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brentuximab vedotin

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https://www.readbyqxmd.com/read/29343970/a-retrospective-examination-of-the-us-food-and-drug-administration-s-clinical-pharmacology-reviews-of-oncology-biologics-for-potential-use-of-therapeutic-drug-monitoring
#1
Brett Fleisher, Sihem Ait-Oudhia
Background: Biologics have gained traction for use in oncology, but have demonstrate clinical variability for efficacy and safety. Therapeutic drug monitoring (TDM) can benefit patients' outcomes from a biologic therapy when the latter has a defined therapeutic window. A clinically relevant therapeutic window may exist for biologics with established exposure-response (E-R) relationships for efficacy and/or safety and a documented maximum tolerated dose (MTD). Additionally, the inter-individual variability (IIV) on the clearance (CL) parameter could determine risks for patients falling outside the proposed therapeutic window...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29334819/management-of-hodgkin-lymphoma-in-the-era-of-brentuximab-vedotin-real-world-data-from-five-european-countries
#2
Graham P Collins, Antonio Rueda, Gilles Salles, Bastian von Tresckow, Francesco Zaja
We examined real-world data on management of relapsed/refractory Hodgkin lymphoma (R/R HL) in five European countries and the consistency of these data with guideline recommendations. Retrospective clinical and epidemiologic data for 509 patients with R/R HL treated between January 2014 and March 2015 were collected at centers in France, Germany, Italy, Spain, and the United Kingdom. Mean age was 46.3 years; 73.3% were receiving second-line therapy for a first relapse during the reporting period. Most patients received ABVD as front-line chemotherapy, except in Germany where escalated BEACOPP was used more often...
January 16, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29333400/brentuximab-vedotin-clinical-updates-and-practical-guidance
#3
REVIEW
Jun Ho Yi, Seok Jin Kim, Won Seog Kim
Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. Owing to the remarkable efficacy shown in CD30-positive lymphomas, such as Hodgkin's lymphoma and systemic anaplastic large-cell lymphoma, BV was granted accelerated approval in 2011 by the US Food and Drug Administration. Thereafter, many large-scale trials in various situations have been performed, which led to extensions of the original indication. The aim of this review was to describe the latest updates on clinical trials of BV and the in-practice guidance for the use of BV...
December 2017: Blood Research
https://www.readbyqxmd.com/read/29313932/brentuximab-vedotin-is-an-effective-therapy-for-cd30-mycosis-fungoides-and-cutaneous-anaplastic-large-cell-lymphoma-what-is-the-cost
#4
J J Scarisbrick
No abstract text is available yet for this article.
December 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29280762/brentuximab-vedotin-with-avd-shows-safety-in-the-absence-of-strong-cyp3a4-inhibitors-in-newly-diagnosed-hiv-associated-hodgkin-lymphoma
#5
Paul G Rubinstein, Page C Moore, Michelle A Rudek, David H Henry, Juan C Ramos, Lee Ratner, Erin Reid, Elad Sharon, Ariela Noy
OBJECTIVE: Brentuximab vedotin (BV) is an FDA approved anti-CD30 antibody drug conjugate potently active in Hodgkin lymphoma (HL). Trials of BV with doxorubicin, vinblastine, and dacarbazine (AVD-BV) excluded patients with HIV. We studied the safety of (AVD-BV) in newly diagnosed HIV-associated classical Hodgkin lymphoma (HIV-cHL). DESIGN AND METHODS: Patients diagnosed with Stage II-IV HIV-cHL received AVD-BV on days 1 and 15 every 28 days for 6 cycles. Anti-HIV medications with strong CYP3A4 inhibition were excluded...
December 26, 2017: AIDS
https://www.readbyqxmd.com/read/29279550/anaplastic-large-cell-lymphoma-pathology-genetics-and-clinical-aspects
#6
Naoko Tsuyama, Kana Sakamoto, Seiji Sakata, Akito Dobashi, Kengo Takeuchi
Anaplastic large cell lymphoma (ALCL) was first described in 1985 as a large-cell neoplasm with anaplastic morphology immunostained by the Ki-1 antibody, which recognizes CD30. In 1994, the nucleophosmin (NPM)-anaplastic lymphoma kinase (ALK) fusion receptor tyrosine kinase was identified in a subset of patients, leading to subdivision of this disease into ALK-positive and -negative ALCL in the present World Health Organization classification. Due to variations in morphology and immunophenotype, which may sometimes be atypical for lymphoma, many differential diagnoses should be considered, including solid cancers, lymphomas, and reactive processes...
