Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Virginia E. Kwitkowski"'
Autor:
R. Angelo de Claro, Paul G. Kluetz, Tanya Wroblewski, Virginia E. Kwitkowski, Ann T. Farrell, Thomas Gwise, Bellinda L King-Kallimanis, Vishal Bhatnagar
Publikováno v:
Quality of Life Research. 29:1903-1911
On August 2, 2017, the Food and Drug Administration approved ibrutinib (IMBRUVICA) for the treatment of patients with chronic graft versus host disease (cGVHD) after the failure of one or more lines of systemic therapy. The approval was based on resu
Autor:
Lola Luo, Yuan Li Shen, Kirsten B. Goldberg, Sriram Subramaniam, Amy E. McKee, Ann T. Farrell, Virginia E. Kwitkowski, Edvardas Kaminskas, Stacy S. Shord, Patricia A. Oneal, Richard Pazdur
Publikováno v:
The Oncologist
The FDA has granted regular approval to vemurafenib for the treatment of adult patients with Erdheim‐Chester Disease (ECD) with BRAFV600 mutation. This article describes the FDA review of the evidence and the clinical implications for this rare pat
Autor:
Ruben A. Mesa, Chad J. Gwaltney, Jean Paty, Virginia E. Kwitkowski, Lixia Wang, Joseph Feliciano, Stephen Joel Coons, Elektra J. Papadopoulos, Amylou C. Dueck
Publikováno v:
Leuk Res
Along with reducing spleen size, relieving symptom severity is a key objective of the treatment of myelofibrosis (MF). Several questionnaires have been developed for patient self-report of MF symptoms in clinical trials and each includes unique instr
Autor:
Bindu Kanapuru, Gideon M. Blumenthal, Harpreet Singh, Richard Pazdur, Virginia E. Kwitkowski, Ann T. Farrell
Publikováno v:
Blood reviews. 43
Despite a high incidence of hematologic malignancies in older adults, available data indicate that there is disproportionately low representation of adults ≥65 years with hematologic malignancies (greater in patients ≥75 years) in clinical trials
Autor:
Ann T. Farrell, Geoffrey Kim, Patricia Keegan, Laura Lee Johnson, Rajeshwari Sridhara, Elektra J. Papadopoulos, Wen-Hung Chen, Richard Pazdur, Martha Donoghue, Virginia E. Kwitkowski, Ashley F. Slagle, Paul G. Kluetz
Publikováno v:
Clinical Cancer Research. 22:1553-1558
Cancer clinical trials have relied on overall survival and measures of tumor growth or reduction to assess the efficacy of a drug. However, benefits are often accompanied by significant symptomatic toxicities. The degree to which a therapy improves d
Autor:
Xiao Hong Chen, M. Stacey Ricci, Hyon-Zu Lee, Yuan Li Shen, Richard Pazdur, Julie Bullock, Sarah E. Dorff, Rosane Charlab, Haleh Saber, Bahru A. Habtemariam, Robert C. Kane, Robert Justice, Edvardas Kaminskas, Virginia E. Kwitkowski, Erik Bloomquist, Ann T. Farrell, Nitin Mehrotra, Pedro L. Del Valle, Janice Brown
Publikováno v:
Clinical Cancer Research. 21:2666-2670
On July 3, 2014, the FDA granted accelerated approval for belinostat (Beleodaq; Spectrum Pharmaceuticals, Inc.), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). A single-ar
Publikováno v:
Clinical trials (London, England). 14(6)
Autor:
Hyon-Zu Lee, Edvardas Kaminskas, Barry W. Miller, Richard Pazdur, Robert C. Kane, Robert Justice, Lei Nie, Pedro DelValle, Chia-Wen Ko, Stacey Ricci, Virginia E. Kwitkowski, Nitin Mehrotra, Joseph A. Grillo, Marjorie A. Shapiro, Haleh Saber, Julie Bullock, Ann T. Farrell, Jeffry Florian, Mate Tolnay
Publikováno v:
Clinical Cancer Research. 20:3902-3907
On November 1, 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab (GAZYVA; Genentech, Inc.), a CD20-directed cytolytic antibody, for use in combination with chlorambucil for the treatment of patients with previously untreated chr
Autor:
Mark D. Rothmann, Elsbeth Chikhale, Robert C. Kane, Julie Bullock, Erika Pfeiler, Edvardas Kaminskas, Haleh Saber, Janice Brown, Joseph A. Grillo, Richard Pazdur, Ann T. Farrell, Firoozeh Alvandi, Chia-Wen Ko, Virginia E. Kwitkowski, Stacey Ricci, Debasis Ghosh
Publikováno v:
The Oncologist. 19:94-99
On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chr
Autor:
Xiao Hong Chen, Yanli Ouyang, Janice Brown, Kyung Y. Lee, Haleh Saber, Karen M. McGinn, Kallappa Koti, Julie Bullock, Lara Akinsanya, Kathleen A. Clouse, Virginia E. Kwitkowski, Franciso Borrego, Edvardas Kaminskas, Ann T. Farrell, Marjorie A. Shapiro, Mark D. Rothmann, Richard Pazdur, Aakanksha Khandelwal, Bahru A. Habtemariam, R. Angelo de Claro, Robert C. Kane
Publikováno v:
Clinical Cancer Research. 18:5845-5849
The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm