Systemic Therapy Update
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Oncology Agents
APPROVED DRAFT PA Criteria Initial Approval Date: July 11, 2018 Revised Dates: January 20, 2021, October 14, 2020, October 10, 2018 CRITERIA FOR PRIOR AUTHORIZATION OncologyChemotherapy Agents BILLING CODE TYPE For drug coverage and provider type information, see the KMAP Reference Codes webpage. MANUAL GUIDELINES Prior authorization will be required for all current and future dose forms available. All medication-specific criteria will be reviewed according to the criteria below. Brand Name Generic Name Brand Name Generic Name Adcetris (brentuximab vedotin) Ibrance (palbociclib) Afinitor (everolimus) Iclusig (ponatinib hcl) Alecensa (alectinib hcl) Idhifa (enasidenib) Alunbrig (brigatinib) Imbruvica (ibrutinib) Arranon (nelarabine) Imfinzi (durvalumab) Avastin (bevacizumab) Inlyta (axitinib) Ayvakit (avapritinib) Ixempra (ixabepilone) Balversa (erdafitinib) Jakafi (ruxolitinib phosphate) Bavencio (avelumab) Jevtana (cabazitaxel) Belrapzo (bendamustine) Kadcyla (ado-trastuzumab) Bicnu (carmustine) Kanjinti (trastuzumab) Blincyto (blinatumomab) Keytruda (pembrolizumab) Bosulif (bosutinib) Kisqali (ribociclib) Braftovi (encorafenib) Kisqali Femara (ribociclib-letrozole) Brukinsa (zanubrutinib) Kyprolis (carfilzomib) Cabometyx (cabozantinib) Lartruvo (olaratumab) Calquence (acalabrutinib) Lenvima (lenvatinib) Cotellic (cobimetinib) Lonsurf (trifluridine-tipiracil) Cyramza (ramucirumab) Lorbrena (lorlatinib) Darzalex (daratumumab) Lynparza (olaparib) Darzalex Faspro (daratumumab and Matulane (procarbazine) hyaluronidase) Mekinist (trametinib) -
Clinical Response of the Novel Activating ALK-I1171T
http://www.diva-portal.org This is the published version of a paper published in Cold Spring Harbor Molecular Case Studies. Citation for the original published paper (version of record): Guan, J., Fransson, S., Siaw, J T., Treis, D., Van den Eynden, J. et al. (2018) Clinical response of the novel activating ALK-I1171T mutation in neuroblastoma o the ALK inhibitor ceritinib Cold Spring Harbor Molecular Case Studies, 4(4): a002550 https://doi.org/10.1101/mcs.a002550 Access to the published version may require subscription. N.B. When citing this work, cite the original published paper. Permanent link to this version: http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-154087 Downloaded from molecularcasestudies.cshlp.org on December 12, 2018 - Published by Cold Spring Harbor Laboratory Press COLD SPRING HARBOR Molecular Case Studies | RESEARCH ARTICLE Clinical response of the novel activating ALK-I1171T mutation in neuroblastoma to the ALK inhibitor ceritinib Jikui Guan,1,2,12 Susanne Fransson,3,12 Joachim Tetteh Siaw,1,12 Diana Treis,4,12 Jimmy Van den Eynden,1 Damini Chand,1 Ganesh Umapathy,1 Kristina Ruuth,5 Petter Svenberg,4 Sandra Wessman,6,7 Alia Shamikh,6,7 Hans Jacobsson,8 Lena Gordon,9 Jakob Stenman,10 Pär-Johan Svensson,10 Magnus Hansson,11 Erik Larsson,1 Tommy Martinsson,3 Ruth H. Palmer,1 Per Kogner,6,7 and Bengt Hallberg1 1Department of Medical Biochemistry and Cell Biology, Institute of Biomedicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg 40530, Sweden; 2Children’s Hospital Affiliated to Zhengzhou University, -
ZYKADIA (Ceritinib) RATIONALE for INCLUSION in PA PROGRAM