2017: Journal of Clinical and Experimental Hematopathology: JCEH
https://www.readbyqxmd.com/read/29276023/salvage-regimens-for-hodgkin-s-lymphoma-in-the-brentuximab-vedotin-era
#7
Umberto Vitolo, Annalisa Chiappella
No abstract text is available yet for this article.
December 21, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29276022/brentuximab-vedotin-plus-bendamustine-in-relapsed-or-refractory-hodgkin-s-lymphoma-an-international-multicentre-single-arm-phase-1-2-trial
#8
Owen A O'Connor, Jennifer K Lue, Ahmed Sawas, Jennifer E Amengual, Changchun Deng, Matko Kalac, Lorenzo Falchi, Enrica Marchi, Ithamar Turenne, Renee Lichtenstein, Celeste Rojas, Mark Francescone, Lawrence Schwartz, Bin Cheng, Kerry J Savage, Diego Villa, Michael Crump, Anca Prica, Vishal Kukreti, Serge Cremers, Joseph M Connors, John Kurvuilla
BACKGROUND: Brentuximab vedotin is currently approved for patients with relapsed or refractory Hodgkin's lymphoma who previously received an autologous stem cell transplant or two previous multiagent chemotherapy regimens, and for patients with relapsed or refractory systemic anaplastic large-T-cell lymphoma who previously received at least one chemotherapy regimen. A high proportion of patients with CD30-expressing relapsed or refractory lymphomas have durable responses to single-agent brentuximab vedotin and show longer progression-free survival than do patients treated with chemotherapy...
December 21, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29239690/antibody-drug-conjugates-design-and-development-for-therapy-and-imaging-in-and-beyond-cancer-labex-mabimprove-industrial-workshop-july-27-28-2017-tours-france
#9
Camille Martin, Claire Kizlik-Masson, André Pèlegrin, Hervé Watier, Marie-Claude Viaud-Massuard, Nicolas Joubert
The annual "Antibody Industrial Symposium", co organized by LabEx MAbImprove, MabDesign and Polepharma, was held in Tours, France on June 27-28, 2017. The focus was on antibody-drug-conjugates (ADCs), new entities which realize the hope of Paul Ehrlich's magic bullet. ADCs result from the bioconjugation of a highly cytotoxic drug to a selective monoclonal antibody, which acts as a vector. Building on knowledge gained during the development of three approved ADCs, brentuximab vedotin (Adcetris®), ado trastuzumab emtansine (Kadcyla®) and inotuzumab ozogamicin (Besponsa®), and the many ADCs in development, this meeting addressed strategies and the latest innovations in the field from fundamental research to manufacturing...
December 14, 2017: MAbs
https://www.readbyqxmd.com/read/29236132/brentuximab-vedotin-maintenance-following-chemotherapy-without-irradiation-for-primary-intracranial-embryonal-carcinoma-in-down-syndrome
#10
Mohammad H Abu Arja, Suzanne E Conley, Violeta Salceda, Fahd Al-Sufiani, Daniel R Boué, Jonathan L Finlay
BACKGROUND: Germ cell tumors (GCT) are the most common central nervous system (CNS) tumors in individuals with Down syndrome. Patients with Down syndrome treated with CNS irradiation are at increased risk of developing cerebrovascular complications such as moyamoya disease. Embryonal carcinoma components are recognized to be more resistant to conventional chemotherapy and radiotherapy and confer a very poor prognosis. CD30 is a member of the tumor necrosis factor-receptor superfamily...
December 13, 2017: Child's Nervous System: ChNS: Official Journal of the International Society for Pediatric Neurosurgery
https://www.readbyqxmd.com/read/29233742/how-to-approach-a-hodgkin-lymphoma-patient-with-relapse-after-autologous-sct-allogeneic-sct
#11
REVIEW
Matthew Mei, Robert Chen
Hodgkin lymphoma (HL) is a highly curable B-cell lymphoma, and ∼90% of patients who present with early-stage (stage I-II) disease and 70% of patients who present with late-stage disease will be cured with standard frontline treatment. For patients with relapsed or refractory (r/r) disease after initial therapy, the standard of care is salvage chemotherapy, followed by autologous transplantation (autoSCT). Although this approach will cure a significant proportion of patients, upto 50% of patients will experience disease progression after autoSCT, and this population has historically had a very poor prognosis...
