug conjugates (ADC) were initially designed to leverage the exquisite specificity of antibodies to deliver targeted potent chemotherapeutic agents with the intention of improving Overview of ADCs in Clinical Development the therapeutic index (the ratio between the toxic dose and the Four ADCs have been approved over the last 20 years (Fig. -
Federal Register Notice 5-1-2020 Pdf Icon[PDF – 358
Federal Register / Vol. 85, No. 85 / Friday, May 1, 2020 / Notices 25439 confidential by the respondent (5 U.S.C. schedules. Other than examination DEPARTMENT OF HEALTH AND 552(b)(4)). reports, it provides the only financial HUMAN SERVICES Current actions: The Board has data available for these corporations. temporarily revised the instructions to The Federal Reserve is solely Centers for Disease Control and the FR Y–9C report to accurately reflect responsible for authorizing, supervising, Prevention the revised definition of ‘‘savings and assigning ratings to Edges. The [CDC–2020–0046; NIOSH–233–C] deposits’’ in accordance with the Federal Reserve uses the data collected amendments to Regulation D in the on the FR 2886b to identify present and Hazardous Drugs: Draft NIOSH List of interim final rule published on April 28, potential problems and monitor and Hazardous Drugs in Healthcare 2020 (85 FR 23445). Specifically, the develop a better understanding of Settings, 2020; Procedures; and Risk Board has temporarily revised the activities within the industry. Management Information instructions on the FR Y–9C, Schedule HC–E, items 1(b), 1(c), 2(c) and glossary Legal authorization and AGENCY: Centers for Disease Control and content to remove the transfer or confidentiality: Sections 25 and 25A of Prevention, HHS. withdrawal limit. As a result of the the Federal Reserve Act authorize the ACTION: Notice and request for comment. revision, if a depository institution Federal Reserve to collect the FR 2886b chooses to suspend enforcement of the (12 U.S.C. 602, 625). The obligation to SUMMARY: The National Institute for six transfer limit on a ‘‘savings deposit,’’ report this information is mandatory. -
Polatuzumab Vedotin + Obinutuzumab + Lenalidomide in Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of a Phase Ib/II Trial
Polatuzumab vedotin + obinutuzumab + lenalidomide in patients with relapsed/refractory follicular lymphoma: interim analysis of a phase Ib/II trial Catherine Diefenbach,1 Brad Kahl,2 Lalita Banerjee,3 Andrew McMillan,4 Rod Ramchandren,5,6 Fiona Miall,7 Javier Briones,8 Raul Cordoba,9 Eva Maria Gonzalez-Barca,10 Carlos Panizo,11 Jamie Hirata,12 Naomi Chang,13 Lisa Musick,12 Pau Abrisqueta14 1Perlmutter Cancer Center at NYU Langone Health, New York, NY, USA; 2Division of Oncology, Washington University, St Louis, MO, USA; 3Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Kent, UK; 4Centre for Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK; 5Division of Oncology, University of Tennessee, Knoxville, TN, USA; 6Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA; 7Department of Haematology, University Hospitals of Leicester NHS Trust, Leicester, UK; 8Department of Hematology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; 9Fundación Jiménez Díaz, Madrid, Spain; 10Institut Català D'Oncologia, Barcelona, Spain; 11Clínica Universidad de Navarra, Pamplona, Spain; 12Genentech, Inc., South San Francisco, CA, USA; 13F. Hoffmann-La Roche Ltd, Mississauga, Canada; 14Department of Hematology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain 1 Catherine Diefenbach http://bit.ly/2JjV5Jn Disclosures CD holds stock in Gilead Sciences; has a consulting/advisory role for Seattle Genetics, Bayer, Bristol-Myers Squibb, Genentech/Roche, and Merck; has received research funding from Seattle Genetics, Genentech, Incyte, LAM Therapeutics, Merck, Bristol-Myers Squibb, Millennium, and MEI Pharma. BK has a consulting/advisory role for Roche, Genentech, Celgene, AbbVie, Pharmacyclics, and Acerta Pharma; has received research funding from Genentech, Acerta Pharma, and BeiGene; has provided expert testimony for Genentech. -
And Grand Overview
Welcome and Grand Overview Rose Aurigemma, PhD Acting Associate Director, Developmental Therapeutics Program Division of Cancer Treatment & Diagnosis, NCI July 23, 2021 Thank You to the Organizing Committee Weiwei Chen, Program Director, PTGB, DTP Rachelle Salomon, Program Director, BRB, DTP Sharad Verma, Program Director, PTGB, DTP Jason Yovandich, Chief, BRB, DTP Sundar Venkatachalam, Chief, PTGB, DTP 2 Introduction to the Developmental Therapeutics Program In 1955, congress created the Cancer Chemotherapy National Service Center which evolved, both structurally and functionally, into today’s Developmental Therapeutics Program (DTP). DTP’s involvement in the discovery or development of many anticancer therapeutics on the market today demonstrates its indelible impact on efforts to improve the health and well-being of people with cancer. 3 Approved Cancer Therapies with DTP Assistance 2018 Moxetumomab pasudotox-tdfk 1983 Etoposide (NSC 141540) 2015 Dinutuximab (Unituxin, NSC 764038) 1982 Streptozotocin (NSC 85998) Ecteinascidin 743 (NSC 648766) 1979 Daunorubicin (NSC 82151) 2012 Omacetaxine (homoharringtonine, NSC 141633) 1978 Cisplatin (cis-platinum) (NSC 119875) 2010 Eribulin (NSC 707389) 1977 Carmustine (BCNU) (NSC 409962) Sipuleucel-T (NSC 720270) 1976 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosurea (CCNU) 2009 Romidepsin (NSC 630176) (NSC 9037) Pralatrexate (NSC 713204) 1975 Dacarbazine (NSC 45388) 2004 Azacitidine (NSC 102816) 1974 Doxorubicin (NSC 123127) Cetuximab (NSC 632307) Mitomycin C (NSC 26980) 2003 Bortezomib (NSC 681239) 1973 -
