Part B Drugs Requiring Prior Authorization (Updated May 1, 2021)
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Ripretinib Demonstrated Activity Across All KIT/PDGFRA Mutations In
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study Patrick Schöffski1, Sebastian Bauer2, Michael Heinrich3, Suzanne George4, John Zalcberg5, Hans Gelderblom6, Cesar Serrano Garcia7, Robin L Jones8, Steven Attia9, Gina D’Amato10, Ping Chi11, Peter Reichardt12, Julie Meade13, Kelvin Shi13, Ying Su13, Rodrigo Ruiz-Soto13, Margaret von Mehren14, Jean-Yves Blay15 1University Hospitals Leuven, Leuven, Belgium; 2West German Cancer Center, Essen, Germany; 3OHSU Knight Cancer Institute, Portland, OR, USA; 4Dana-Farber Cancer Institute, Boston, MA, USA; 5Monash University, Melbourne, VIC, Australia; 6Leiden University Medical Center, Leiden, Netherlands; 7Vall d’Hebron Institute of Oncology, Barcelona, Spain; 8Royal Marsden and Institute of Cancer Research, London, UK; 9Mayo Clinic, Jacksonville, FL, USA; 10Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA; 11Memorial Sloan Kettering Cancer Center, New York, NY, USA; 12Sarcoma Center, Helios Klinikum Berlin-Buch, Berlin, Germany; 13Deciphera Pharmaceuticals, LLC, Waltham, MA, USA; 14Fox Chase Cancer Center, Philadelphia, PA, USA; 15Centre Leon Berard, Lyon, France KIT mutation analysis by combined tumor and liquid biopsy INTRODUCTION RESULTS Figure 7. Hazard ratio of PFS with different mutation groups by combined • Patients were grouped into 4 subsets: any KIT exon 9, any KIT exon 11, any KIT exon 13, and any KIT exon 17 tumor and liquid biopsy • 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
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. -
Clinical Policy: Sorafenib (Nexavar)
Clinical Policy: Sorafenib (Nexavar) Reference Number: CP.PHAR.69 Effective Date: 07.01.11 Last Review Date: 05.21 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Sorafenib (Nexavar®) is a kinase inhibitor. FDA Approved Indication(s) Nexavar (sorafenib) is indicated for the treatment of: Unresectable hepatocellular carcinoma (HCC); Advanced renal cell carcinoma (RCC); Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Nexavar is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Hepatocellular Carcinoma (must meet all): 1. Diagnosis of HCC; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Confirmation of Child-Pugh class A or B7 status; 5. Request meets one of the following (a or b):* a. Dose does not exceed 800 mg per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: Medicaid/HIM – 6 months Commercial – Length of Benefit B. Renal Cell Carcinoma (must meet all): 1. Diagnosis of advanced RCC; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Request meets one of the following (a or b):* Page 1 of 8 CLINICAL POLICY Sorafenib a. -
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. -
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 -
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. -
CDER Breakthrough Therapy Designation Approvals Data As of December 31, 2020 Total of 190 Approvals
CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2020 Total of 190 Approvals Submission Application Type and Proprietary Approval Use Number Number Name Established Name Applicant Date Treatment of patients with previously BLA 125486 ORIGINAL-1 GAZYVA OBINUTUZUMAB GENENTECH INC 01-Nov-2013 untreated chronic lymphocytic leukemia in combination with chlorambucil Treatment of patients with mantle cell NDA 205552 ORIGINAL-1 IMBRUVICA IBRUTINIB PHARMACYCLICS LLC 13-Nov-2013 lymphoma (MCL) Treatment of chronic hepatitis C NDA 204671 ORIGINAL-1 SOVALDI SOFOSBUVIR GILEAD SCIENCES INC 06-Dec-2013 infection Treatment of cystic fibrosis patients age VERTEX PHARMACEUTICALS NDA 203188 SUPPLEMENT-4 KALYDECO IVACAFTOR 21-Feb-2014 6 years and older who have mutations INC in the CFTR gene Treatment of previously untreated NOVARTIS patients with chronic lymphocytic BLA 125326 SUPPLEMENT-60 ARZERRA OFATUMUMAB PHARMACEUTICALS 17-Apr-2014 leukemia (CLL) for whom fludarabine- CORPORATION based therapy is considered inappropriate Treatment of patients with anaplastic NOVARTIS lymphoma kinase (ALK)-positive NDA 205755 ORIGINAL-1 ZYKADIA CERITINIB 29-Apr-2014 PHARMACEUTICALS CORP metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients NDA 206545 ORIGINAL-1 ZYDELIG IDELALISIB GILEAD SCIENCES INC 23-Jul-2014 for whom rituximab alone would be considered appropriate therapy due to other co-morbidities -
