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Danial E Baker, Kyle T Ingram
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
November 2015: Hospital Pharmacy
Amanda Long, Emmanuel Chigutsa, Johan Wallin
Necitumumab is a second-generation, recombinant, human immunoglobulin G1, epidermal growth factor (EGFR) receptor antibody that specifically blocks the ligand binding site of EGFR. Necitumumab potentially acts by blocking ligand epidermal growth factor (EGF) binding-mediated activation of the EGFR signaling pathway, inhibiting tumor growth, angiogenesis, and anti-apoptotic mechanisms. Necitumumab inhibited the interaction of EGF and EGFR with a concentration that inhibits binding by 50 % of approximately 0...
September 30, 2016: Clinical Pharmacokinetics
Nwamaka Umeweni, Helen Knight, Gary McVeigh
No abstract text is available yet for this article.
November 2016: Lancet Oncology
Loretta Fala
No abstract text is available yet for this article.
March 2016: American Health & Drug Benefits
Yosuke Tamura, Hiroshi Nokihara, Kazunori Honda, Yuko Tanabe, Hajime Asahina, Yasuhide Yamada, Sotaro Enatsu, Raffael Kurek, Noboru Yamamoto, Tomohide Tamura
PURPOSE: To establish the safety and pharmacokinetic profile of necitumumab in Japanese patients with advanced solid tumors not responsive to standard therapy or for which no standard therapy was available. METHODS: In this phase I study, patients aged ≥20 years with advanced solid tumors, and an Eastern Cooperative Oncology Group performance statuses of 0-1 were enrolled in a 3 + 3 design, with dose-escalation based on dose-limiting toxicity (DLT). Planned dose levels were: cohort 1: 600 mg IV, days 1 and 8, every 3 weeks; cohort 2: 800 mg IV, day 1, every 2 weeks; and cohort 3: 800 mg IV, days 1 and 8, every 3 weeks...
September 15, 2016: Cancer Chemotherapy and Pharmacology
Carlo Genova, Fred R Hirsch
Despite significant progress, new therapeutic approaches for advanced non-small cell lung cancer (NSCLC) are highly needed, particularly for the treatment of patients with squamous cell carcinoma. The epidermal growth factor receptor (EGFR) is often overexpressed in NSCLC and represents a relevant target for specific treatments. Although EGFR mutations are more frequent in non-squamous histology, the receptor itself is more often overexpressed in squamous NSCLC. Necitumumab is a human monoclonal antibody that is able to inhibit the EGFR pathway and cause antibody-dependent cell cytotoxicity...
2016: OncoTargets and Therapy
Martin Reck, Michael Thomas, Cornelia Kropf-Sanchen, Jörg Mezger, Mark A Socinski, Henrik Depenbrock, Victoria Soldatenkova, Jacqueline Brown, Thomas Krause, Nick Thatcher
BACKGROUND: In the SQUIRE study, adding the anti-epidermal growth factor receptor (EGFR) IgG1 antibody necitumumab to first-line gemcitabine and cisplatin (GC + N) in advanced squamous non-small-cell lung cancer (sqNSCLC) significantly improved overall survival (OS); the safety profile was acceptable. We explored data for the German subpopulation (N = 96) of SQUIRE patients with EGFR-expressing tumors. PATIENT AND METHODS: Patients with stage IV sqNSCLC were randomized 1:1 to up to 6 cycles of open-label GC + N or GC alone...
2016: Oncology Research and Treatment
Corey J Langer, Coleman Obasaju, Paul Bunn, Philip Bonomi, David Gandara, Fred R Hirsch, Edward S Kim, Ronald B Natale, Silvia Novello, Luis Paz-Ares, Maurice Pérol, Martin Reck, Suresh S Ramalingam, Craig H Reynolds, Mark A Socinski, David R Spigel, Heather Wakelee, Carlos Mayo, Nick Thatcher
Squamous cell lung cancer (sqCLC) is an aggressive form of cancer that poses many therapeutic challenges. Patients tend to be older, present at a later stage, and have a high incidence of comorbidities, which can compromise treatment delivery and exacerbate toxicity. In addition, certain agents routinely available for nonsquamous cell histologic subtypes, such as bevacizumab and pemetrexed, are contraindicated or lack efficacy in sqCLC. Therapeutic progress has been much slower for advanced sqCLC, with median survival times of approximately 9 to 11 months in most studies...
December 2016: Journal of Thoracic Oncology
Thomas E Stinchcombe
Targeted therapies have become standard therapies for patients with non-small cell lung cancer (NSCLC). A phase III trial of carboplatin and paclitaxel with and without bevacizumab in patients with advanced NSCLC with non-squamous histology demonstrated a statistically significant improvement in efficacy. In patients with NSCLC with an activating epidermal growth factor receptor (EGFR) mutation (defined as exon 19 deletion and exon 21 L858R point mutation), phase III trials of EGFR tyrosine kinase inhibitors (TKI) compared to platinum-based chemotherapy have demonstrated superior efficacy in the first-line setting...
2016: Cancer Treatment and Research
Pilar Garrido, Jose Palacios
No abstract text is available yet for this article.