ZYKADIA (ceritinib) RATIONALE FOR INCLUSION IN PA PROGRAM Background Zykadia is used in patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC), which is caused by a defect in a gene called anaplastic lymphoma kinase (ALK). Zykadia is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC (1). Regulatory Status FDA- approved indication: Zykadia is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (1). Off-Label Uses: (2-3) 1. Inflammatory Myofibroblastic Tumor (IMT) with ALK translocation Zykadia can cause hepatotoxicity therefore liver function tests including AST, ALT and total bilirubin should be monitored at least monthly. Zykadia can cause interstitial lung disease (ILD) or pneumonitis. Zykadia should be permanently discontinued in patients diagnosed with treatment- related ILD/pneumonitis. Zykadia can cause QTc interval prolongation, which requires monitoring of electrocardiograms and electrolytes in patients with congestive heart failure (1). Zykadia is pregnancy category D and may cause fetal harm when administered to a pregnant woman (1). Safety and effectiveness of Zykadia in pediatric patients have not been established (1). Summary Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC. Safety and effectiveness of Zykadia in patients under 18 years of age have not been established (1). Zykadia FEP Clinical Rationale ZYKADIA (ceritinib) Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Zykadia while maintaining optimal therapeutic outcomes. -
Phase I/II Study Evaluating the Safety and Clinical Efficacy of Temsirolimus and Bevacizumab in Patients with Chemotherapy Refra
Investigational New Drugs (2019) 37:331–337 https://doi.org/10.1007/s10637-018-0687-5 PHASE II STUDIES Phase I/II study evaluating the safety and clinical efficacy of temsirolimus and bevacizumab in patients with chemotherapy refractory metastatic castration-resistant prostate cancer Pedro C. Barata1 & Matthew Cooney2 & Prateek Mendiratta 2 & Ruby Gupta3 & Robert Dreicer4 & Jorge A. Garcia3 Received: 25 September 2018 /Accepted: 16 October 2018 /Published online: 7 November 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 Summary Background Mammalian target of rapamycin (mTOR) pathway and angiogenesis through vascular endothelial growth factor (VEGF) have been shown to play important roles in prostate cancer progression. Preclinical data in prostate cancer has suggested the potential additive effect dual inhibition of VEGF and mTOR pathways. In this phase I/II trial we assessed the safety and efficacy of bevacizumab in combination with temsirolimus for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC). Methods In the phase I portion, eligible patients received temsirolimus (20 mg or 25 mg IV weekly) in combination with a fixed dose of IV bevacizumab (10 mg/kg every 2 weeks). The primary endpoint for the phase II portion was objective response measured by either PSA or RECIST criteria. Exploratory endpoints included changes in circulating tumor cells (CTC) and their correlation with PSA response to treatment. Results Twenty-one patients, median age 64 (53–82), with pre- treatment PSA of 205.3 (11.1–1801.0), previously treated with a median of 2 (0–5) lines of therapy for mCRPC received the combination of temsirolimus weekly at 20 mg (n =4)or25mg(n = 17) with bevacizumab 10 mg/kg every 2 weeks (n =21). -
Pediatric Patients with Refractory Central Nervous System Tumors: Experiences of a Clinical Trial Combining Bevacizumab and Temsirolimus
ANTICANCER RESEARCH 34: 1939-1946 (2014) Pediatric Patients with Refractory Central Nervous System Tumors: Experiences of a Clinical Trial Combining Bevacizumab and Temsirolimus SARINA A. PIHA-PAUL1*, SANG JOON SHIN1*, TRIBHAWAN VATS2, NANDITA GUHA-THAKURTA3, JOANN AARON1, MICHAEL RYTTING2, EUGENIE KLEINERMAN2 and RAZELLE KURZROCK4 Departments of 1Investigational Cancer Therapeutics (Phase I Clinical Trials Program), 2Pediatric Oncology, and 3Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, U.S.A.; 4Moores Cancer Center, The University of California San Diego, La Jolla, CA, U.S.A. Abstract. Background: Pre-clinical findings suggest that Primary central nervous system (CNS) malignancies are the combination treatment with bevacizumab and temsirolimus second most frequent tumors in pediatric patients, with 3.4 could be effective against malignant pediatric central cases per 100,000 person-years of the estimated incidence for nervous system (CNS) tumors. Patients and Methods: Six children and adolescents at or below 19 years of age in the pediatric patients were treated as part of a phase I trial with United States (1, 2). Advances in diagnostic and therapeutic intravenous temsirolimus 25 mg on days 1, 8, 15, and modalities have improved the 5-year survival rates of children bevacizumab at 5, 10, or 15 mg/kg on day 1 of each 21-day with primary CNS tumors (3). However, due to the cycle until disease progression or patient withdrawal. emergence of drug-resistant clones, the outcome is poor in Results: The median patient age was six years (range=3-14 progressive disease. During the past decade, targeted years). The primary diagnoses were glioblastoma multiforme therapies have been increasingly identified for the most (n=2), medullobalstoma (n=2), pontine glioma (n=1) and common adult malignancies. -
WHO Drug Information Vol 22, No
WHO Drug Information Vol 22, No. 1, 2008 World Health Organization WHO Drug Information Contents Challenges in Biotherapeutics Miglustat: withdrawal by manufacturer 21 Regulatory pathways for biosimilar Voluntary withdrawal of clobutinol cough products 3 syrup 22 Pharmacovigilance Focus Current Topics WHO Programme for International Drug Proposed harmonized requirements: Monitoring: annual meeting 6 licensing vaccines in the Americas 23 Sixteen types of counterfeit artesunate Safety and Efficacy Issues circulating in South-east Asia 24 Eastern Mediterranean Ministers tackle Recall of heparin products extended 10 high medicines prices 24 Contaminated heparin products recalled 10 DacartTM development terminated and LapdapTM recalled 11 ATC/DDD Classification Varenicline and suicide attempts 11 ATC/DDD Classification (temporary) 26 Norelgestromin-ethynil estradiol: infarction ATC/DDD Classification (final) 28 and thromboembolism 12 Emerging cardiovascular concerns with Consultation Document rosiglitazone 12 Disclosure of transdermal patches 13 International Pharmacopoeia Statement on safety of HPV vaccine 13 Cycloserine 30 IVIG: myocardial infarction, stroke and Cycloserine capsules 33 thrombosis 14 Erythropoietins: lower haemoglobin levels 15 Recent Publications, Erythropoietin-stimulating agents 15 Pregabalin: hypersensitivity reactions 16 Information and Events Cefepime: increased mortality? 16 Assessing the quality of herbal medicines: Mycophenolic acid: pregnancy loss and contaminants and residues 36 congenital malformation 17 Launch -
Haematological Malignancies
Parikh_EU Haematology 03/03/2010 12:51 Page 43 Haematological Malignancies Clinical Management of Relapsed/Refractory Acute Myeloid Leukaemia Sameer A Parikh1 and Stefan Faderl2 1. Fellow; 2. Associate Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center DOI: 10.17925/EOH.2010.04.0.43 Abstract Conventional chemotherapy for patients with relapsed/refractory acute myeloid leukaemia (AML) remains unsatisfactory, with median survival ranging from 18 weeks following first relapse to six weeks in those with a second or higher relapse. The only potentially curative therapy is stem cell transplantation. Duration of first complete remission (CR) is the best predictor of response to salvage therapy. Novel therapies directed against a number of molecular aberrations associated with AML are being developed, including anti-CD33 monoclonal antibodies, FMS-like tyrosine kinase (FLT3) inhibitors, nucleoside analogues, hypomethylating agents and histone deacetylatase inhibitors, among others. Clinical trials combining novel agents with conventional chemotherapy are of particular interest, and definition of dose, schedule and combination partners remains an area of intense research. Keywords Acute myeloid leukaemia (AML), salvage therapy, chemotherapy, targeted therapy, nucleoside analogues, FLT3 inhibition, epigenetic therapy Disclosure: Sameer A Parikh has no conflicts of interst to declare. Stefan Faderl receives research funding from Genzyme Oncology and has been a member of advisory board meetings conducted by Genzyme Oncology. He is also a member of the speaker’s bureau of Eisai Inc. Received: 22 September 2009 Accepted: 23 February 2010 Citation: European Haematology, 2010;4:43–6 Correspondence: Stefan Faderl, Department of Leukemia, Unit 428, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, US. -