2020 Master Class Course Best Practices and Expanding Treatment Options in Soft Tissue Sarcomas Including GIST George D
2020 Master Class Course Best Practices and Expanding Treatment Options in Soft Tissue Sarcomas including GIST George D. Demetri, MD FACP FASCO 1 George D. Demetri, MD Faculty Disclosure • Scientific consultant with sponsored research to Dana-Farber: Bayer, Pfizer, Novartis, Epizyme, Roche/Genentech, Epizyme, LOXO Oncology, AbbVie, GlaxoSmithKline, Janssen, PharmaMar, Daiichi-Sankyo, AdaptImmune • Scientific consultant: GlaxoSmithKline, EMD-Serono, Sanofi, ICON plc, MEDSCAPE, Mirati, WCG/Arsenal Capital, Polaris, MJ Hennessey/OncLive, C4 Therapeutics, Synlogic, McCann Health • Consultant/SAB member with minor equity holding: G1 Therapeutics, Caris Life Sciences, Erasca Pharmaceuticals, RELAY Therapeutics, Bessor Pharmaceuticals, Champions Biotechnology, Caprion/HistoGeneX • Board of Directors member and Scientific Advisory Board Consultant with minor equity holding: Blueprint Medicines, Translate BIO • Patents/Royalties: Novartis royalty to Dana-Farber for use patent of imatinib in GIST • Non-Financial Interests: AACR Science Policy and Government Affairs Committee Chair, Alexandria Real Estate Equities, Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off label or investigational uses (any uses not approved by the FDA) of products or devices. 2 Soft Tissue Sarcomas: Approximate Anatomic Distribution Head and Neck 10% Upper extremities 15% Trunk 10% Retroperitoneal, pelvic and visceral Lower extremities 15% 50% (includes GIST and GYN sarcomas) Modified from Clark MA et al. NEJM 2005;353:701-11 3 Sarcomas represent an exceedingly diverse set of diseases Bone Sarcomas 10% GIST Un- differentiated Liposarcomas Leiomyo- Sarcomas 4 Ducimetiere et al. -
Rxoutlook® 1St Quarter 2019
® RxOutlook 1st Quarter 2020 optum.com/optumrx a RxOutlook 1st Quarter 2020 Orphan drugs continue to feature prominently in the drug development pipeline In 1983 the Orphan Drug Act was signed into law. Thirty seven years later, what was initially envisioned as a minor category of drugs has become a major part of the drug development pipeline. The Orphan Drug Act was passed by the United States Congress in 1983 in order to spur drug development for rare conditions with high unmet need. The legislation provided financial incentives to manufacturers if they could demonstrate that the target population for their drug consisted of fewer than 200,000 persons in the United States, or that there was no reasonable expectation that commercial sales would be sufficient to recoup the developmental costs associated with the drug. These “Orphan Drug” approvals have become increasingly common over the last two decades. In 2000, two of the 27 (7%) new drugs approved by the FDA had Orphan Designation, whereas in 2019, 20 of the 48 new drugs (42%) approved by the FDA had Orphan Designation. Since the passage of the Orphan Drug Act, 37 years ago, additional regulations and FDA designations have been implemented in an attempt to further expedite drug development for certain serious and life threatening conditions. Drugs with a Fast Track designation can use Phase 2 clinical trials to support FDA approval. Drugs with Breakthrough Therapy designation can use alternative clinical trial designs instead of the traditional randomized, double-blind, placebo-controlled trial. Additionally, drugs may be approved via the Accelerated Approval pathway using surrogate endpoints in clinical trials rather than clinical outcomes.