December 9, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29229594/interim-results-of-brentuximab-vedotin-in-combination-with-nivolumab-in-patients-with-relapsed-or-refractory-hodgkin-lymphoma
#12
Alex F Herrera, Alison J Moskowitz, Nancy L Bartlett, Julie M Vose, Radhakrishnan Ramchandren, Tatyana A Feldman, Ann S LaCasce, Stephen M Ansell, Craig H Moskowitz, Keenan Fenton, Carol Anne Ogden, David Taft, Qu Zhang, Kazunobu Kato, Mary Campbell, Ranjana H Advani
In this phase 1/2 study, brentuximab vedotin (BV) and nivolumab (Nivo) administered in combination were evaluated as initial salvage therapy in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL) (ClinicalTrials.gov #NCT02572167). Patients received up to 4 cycles of combination treatment, with BV administered on Day 1 and Nivo on Day 8 of the first cycle. For Cycles 2-4, BV and Nivo were both administered on Day 1. Following study treatment, responses were evaluated by investigators per the 2014 Lugano classification, and patients could proceed to autologous stem cell transplantation (ASCT)...
December 11, 2017: Blood
https://www.readbyqxmd.com/read/29224502/brentuximab-vedotin-with-chemotherapy-for-stage-iii-or-iv-hodgkin-s-lymphoma
#13
Joseph M Connors, Wojciech Jurczak, David J Straus, Stephen M Ansell, Won S Kim, Andrea Gallamini, Anas Younes, Sergey Alekseev, Árpád Illés, Marco Picardi, Ewa Lech-Maranda, Yasuhiro Oki, Tatyana Feldman, Piotr Smolewski, Kerry J Savage, Nancy L Bartlett, Jan Walewski, Robert Chen, Radhakrishnan Ramchandren, Pier L Zinzani, David Cunningham, Andras Rosta, Neil C Josephson, Eric Song, Jessica Sachs, Rachael Liu, Hina A Jolin, Dirk Huebner, John Radford
Background Brentuximab vedotin is an anti-CD30 antibody-drug conjugate that has been approved for relapsed and refractory Hodgkin's lymphoma. Methods We conducted an open-label, multicenter, randomized phase 3 trial involving patients with previously untreated stage III or IV classic Hodgkin's lymphoma, in which 664 were assigned to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) and 670 were assigned to receive doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The primary end point was modified progression-free survival (the time to progression, death, or noncomplete response and use of subsequent anticancer therapy) as adjudicated by an independent review committee...
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29222273/emerging-role-of-novel-therapies-in-hodgkin-lymphoma-proceed-with-caution
#14
REVIEW
Nancy L Bartlett
Based on very high response rates in the relapsed and refractory setting, brentuximab vedotin and the programmed cell death protein 1 (PD-1) inhibitors, nivolumab and pembrolizumab, have quickly been incorporated into clinical trials for first- and second-line therapy of Hodgkin lymphoma. Preliminary data show that brentuximab vedotin alone is not adequate therapy for newly diagnosed Hodgkin lymphoma in older patients, but modestly decreases the risk of relapse when combined with adriamycin, vinblastine, and dacarbazine in patients with previously untreated advanced-stage disease...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29222199/treatment-of-cd30-expressing-germ-cell-tumors-and-sex-cord-stromal-tumors-with-brentuximab-vedotin-identification-and-report-of-seven-cases
#15
Costantine Albany, Lawrence Einhorn, Lawrence Garbo, Thomas Boyd, Neil Josephson, Darren R Feldman
BACKGROUND: Cytotoxic therapy for relapsed and refractory germ cell tumors or metastatic sex cord stromal tumors is rarely effective and is often accompanied by high adverse event rates. Expression of CD30 has been observed in testicular cancers, and patients with CD30-expressing embryonal carcinomas have worse progression-free survival and overall survival than those with CD30-negative tumors. The objective of this study (NCT01461538) was to characterize the antitumor activity of brentuximab vedotin in patients with CD30-expressing nonlymphomatous malignancies...
