Výsledky vyhledávání - "Theresa Carioti"

Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective

Autor: Andrea C. Baines, Maryam Sarraf Yazdy, Yvette L. Kasamon, Rachel Ershler, Emily Y. Jen, Bindu Kanapuru, Nicholas C. Richardson, Ashley Lane, Theresa Carioti, Marc R. Theoret, Richard Pazdur, Nicole J. Gormley

Publikováno v: Clinical Cancer Research. :OF1-OF5

Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data in registrational trials in hem

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::fcf9a252dba78f07c5411f52094b4931
https://doi.org/10.1158/1078-0432.ccr-22-3579

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Minimal Residual Disease (MRD) Data in Hematologic Malignancy Drug Applications and Prescribing Information: FDA Analysis

Autor: Marc R. Theoret, Yvette L. Kasamon, Andrea C. Baines, Emily Y. Jen, Rachel Ershler, Bindu Kanapuru, Nicholas Richardson, Theresa Carioti, Maryam Sarraf Yazdy, Ashley Lane, Nicole J. Gormley

Publikováno v: Blood. 138:4928-4928

Introduction: In the past decade, multiple studies have reported the prognostic and predictive value of MRD status in specific hematologic malignancies (HM). Because clinical trials are increasingly incorporating MRD status as a biomarker and efficac

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c43e7cff3b85b943c6d1243156f2dce5
https://doi.org/10.1182/blood-2021-150446

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FDA Analysis of Survival Outcomes in Older Adults with Relapsed-Refractory Multiple Myeloma (RRMM) Treated with Novel Drug Regimens

Autor: Ann T. Farrell, Susan Jin, Theresa Carioti, Kunthel By, Bindu Kanapuru, Rajeshwari Sridhara, Nicole J. Gormley, Richard Pazdur, Yuan-Li Shen

Publikováno v: Blood. 134:3194-3194

Background: Multiple novel therapies have been approved for the treatment of RRMM in recent years, resulting in improvements in progression free survival (PFS) and overall survival (OS). However, clinical trials in MM often enroll only a small propor

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::4531d04473de1380af48e832a920849b
https://doi.org/10.1182/blood-2019-127141

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FDA Analysis of Outcomes in Older Adults with Relapsed or Refractory Multiple Myeloma

Autor: Kunthel By, Nicole J. Gormley, Susan Jin, Bindu Kanapuru, Richard Pazdur, Theresa Carioti, Yuan Li Shen, Ann T. Farrell

Publikováno v: Blood. 132:3287-3287

Background: Multiple myeloma (MM) is a disease of older adults with a median age of onset of 70 years. Approximately 20% of the incident cases are diagnosed in patients 85 years and older. There is significant heterogeneity among older adults with re

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::40a4d02fd8c4cf9c4ede9ed64dccc140
https://doi.org/10.1182/blood-2018-99-118597

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FDA analysis of pembrolizumab trials in multiple myeloma: Immune related adverse events (irAEs) and response

Autor: Kimberly Scott, Nicole J. Gormley, Richard Pazdur, Flora Mulkey, Theresa Carioti, Barry W. Miller, Rajeshwari Sridhara, Aviva C. Krauss, Yuan-Li Shen, Ann T. Farrell, Amy S. Rosenberg, Marc R. Theoret

Publikováno v: Journal of Clinical Oncology. 36:8008-8008

8008Background: Development of irAEs with checkpoint inhibition may be associated with response in some disease settings. Methods: We evaluated overall survival (OS), safety and objective response ...

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::cda43a0e5f74ababffeeaf58ca259349
https://doi.org/10.1200/jco.2018.36.15_suppl.8008

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