Fam-Trastuzumab Deruxtecan-Nxki Submitted by Daiichi
Dan Liang, PharmD Associate Director, Medical Information & Education Daiichi Sankyo, Inc. 211 Mount Airy Road Basking Ridge, NJ 07920 Phone: 908-992-7054 Email: [email protected] Date of request: July 9, 2020 NCCN Panel: Colon Cancer and Rectal Cancer On behalf of Daiichi Sankyo, Inc. and AstraZeneca Pharmaceuticals LP, I respectfully request the NCCN Guideline Panel for Colon and Rectal Cancers to review data from the clinical study1 in support of fam-trastuzumab deruxtecan-nxki, also known as T-DXd, as a monotherapy option for the treatment of patients with HER2-positive unresectable and/or metastatic colorectal cancer. Specific Changes: We respectfully ask the NCCN panel to consider the following: • COL-D1 through COL-D6 and REC-F1 through REC-F6, “Continuum of Care - Systemic Therapy for Advanced or Metastatic Disease” o Add “Fam-trastuzumab deruxtecan-nxki (HER2-positive and RAS and BRAF WT)” to the following: . COL-D1 and REC-F1: “Patient not appropriate for intensive therapy” . COL-D2 and REC-F2: “Previous oxaliplatin-based therapy without irinotecan” . COL-D3 and REC-F3: “Previous irinotecan-based therapy without oxaliplatin” . COL-D4 and REC-F4: “Previous treatment with oxaliplatin and irinotecan” . COL-D5 and REC-F5: “Previous therapy without irinotecan or oxaliplatin” . COL-D6 and REC-F6: “FOLFOX or CAPEOX or (FOLFOX or CAPEOX) + bevacizumab” • COL-D11 and REC-F11, “Systemic Therapy for Advanced or Metastatic Disease – Chemotherapy Regimens” o Add “Fam-trastuzumab deruxtecan-nxki 6.4 mg/kg IV on Day 1, cycled every 21 days” with a footnote: “fam-trastuzumab deruxtecan-nxki is approved for metastatic HER2-positive breast cancer at a different dose of 5.4 mg/kg IV on Day 1, cycled every 21 days” FDA Clearance: ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. -
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. -
Pharmaceuticals and Medical Devices Safety Information No
Pharmaceuticals and Medical Devices Safety Information No. 277 February 2011 Table of Contents 1. Safety Measures for Gemtuzumab Ozogamicin (Genetical Recombination) .......................................................................... 5 2. Important Safety Information .................................................................... 12 (1) Imatinib Mesilate, Nilotinib Hydrochloride Hydrate ....................................... 12 (2) Sunitinib Malate ............................................................................................ 15 (3) Pilsicainide Hydrochloride Hydrate ............................................................... 17 3. Revision of Precautions (No. 223) .......................................................... 21 Ciclosporin (oral and injectable dosage forms) (and 13 others) ........................ 21 4. List of Products Subject to Early Post-marketing Phase Vigilance .................................................. 26 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare (MHLW). It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. The PMDSI is available on the Pharmaceuticals and Medical Devices Agency (PMDA) website (http://www.pmda.go.jp/english/index.html) and on the MHLW website (http://www.mhlw.go.jp/, only available in Japanese language). Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical -
Advances in Epidermal Growth Factor Receptor Specific Immunotherapy: Lessons to Be Learned from Armed Antibodies
www.oncotarget.com Oncotarget, 2020, Vol. 11, (No. 38), pp: 3531-3557 Review Advances in epidermal growth factor receptor specific immunotherapy: lessons to be learned from armed antibodies Fleury Augustin Nsole Biteghe1,*, Neelakshi Mungra2,*, Nyangone Ekome Toung Chalomie4, Jean De La Croix Ndong5, Jean Engohang-Ndong6, Guillaume Vignaux7, Eden Padayachee8, Krupa Naran2,* and Stefan Barth2,3,* 1Department of Radiation Oncology and Biomedical Sciences, Cedars-Sinai Medical, Los Angeles, CA, USA 2Medical Biotechnology & Immunotherapy Research Unit, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa 3South African Research Chair in Cancer Biotechnology, Department of Integrative Biomedical Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa 4Sun Yat-Sen University, Zhongshan Medical School, Guangzhou, China 5Department of Orthopedic Surgery, New York University School of Medicine, New York, NY, USA 6Department of Biological Sciences, Kent State University at Tuscarawas, New Philadelphia, OH, USA 7Arctic Slope Regional Corporation Federal, Beltsville, MD, USA 8Department of Physiology, University of Kentucky, Lexington, KY, USA *These authors contributed equally to this work Correspondence to: Stefan Barth, email: [email protected] Keywords: epidermal growth factor receptor (EGFR); recombinant immunotoxins (ITs); targeted human cytolytic fusion proteins (hCFPs); recombinant antibody-drug conjugates (rADCs); recombinant antibody photoimmunoconjugates (rAPCs) Received: May 30, 2020 Accepted: August 11, 2020 Published: September 22, 2020 Copyright: © 2020 Biteghe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. -
Whither Radioimmunotherapy: to Be Or Not to Be? Damian J
Published OnlineFirst April 20, 2017; DOI: 10.1158/0008-5472.CAN-16-2523 Cancer Perspective Research Whither Radioimmunotherapy: To Be or Not To Be? Damian J. Green1,2 and Oliver W. Press1,2,3 Abstract Therapy of cancer with radiolabeled monoclonal antibodies employing multistep "pretargeting" methods, particularly those has produced impressive results in preclinical experiments and in utilizing bispecific antibodies, have greatly enhanced the thera- clinical trials conducted in radiosensitive malignancies, particu- peutic efficacy of radioimmunotherapy and diminished its toxi- larly B-cell lymphomas. Two "first-generation," directly radiola- cities. The dramatically improved therapeutic index of bispecific beled anti-CD20 antibodies, 131iodine-tositumomab and 90yttri- antibody pretargeting appears to be sufficiently compelling to um-ibritumomab tiuxetan, were FDA-approved more than a justify human clinical trials and reinvigorate enthusiasm for decade ago but have been little utilized because of a variety of radioimmunotherapy in the treatment of malignancies, particu- medical, financial, and logistic obstacles. Newer technologies larly lymphomas. Cancer Res; 77(9); 1–6. Ó2017 AACR. "To be, or not to be, that is the question: Whether 'tis nobler in the pembrolizumab (anti-PD-1), which are not directly cytotoxic mind to suffer the slings and arrows of outrageous fortune, or to take for cancer cells but "release the brakes" on the immune system, arms against a sea of troubles, And by opposing end them." Hamlet. allowing cytotoxic T cells to be more effective at recognizing –William Shakespeare. and killing cancer cells. Outstanding results have already been demonstrated with checkpoint inhibiting antibodies even in far Introduction advanced refractory solid tumors including melanoma, lung cancer, Hodgkin lymphoma and are under study for a multi- Impact of monoclonal antibodies on the field of clinical tude of other malignancies (4–6).