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Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami)
Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami) Media Release Copenhagen, Denmark and Lausanne, Switzerland, October 30, 2020 • ADC Therapeutics to continue the development and commercialization of Cami • Genmab to receive mid-to-high single-digit tiered royalty Genmab A/S (Nasdaq: GMAB) and ADC Therapeutics SA (NYSE: ADCT) today announced that they have executed an amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine (Cami). The parties first entered into a collaboration and license agreement in June 2013 for the development of Cami, an antibody drug conjugate (ADC) which combines Genmab’s HuMax®-TAC antibody targeting CD25 with ADC Therapeutics’ highly potent pyrrolobenzodiazepine (PBD) warhead technology. Under the terms of the 2013 agreement, the parties were to determine the path forward for continued development and commercialization of Cami upon completion of a Phase 1a/b clinical trial. ADC Therapeutics previously announced that Cami achieved an overall response rate of 86.5%, including a complete response rate of 48.6%, in Hodgkin lymphoma patients in this trial who had received a median of five prior lines of therapy. Cami is currently being evaluated in a 100-patient pivotal Phase 2 clinical trial intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The trial is more than 50 percent enrolled and ADC Therapeutics anticipates reporting interim results in the first half of 2021. “We have a long-standing relationship with the ADC Therapeutics team and believe they are an ideal partner for the ongoing development and potential commercialization of Cami,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. -
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. -
Draft Minutes PDCO 12-15 November 2019
11 December 2019 EMA/PDCO/615413/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division Paediatric Committee (PDCO) Minutes for the meeting on 12-15 November 2019 Chair: Koenraad Norga – Vice-Chair: Sabine Scherer Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). Of note, this set of minutes is a working document primarily designed for PDCO members and the work the Committee undertakes. Further information with relevant explanatory notes can be found at the end of this document. Note on access to documents Some documents mentioned in these minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). -
Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma
Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma Yuliya Linhares1, Mitul Gandhi2, Michael Chung3, Jennifer Adeleye4, David Ungar4, Mehdi Hamadani5 1Medical Oncology, Miami Cancer Institute, Baptist Health, Miami, FL, USA; 2Medical Oncology, Virginia Cancer Specialists, Gainesville, VA, USA; 3Hematology/Oncology, The Oncology Institute of Hope and Innovation, Downey, CA, USA; 4Clinical Development, ADC Therapeutics America, Inc., Murray Hill, NJ, USA; 5Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA Poster slides, 62nd ASH Annual Meeting and Poster session II, Sunday, December 6, 2020: Exposition, Virtual Meeting, December 5–8, 2020 7:00 am – 3:30 pm (Pacific Time) Introduction The prognosis of patients with DLBCL whose disease is refractory to initial chemotherapy (and are thus ineligible for ASCT) or relapse early after ASCT is extremely poor1,2 The development of a more effective, less toxic salvage treatment for DLBCL remains an unmet need2 Loncastuximab tesirine (Lonca) is an ADC comprising a Mechanism of action of Lonca humanized monoclonal anti-CD19 antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin, through a protease cleavable valine–alanine linker Rituximab is an anti-CD20 monoclonal antibody used as a standard component of care for the treatment of DLBCL, either as monotherapy or in combination with chemotherapy In a Phase 2 study, Lonca demonstrated single-agent antitumor activity with manageable toxicity in patients with R/R DLBCL3 Rituximab is licensed for treatment of NHL but is being used in combination with an unlicensed drug (loncastuximab tesirine) in this study 1. Crump M, et al. -
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. -
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. -
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. -
Antibody–Drug Conjugates: the Last Decade
pharmaceuticals Review Antibody–Drug Conjugates: The Last Decade Nicolas Joubert 1,* , Alain Beck 2 , Charles Dumontet 3,4 and Caroline Denevault-Sabourin 1 1 GICC EA7501, Equipe IMT, Université de Tours, UFR des Sciences Pharmaceutiques, 31 Avenue Monge, 37200 Tours, France; [email protected] 2 Institut de Recherche Pierre Fabre, Centre d’Immunologie Pierre Fabre, 5 Avenue Napoléon III, 74160 Saint Julien en Genevois, France; [email protected] 3 Cancer Research Center of Lyon (CRCL), INSERM, 1052/CNRS 5286/UCBL, 69000 Lyon, France; [email protected] 4 Hospices Civils de Lyon, 69000 Lyon, France * Correspondence: [email protected] Received: 17 August 2020; Accepted: 10 September 2020; Published: 14 September 2020 Abstract: An armed antibody (antibody–drug conjugate or ADC) is a vectorized chemotherapy, which results from the grafting of a cytotoxic agent onto a monoclonal antibody via a judiciously constructed spacer arm. ADCs have made considerable progress in 10 years. While in 2009 only gemtuzumab ozogamicin (Mylotarg®) was used clinically, in 2020, 9 Food and Drug Administration (FDA)-approved ADCs are available, and more than 80 others are in active clinical studies. This review will focus on FDA-approved and late-stage ADCs, their limitations including their toxicity and associated resistance mechanisms, as well as new emerging strategies to address these issues and attempt to widen their therapeutic window. Finally, we will discuss their combination with conventional chemotherapy or checkpoint inhibitors, and their design for applications beyond oncology, to make ADCs the magic bullet that Paul Ehrlich dreamed of. Keywords: antibody–drug conjugate; ADC; bioconjugation; linker; payload; cancer; resistance; combination therapies 1. -
5.01.582 Antibody-Drug Conjugates
MEDICAL POLICY – 5.01.582 Antibody-Drug Conjugates Effective Date: June 1, 2021 RELATED MEDICAL POLICIES: Last Revised: May 11, 2021 None Replaces: N/A Select a hyperlink below to be directed to that section. POLICY CRITERIA | 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 link to a molecule, known as an antigen, on the unhealthy cell. Monoclonal antibodies are produced in a laboratory. They are made to link to antigens usually found in high numbers on cancer cells. Antibody-drug conjugates combine monoclonal antibodies with certain chemotherapy drugs. The monoclonal antibodies find the cancer cells and the chemotherapy drug is released directly into those cells. The goal with this treatment is to target only cancer cells and spare nearby healthy cells. This policy describes when specific antibody-drug conjugates may be considered medically necessary. 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. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Drug Medical -
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). -
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 -
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,