August 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
David C Smith, John Powderly, James J Lee, Dale R Shepard, Johan Wallin, Archana Chaudhary, Grace Yi Chao, Wee Teck Ng, Malcolm I Mitchell, Gerrit Grau, Raffael Kurek, Patricia LoRusso
PURPOSE: Necitumumab is a second-generation, recombinant, human immunoglobulin G1 monoclonal antibody that blocks the ligand binding site of the epidermal growth factor receptor. The primary objective of this phase 2 study, conducted in accordance with International Conference on Harmonisation E14 guidance, was to determine the effect of necitumumab treatment on QT/QTc interval in patients with advanced solid tumors. METHODS: Patients received necitumumab monotherapy at an absolute dose of 800 mg, once per week for each 6-week cycle...
August 2016: Cancer Chemotherapy and Pharmacology
Fern E Lawson, J Aubrey Waddell, Dominic A Solimando
The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. This column reviews various issues related to preparation, dispensing, and administration of antineoplastic therapy, and the agents, both commercially available and investigational, used to treat malignant diseases. Questions or suggestions for topics should be addressed to Dominic A. Solimando, Jr, President, Oncology Pharmacy Services, Inc., 4201 Wilson Blvd #110-545, Arlington, VA 22203, e-mail: OncRxSvc@comcast...
May 2016: Hospital Pharmacy
L Paz-Ares, M A Socinski, J Shahidi, R R Hozak, V Soldatenkova, R Kurek, M Varella-Garcia, N Thatcher, F R Hirsch
BACKGROUND: SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression. PATIENTS AND METHODS: Patients with pathologically confirmed stage IV sq-NSCLC were randomized 1:1 to receive a maximum of six 3-week cycles of gemcitabine (1250 mg/m(2) i...
August 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Martin Reck, Mark A Socinski, Alexander Luft, Aleksandra Szczęsna, Mircea Dediu, Rodryg Ramlau, György Losonczy, Olivier Molinier, Christian Schumann, Richard J Gralla, Philip Bonomi, Jacqueline Brown, Victoria Soldatenkova, Nadia Chouaki, Coleman Obasaju, Patrick Peterson, Nick Thatcher
INTRODUCTION: Necitumumab, a second-generation, recombinant human immunoglobulin G1 epidermal growth factor receptor antibody in the phase 3 SQUIRE trial (NCT00981058), increased survival benefit for patients randomized to receive necitumumab plus gemcitabine-cisplatin compared with those who received gemcitabine-cisplatin. Here we characterize health-related quality of life (HRQoL) and tolerability results. METHODS: A total of 1093 patients with stage IV squamous non-small cell lung cancer were randomized 1:1 to receive necitumumab (800 mg absolute dose intravenously [IV]) plus gemcitabine-cisplatin (gemcitabine = 1250 mg/m(2) IV on days 1 and 8; cisplatin = 75 mg/m(2) IV on day 1) or gemcitabine-cisplatin alone (every 21 days) for up to six cycles...
June 2016: Journal of Thoracic Oncology
Jon Zugazagoitia, Santiago Ponce, Luis Paz-Ares
No abstract text is available yet for this article.
February 2016: Translational Lung Cancer Research
Tania Losanno, Antonio Rossi, Paolo Maione, Alba Napolitano, Cesare Gridelli
INTRODUCTION: In recent years, several clinical trials have evaluated the efficacy and safety of biological therapies in lung cancer. Epidermal growth factor receptor (EGFR) and the axis vascular endothelial growth factor receptor (VEGF/VEGFR) are targeted by small molecules and monoclonal antibodies (mAbs), especially in non-squamous non-small-cell lung cancer (NSCLC). AREAS COVERED: The current state of the art of anti-EGFR and antiangiogenic monoclonal antibodies in metastatic NSCLC is reviewed and discussed...
June 2016: Expert Opinion on Biological Therapy
E Elez, A Hendlisz, T Delaunoit, J Sastre, A Cervantes, R Varea, G Chao, J Wallin, J Tabernero
BACKGROUND: This single-arm phase II study investigated the EGFR monoclonal antibody necitumumab plus modified FOLFOX6 (mFOLFOX6) in first-line treatment of locally advanced or metastatic colorectal cancer (mCRC). METHODS: Patients received 800-mg intravenous necitumumab (day 1; 2-week cycles), followed by oxaliplatin 85 mg m(-2), folinic acid 400 mg m(-2), and 5-fluorouracil (400 mg m(-2) bolus then 2400 mg m(-2) over 46 h). Radiographic evaluation was performed every 8 weeks until progression...
February 16, 2016: British Journal of Cancer
Karly P Garnock-Jones
Eli Lilly is developing necitumumab (Portrazza™), an intravenously administered fully human IgG monoclonal antibody directed against the epidermal growth factor receptor (EGFR), which is expressed in a variety of solid tumours and has been implicated in promoting oncogenesis and tumour progression. Necitumumab is approved as a part of combination therapy (with gemcitabine and cisplatin) in the USA for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), and regulatory submissions have been made in the EU for this same indication...
February 2016: Drugs
Janice M Reichert
The number of novel antibody therapeutics that received first marketing approvals in 2015 met expectations, with 6 (alirocumab (Praluent®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) granted first approvals as of mid-November*. Seven novel antibody therapeutics (begelomab, brodalumab, elotuzumab, ixekizumab, necitumumab, obiltoxaximab, reslizumab) are in regulatory review, and thus a similar number, if not more, are projected to gain first approvals in 2016...
2016: MAbs
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