A Phase Ib/II Study Evaluating the Safety and Efficacy Of
Official Title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Atezolizumab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Atezolizumab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma NCT Number: NCT02729896 Document Date: Protocol Version 8: 07-November-2018 PROTOCOL TITLE: A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF OBINUTUZUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS POLATUZUMAB VEDOTIN IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AND RITUXIMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS POLATUZUMAB VEDOTIN IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA PROTOCOL NUMBER: BO29561 VERSION NUMBER: 8 EUDRACT NUMBER: 2015-004845-25 IND NUMBER: 128036 TEST PRODUCT: Obinutuzumab (RO5072759) Rituximab (RO0452294) Atezolizumab (RO5541267) Polatuzumab vedotin (RO5541077) MEDICAL MONITOR: , Ph.D. SPONSOR: F. Hoffmann-La Roche Ltd DATE FINAL: Version 1: 12 November 2015 DATES AMENDED: Version 2: 14 January 2016 Version 3: 28 June 2016 Version 4: 17 November 2016 Version 5: 4 May 2017 Version 6: 21 December 2017 Version 7: 1 May 2018 Version 8: See electronic date stamp below. PROTOCOL AMENDMENT APPROVAL Approver's Name Title Date and Time (UTC) Company Signatory 07-Nov-2018 02:00:10 CONFIDENTIAL This clinical study is being sponsored globally by F. Hoffmann-La Roche Ltd of Basel, Switzerland. However, it may be implemented in individual countries by Roche’s local affiliates, including Genentech, Inc. in the United States. The information contained in this document, especially any unpublished data, is the property of F. -
Update in Pediatric Oncology Pediatric Leukemia
9/21/2016 Objectives • Review newest therapies in pediatric oncology • Discuss the use of Blinatumomab in pediatric Update in Pediatric Oncology patients • Review Car T‐Cell immunotherapy in pediatric Katie Bruce, PharmD, BCPPS patients Pharmacy Clinical Specialist • Discuss the latest therapy approved for use in Pediatric Oncology and BMT The Children’s Hospital at TriStar neuroblastoma Centennial Disclosure • I have no financial conflicts to disclose Pediatric Leukemia Pediatric Leukemia Classification • Acute lymphoblastic leukemia (ALL) is the most • Over 85% of childhood ALL is B‐cell ALL common cancer in children ▫ Most commonly precursor‐B cell ALL ▫ Accounts for ~30% of all cancers 2% mature B‐cell ALL ▫ 3000 new cases in US each year ▫ 15% T‐cell ALL (Birth –21 years old) Investigating use of nelarabine and/or high dose methotrexate ~ 80% are ALL and ~20% are AML ▫ Incidence of 3.4 cases per 100,000 • Risk Criteria ▫ Most common between 2 and 5 years old ▫ Initial WBC count ▫ Boys > girls ▫ Age • Higher incidence in Caucasians and Hispanics vs. African ▫ Cytogenetics American Children ▫ Immunologic subtype www.curesearch.org www.curesearch.org 1 9/21/2016 Risk Stratification Outcomes • ~85% overall 5‐year event‐free survival ▫ 90 –95 % in low‐ or standard‐risk pre‐B ALL with good response to induction chemotherapy ▫ 75 –85 % in high‐risk with good early response ▫ <75% in very high‐risk (Ph+, hypodiploid, CNS3) or slow response to chemo • T‐cell ALL survival lower at 70 –75 % • Infant ALL ▫ Poor prognosis with 10‐30% event‐free -
Qarziba, INN-Dinutuximab Beta
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Qarziba 4.5 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta. Each vial contains 20 mg dinutuximab beta in 4.5 mL. Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2). 4.2 Posology and method of administration Qarziba is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies. -
High Risk Therapy Made Easy: Supporting High Risk Patients Through Complex Therapy
8/21/2018 High Risk Therapy Made Easy: Supporting high risk patients through complex therapy Lori Ranney, MSN, APRN, CPNP, CPHON Mylynda Livingston, MSN, APRN, AC PC-PNP, CPON Teresa Herriage, DNP, APRN, CPNP, CPHON Children’s Minnesota Disclaimers and Confidentiality Protections Children’s Minnesota makes no representations or warranties about the accuracy, reliability, or completeness of the content. Content is provided “as is” and is for informational use only. It is not a substitute for professional medical advice, diagnosis, or treatment. Children’s disclaims all warranties, express or implied, statutory or otherwise, including without limitation the implied warranties of merchantability, non-infringement of third parties’ rights, and fitness for a particular purpose. This content was developed for use in Children’s patient care environment and may not be suitable for use in other patient care environments. Children’s does not endorse, certify, or assess third parties’ competency. You hold all responsibility for your use or nonuse of the content. Children’s shall not be liable for claims, losses, or damages arising from or related to any use or misuse of the content. This content and its related discussions are privileged and confidential under Minnesota’s peer review statute (Minn. Stat. § 145.61 et. seq.). Do not disclose unless appropriately authorized. Notwithstanding the foregoing, content may be subject to copyright or trademark law; use of such information requires Children’s permission. This content may include patient protected health information. You agree to comply with all applicable state and federal laws protecting patient privacy and security including the Minnesota Health Records Act and the Health Insurance Portability and Accountability Act and its implementing regulations as amended from time to time.