December 8, 2017: Oncologist
https://www.readbyqxmd.com/read/29207679/italian-real-life-experience-with-brentuximab-vedotin-results-of-a-large-observational-study-on-234-relapsed-refractory-hodgkin-s-lymphoma
#16
Cinzia Pellegrini, Alessandro Broccoli, Alessandro Pulsoni, Luigi Rigacci, Caterina Patti, Guido Gini, Donato Mannina, Monica Tani, Chiara Rusconi, Alessandra Romano, Anna Vanazzi, Barbara Botto, Armando Santoro, Stefan Hoaus, Gian Matteo Rigolin, Pellegrino Musto, Patrizio Mazza, Stefano Molica, Paolo Corradini, Angelo Fama, Francesco Gaudio, Michele Merli, Fioravante Ronconi, Giuseppe Gritti, Daniele Vallisa, Patrizia Tosi, Anna Marina Liberati, Antonello Pinto, Vincenzo Pavone, Filippo Gherlinzoni, Maria Paola Bianchi, Stefano Volpetti, Livio Trentin, Maria Cecilia Goldaniga, Maurizio Bonfichi, Amalia De Renzo, Corrado Schiavotto, Michele Spina, Angelo Michele Carella, Vittorio Stefoni, Lisa Argnani, Pier Luigi Zinzani
A large Italian multicenter observational retrospective study was conducted on the use of brentuximab vedotin (BV) for patients with relapsed Hodgkin's lymphoma (HL) to check if clinical trial results are confirmed even in a real life context. 234 CD30+ HL patients were enrolled. Best response was observed after a median of 4 cycles in 140 patients (59.8%): 74 (31.6%) patients obtained a complete response (CR) and 66 (28.2%) achieved a partial response (PR); overall response rate at the end of the treatment was 48...
October 31, 2017: Oncotarget
https://www.readbyqxmd.com/read/29188435/antibody-drug-conjugates-pharmacokinetic-pharmacodynamic-modeling-preclinical-characterization-clinical-studies-and-lessons-learned
#17
REVIEW
William D Hedrich, Tamer E Fandy, Hossam M Ashour, Hongbing Wang, Hazem E Hassan
Antibody-drug conjugates are an emerging class of biopharmaceuticals changing the landscape of targeted chemotherapy. These conjugates combine the target specificity of monoclonal antibodies with the anti-cancer activity of small-molecule therapeutics. Several antibody-drug conjugates have received approval for the treatment of various types of cancer including gemtuzumab ozogamicin (Mylotarg®), brentuximab vedotin (Adcetris®), trastuzumab emtansine (Kadcyla®), and inotuzumab ozogamicin, which recently received approval (Besponsa®)...
November 29, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29167875/treatment-of-cd30-negative-refractory-mycosis-fungoides-with-brentuximab-vedotin
#18
Connie Zhang, Manasmon Chairatchaneeboon, Paul Haun, Daniel Landsburg, Ellen J Kim
No abstract text is available yet for this article.
November 22, 2017: JAMA Dermatology
https://www.readbyqxmd.com/read/29165301/early-and-sustained-remission-with-brentuximab-vedotin-in-a-case-of-disseminated-cutaneous-relapse-from-systemic-anaplastic-large-cell-lymphoma-refractory-to-chemotherapy
#19
David Aguiar-Bujanda, Arancha Dueñas-Comino, Camila Cabello, Jesus Bastida, José Carlos Rivero-Vera, Miguel Angel Limeres-González
No abstract text is available yet for this article.
November 22, 2017: European Journal of Dermatology: EJD
https://www.readbyqxmd.com/read/29158727/near-complete-response-in-a-patient-with-classical-hodgkin-lymphoma-treated-with-brentuximab-vedotin-concurrent-with-radiation-therapy
#20
Wilbur Montana, Dennis Andrew Buck, Tristan Smith
Brentuximab vedotin, an antibody drug conjugate that delivers monomethyl auristatin E into CD-30 expressing cells is FDA approved for the treatment of patients with Hodgkin lymphoma after the failure of autologous stem cell transplantation or at least 2 prior multi-agent chemotherapy regiments. This approval was based on a study that showed an overall response rate of 75% and complete remission in 34%. We present a case of a 24-year-old male with classical nodular sclerosing Hodgkin lymphoma who achieved near complete remission following 5 cycles of brentuximab concurrent with ISRT (involved site radiation therapy) following progression of first-line ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) and subsequent second-line ICE (ifosfamide, carboplatin, etoposide) chemotherapy...
September 2017: Case Reports in Oncology
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