DOCSLIB.ORG

Federal Register Notice 5-1-2020 Pdf Icon[PDF – 358

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

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. Occupational Safety and Health the depository institution may continue The information collected on the FR (NIOSH) of the Centers for Disease to report that account as a ‘‘savings 2886b is generally not considered Control and Prevention (CDC), in the deposit’’ or may instead choose to report confidential, but certain data may be Department of Health and Human that account as a ‘‘transaction account.’’ exempt from disclosure pursuant to Services announces that the following draft documents are available for public (3) Report title: Consolidated Report exemptions (b)(4) and (b)(7)(C) of FOIA, comment: (1) NIOSH Procedures for of Condition and Income for Edge and (5 U.S.C. 552(b)(4) and (b)(7)(C)). The Developing the NIOSH List of Agreement Corporations. information exempt from disclosure Agency form number: FR 2886b. Hazardous Drugs in Healthcare Settings OMB control number: 7100–0086. pursuant to (b)(4) consists of (Procedures); (2) NIOSH List of Applicable date: May 1, 2020. information provided on Schedule RC– Hazardous Drugs in Healthcare Settings, Frequency: Quarterly and annually. M (with the exception for item 3) and 2020 (List), including those drugs Respondents: Banking Edge and on Schedule RC–V, both of which proposed for placement on the 2020 agreement corporations and investment pertain to claims on and liabilities to List, and (3) Managing Hazardous Drug (nonbanking) Edge and agreement related organizations. The information Exposures: Information for Healthcare corporations. exempt from disclosure pursuant to Settings. Estimated number of respondents: exemption (b)(7)(C) is information DATES: Comments must be received by Banking Edge and agreement provided in the Patriot Act Contact June 30, 2020. corporations (quarterly): 9; banking Information section of the reporting ADDRESSES: Edge and agreement corporations form. Comments may be (annually): 1; investment Edge and submitted, identified by docket numbers agreement corporations (quarterly): 21; Current actions: The Board has CDC–2020–0046 and NIOSH–233–C, by investment Edge and agreement temporarily revised the instructions to either of the following two methods: corporations (annually): 7. the FR 2886b to update the definition of • Federal eRulemaking Portal: Estimated average hours per response: ‘‘savings deposits’’ in accordance with www.regulations.gov Follow the Banking Edge and agreement the amendments to Regulation D in the instructions for submitting comments. corporations (quarterly): 15.77 hours; interim final rule published on April 28, • Mail: NIOSH Docket Office, Robert banking Edge and agreement 2020 (85 FR 23445). Specifically, the A. Taft Laboratories, MS–C34, 1090 corporations (annually): 15.87; Board has temporarily revised the Tusculum Avenue, Cincinnati, OH investment Edge and agreement instructions on Schedule RC–E to 45226–1998. corporations (quarterly): 11.81; remove the transfer and withdrawal Instructions: All information received investment Edge and agreement limit from the definition of a savings in response to this notice must include corporations (annually): 10.82. deposit. Please note that this revision the agency name and the docket Estimated annual burden hours: does not require any changes to the form numbers (CDC–2020–0046; NIOSH– Banking Edge and agreement itself. As a result of the revision, if a 233–C). All relevant comments received corporations (quarterly): 568; banking depository institution chooses to will be posted without change to Edge and agreement corporations suspend enforcement of the six transfer www.regulations.gov, including any (annually): 16; investment Edge and limit on a ‘‘savings deposit,’’ the personal information provided. agreement corporations (quarterly): 992; depository institution may continue to FOR FURTHER INFORMATION CONTACT: investment Edge and agreement report that account as a ‘‘savings Barbara MacKenzie, NIOSH, Robert A. corporations (annually): 76. deposit’’ or may instead choose to report Taft Laboratories, 1090 Tusculum General description of report: The FR that account as a ‘‘transaction account.’’ Avenue, MS–C26, Cincinnati, OH 2886b reporting form is filed quarterly 45226, telephone (513) 533–8132 (not a and annually by banking Edge and Board of Governors of the Federal Reserve toll free number), email:bmackenzie@ agreement corporations and investment System, April 28, 2020. cdc.gov. (nonbanking) Edge and agreement Michele Taylor Fennell, SUPPLEMENTARY INFORMATION: corporations (collectively, Edges or Edge Assistant Secretary of the Board. corporations). The mandatory FR 2886b [FR Doc. 2020–09342 Filed 4–30–20; 8:45 am] I. Public Participation comprises an income statement with two schedules reconciling changes in BILLING CODE 6210–01–P A. Request for Comments capital and reserve accounts and a Interested parties are invited to balance sheet with 11 supporting participate in this activity by submitting VerDate Sep<11>2014 08:07 May 01, 2020 Jkt 250001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\01MYN1.SGM 01MYN1 25440 Federal Register / Vol. 85, No. 85 / Friday, May 1, 2020 / Notices written views, opinions, medical school professor, a neurologist, • Does the draft policy and recommendations, and/or data. and an anonymous commenter. NIOSH procedures clearly describe the process Comments are invited on any topic also conducted a peer review, with four used by NIOSH to screen and evaluate related to the procedures and drugs independent reviewers, of the draft drugs? identified in this notice, including three Policy and Procedures.2 • Are the screening and evaluation draft documents: (1) NIOSH Procedures Significant peer review and public categorization processes described by for Developing the NIOSH List of comments on the draft Policy and the draft policy and procedures Hazardous Drugs in Healthcare Settings Procedures are summarized and scientifically sound? (Procedures); (2) NIOSH List of answered below in Section II; public • Is the set of information sources Hazardous Drugs in Healthcare Settings, comments on specific drugs are used for classifying drugs sufficient to 2020 (List), including those drugs summarized and answered below in identify relevant hazards? Are there identified in this notice as being Section III. other information sources that should be proposed for placement on the List; and NIOSH carefully considered all of the included? (3) Managing Hazardous Drug peer reviews and public comments and • Is the threshold of information Exposures: Information for Healthcare determined that significant, substantial required to move from the screening Settings. All three draft documents are changes should be made to the draft process to the full evaluation process available in the docket for this activity. Policy and Procedures, the list of drugs clearly described? Is the information NIOSH also invites comments proposed for placement on the List, and threshold scientifically sound? specifically on the following questions also to the organization of the List itself. • Is the reconsideration process for related to this activity: The new drafts, entitled the Procedures addition or deletion of a drug to/from 1. Which unique ingredient identifier for Developing the NIOSH List of the hazardous drug list adequately is the most useful for users of the List? Hazardous Drugs in Healthcare Settings described? • 2. Because there is conflicting (Procedures) and the NIOSH List of Are there any issues not considered evidence about the hazard posed by Hazardous Drugs in Healthcare Settings, by the charge questions that should be botulinum toxins to the workers who 2020 (List) are found in the addressed? handle these drugs, NIOSH is not Supplemental Materials tab of the Overall, the independent peer proposing the placement of botulinum docket and are available for public reviewers found the draft Policy
Recommended publications
  • Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients

    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

    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 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

    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.
  • FLT3 Inhibitors in Acute Myeloid Leukemia Mei Wu1, Chuntuan Li2 and Xiongpeng Zhu2*

    FLT3 Inhibitors in Acute Myeloid Leukemia Mei Wu1, Chuntuan Li2 and Xiongpeng Zhu2*

    Wu et al. Journal of Hematology & Oncology (2018) 11:133 https://doi.org/10.1186/s13045-018-0675-4 REVIEW Open Access FLT3 inhibitors in acute myeloid leukemia Mei Wu1, Chuntuan Li2 and Xiongpeng Zhu2* Abstract FLT3 mutations are one of the most common findings in acute myeloid leukemia (AML). FLT3 inhibitors have been in active clinical development. Midostaurin as the first-in-class FLT3 inhibitor has been approved for treatment of patients with FLT3-mutated AML. In this review, we summarized the preclinical and clinical studies on new FLT3 inhibitors, including sorafenib, lestaurtinib, sunitinib, tandutinib, quizartinib, midostaurin, gilteritinib, crenolanib, cabozantinib, Sel24-B489, G-749, AMG 925, TTT-3002, and FF-10101. New generation FLT3 inhibitors and combination therapies may overcome resistance to first-generation agents. Keywords: FMS-like tyrosine kinase 3 inhibitors, Acute myeloid leukemia, Midostaurin, FLT3 Introduction RAS, MEK, and PI3K/AKT pathways [10], and ultim- Acute myeloid leukemia (AML) remains a highly resist- ately causes suppression of apoptosis and differentiation ant disease to conventional chemotherapy, with a me- of leukemic cells, including dysregulation of leukemic dian survival of only 4 months for relapsed and/or cell proliferation [11]. refractory disease [1]. Molecular profiling by PCR and Multiple FLT3 inhibitors are in clinical trials for treat- next-generation sequencing has revealed a variety of re- ing patients with FLT3/ITD-mutated AML. In this re- current gene mutations [2–4]. New agents are rapidly view, we summarized the preclinical and clinical studies emerging as targeted therapy for high-risk AML [5, 6]. on new FLT3 inhibitors, including sorafenib, lestaurtinib, In 1996, FMS-like tyrosine kinase 3/internal tandem du- sunitinib, tandutinib, quizartinib, midostaurin, gilteriti- plication (FLT3/ITD) was first recognized as a frequently nib, crenolanib, cabozantinib, Sel24-B489, G-749, AMG mutated gene in AML [7].
  • Antibody–Drug Conjugates

    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.
  • 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

    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

    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
  • Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML

    Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML

    POST-ASH Issue 4, 2016 Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML For more visit ResearchToPractice.com/5MJCASH2016 CME INFORMATION OVERVIEW OF ACTIVITY Each year, thousands of clinicians, basic scientists and other industry professionals sojourn to major international oncology conferences, like the American Society of Hematology (ASH) annual meeting, to hone their skills, network with colleagues and learn about recent advances altering state-of-the-art management in hematologic oncology. These events have become global stages where exciting science, cutting-edge concepts and practice-changing data emerge on a truly grand scale. This massive outpouring of information has enormous benefits for the hematologic oncology community, but the truth is it also creates a major challenge for practicing oncologists and hematologists. Although original data are consistently being presented and published, the flood of information unveiled during a major academic conference is unmatched and leaves in its wake an enormous volume of new knowledge that practicing oncologists must try to sift through, evaluate and consider applying. Unfortunately and quite commonly, time constraints and an inability to access these data sets leave many oncologists struggling to ensure that they’re aware of crucial practice-altering findings. This creates an almost insurmountable obstacle for clinicians in community practice because they are not only confronted almost overnight with thousands of new presentations and
  • Disruption of CSF-1R Signaling Inhibits Growth of AML with Inv(16)

    Disruption of CSF-1R Signaling Inhibits Growth of AML with Inv(16)

    Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2021 Disruption of CSF-1R signaling inhibits growth of AML with inv(16) Simonis, Alexander ; Russkamp, Norman F ; Mueller, Jan ; Wilk, C Matthias ; Wildschut, Mattheus H E ; Myburgh, Renier ; Wildner-Verhey van Wijk, Nicole ; Mueller, Rouven ; Balabanov, Stefan ; Valk, Peter J M ; Theocharides, Alexandre P A ; Manz, Markus G DOI: https://doi.org/10.1182/bloodadvances.2020003125 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-202789 Journal Article Published Version The following work is licensed under a Publisher License. Originally published at: Simonis, Alexander; Russkamp, Norman F; Mueller, Jan; Wilk, C Matthias; Wildschut, Mattheus H E; Myburgh, Renier; Wildner-Verhey van Wijk, Nicole; Mueller, Rouven; Balabanov, Stefan; Valk, Peter J M; Theocharides, Alexandre P A; Manz, Markus G (2021). Disruption of CSF-1R signaling inhibits growth of AML with inv(16). Blood advances, 5(5):1273-1277. DOI: https://doi.org/10.1182/bloodadvances.2020003125 STIMULUS REPORT Disruption of CSF-1R signaling inhibits growth of AML with inv(16) Alexander Simonis,1,* Norman F. Russkamp,1,* Jan Mueller,1 C. Matthias Wilk,1 Mattheus H. E. Wildschut,1,2 Renier Myburgh,1 Nicole Wildner-Verhey van Wijk,1 Rouven Mueller,1 Stefan Balabanov,1 Peter J. M. Valk,3 Alexandre P. A. Theocharides,1 and Markus G. Manz1 1Department of Medical Oncology and Hematology, University Hospital
  • Update in Pediatric Oncology Pediatric Leukemia

    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
  • ADCC-Inducing Antibody Trastuzumab and Selection of KIR-HLA Ligand Mismatched Donors Enhance the NK Cell Anti-Breast Cancer Response

    ADCC-Inducing Antibody Trastuzumab and Selection of KIR-HLA Ligand Mismatched Donors Enhance the NK Cell Anti-Breast Cancer Response

    cancers Article ADCC-Inducing Antibody Trastuzumab and Selection of KIR-HLA Ligand Mismatched Donors Enhance the NK Cell Anti-Breast Cancer Response Femke A. I. Ehlers 1,2,3 , Nicky A. Beelen 1,2,3, Michel van Gelder 2,3, Tom M. J. Evers 1,3,4, Marjolein L. Smidt 3,5, Loes F. S. Kooreman 3,6 , Gerard M. J. Bos 2,3 and Lotte Wieten 1,3,* 1 Department of Transplantation Immunology, Tissue Typing Laboratory, Maastricht University Medical Center+, 6229 HX Maastricht, The Netherlands; [email protected] (F.A.I.E.); [email protected] (N.A.B.); [email protected] (T.M.J.E.) 2 Department of Internal Medicine, Division of Hematology, Maastricht University Medical Center+, 6229 HX Maastricht, The Netherlands; [email protected] (M.v.G.); [email protected] (G.M.J.B.) 3 GROW—School for Oncology and Developmental Biology, Maastricht University, 6229 GT Maastricht, The Netherlands; [email protected] (M.L.S.); [email protected] (L.F.S.K.) 4 Medical Systems Biophysics and Bioengineering, Leiden Academic Centre for Drug Research, Faculty of Science, Leiden University, 2333 CC Leiden, The Netherlands 5 Department of Surgery, Maastricht University Medical Center+, 6229 HX Maastricht, The Netherlands 6 Department of Pathology, Maastricht University Medical Center+, 6229 HX Maastricht, The Netherlands * Correspondence: [email protected] Citation: Ehlers, F.A.I.; Beelen, N.A.; Simple Summary: Natural killer (NK) cells are potent killers of tumor cells. Many tumors, includ- van Gelder, M.; Evers, T.M.J.; Smidt, ing breast cancers, develop mechanisms to suppress anti-tumor immune responses, requiring the M.L.; Kooreman, L.F.S.; Bos, G.M.J.; development of strategies to overcome suppression.