Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Sandra, Casak"'
Autor:
David J. Pinato, Xiaoxue Li, Pallavi Mishra-Kalyani, Antonio D’Alessio, Claudia A.M. Fulgenzi, Bernhard Scheiner, Matthias Pinter, Guo Wei, Julie Schneider, Donna R. Rivera, Richard Pazdur, Marc R. Theoret, Sandra Casak, Steven Lemery, Lola Fashoyin-Aje, Alessio Cortellini, Lorraine Pelosof
Publikováno v:
JHEP Reports, Vol 5, Iss 6, Pp 100747- (2023)
Background & Aims: Immune checkpoint inhibitors (ICIs) alone or in combination with other ICIs or vascular endothelial growth factor pathway inhibitors are therapeutic options in unresectable/metastatic hepatocellular carcinoma (HCC). Whether antibio
Externí odkaz:
https://doaj.org/article/6927577eae4849a9b007d6bf4469b648
Autor:
Steven Lemery, Lola Fashoyin-Aje, Leigh Marcus, Sandra Casak, Julie Schneider, Marc Theoret, Paul Kluetz, Richard Pazdur, Julia A. Beaver
Publikováno v:
Annual Review of Cancer Biology. 6:147-165
In 2017 the FDA (US Food and Drug Administration) approved pembrolizumab, a programmed death 1 (PD-1) inhibitor, for the treatment of unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0b63bd985c5b6552e0d295b307c6a8dc
https://doi.org/10.1146/annurev-cancerbio-060921-021828
https://doi.org/10.1146/annurev-cancerbio-060921-021828
Autor:
Sirisha Mushti, Lola Fashoyin-Aje, Steven Lemery, Marc R. Theoret, Kirsten B. Goldberg, Joyce Cheng, Lorraine Pelosof, May Tun Saung, Xiling Jiang, Richard Pazdur, Martha Donoghue, Jiang Liu, Sandra Casak, Maryam Khazraee, Hong Zhao
Publikováno v:
Oncologist
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (OPDIVO; Bristol Myers Squibb, New York, NY) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::766473e2ccf3c3137bcb8ffa612dedbc
https://doi.org/10.1002/onco.13646
https://doi.org/10.1002/onco.13646
Autor:
Kirsten B. Goldberg, Lola Fashoyin-Aje, William F. Pierce, Marc R. Theoret, Sirisha Mushti, Paul G. Kluetz, Richard Pazdur, Yuan Li Shen, Leah Her, Leigh Marcus, Sandra Casak, Steven Lemery, Joyce Cheng
Publikováno v:
Clin Cancer Res
The FDA approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer with no prior systemic treatment for advanced disease. The approval was based on
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::363be90aa542b7139583b6586788a137
https://pubmed.ncbi.nlm.nih.gov/33846198
https://pubmed.ncbi.nlm.nih.gov/33846198
Autor:
Kirsten B. Goldberg, Steven Lemery, Lisa Rodriguez, Lorraine Pelosof, Richard Pazdur, Meredith K. Chuk, May Tun Saung, Marc R. Theoret, Mengdie Yuan, Sandra Casak, Peter Schotland, Lola Fashoyin-Aje, Gina Davis, Martha Donoghue
Publikováno v:
Oncologist
On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab in combination with ipilimumab for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib. The recommend
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::46f6d4a83fd727570e61cf2b7eadb30c
https://pubmed.ncbi.nlm.nih.gov/33973307
https://pubmed.ncbi.nlm.nih.gov/33973307
Autor:
Hong Zhao, Lisa Rodriguez, Kirsten B. Goldberg, Lola Fashoyin-Aje, Jiang Liu, Yuan Xu, Richard Pazdur, Yuan Li Shen, Sandra Casak, Martha Donoghue, Marc R. Theoret, Xiling Jiang, Shubhangi Mehta, Steven Lemery, Xiaoping Jiang, Paul G. Kluetz, William F. Pierce
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 27(7)
On May 29, 2020, the FDA approved atezolizumab for use in combination with bevacizumab, for the treatment of adult patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior systemic treatment. The approval
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::82cc7ce9574cc56876fb6107c4453d8f
https://pubmed.ncbi.nlm.nih.gov/33472912
https://pubmed.ncbi.nlm.nih.gov/33472912
Autor:
Steven Lemery, Vadryn Pierre, Kirsten B. Goldberg, Richard Pazdur, Lisa Rodriguez, Anuja Patel, Youwei Bi, Sandra Casak, Lorraine Pelosof, Jeanne Fourie Zirkelbach, Amy E. McKee, Xiaoping Jiang, Jiang Liu, Patricia Keegan
Publikováno v:
The Oncologist
Regorafenib is the first drug approved by the FDA for the treatment of hepatocellular carcinoma that has progressed on sorafenib and is expected to become a standard of care for these patients. This article summarizes the FDA's review of the data sub
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::678ff9134b96d7f8a272925b3ba731ff
https://doi.org/10.1634/theoncologist.2017-0422
https://doi.org/10.1634/theoncologist.2017-0422
Autor:
Patricia Keegan, Thomas Gwise, Steven Lemery, Kun He, Rajeshwari Sridhara, Richard Pazdur, Sandra Casak, Huanyu Chen
Publikováno v:
Clinical Cancer Research. 22:5167-5170
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established an abbreviated approval pathway for biosimilar and interchangeable biological products that was intended to balance innovation and consumer interests. The FDA has publi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::72f30d18c0ebe03f9a35881d1d978ce6
https://doi.org/10.1158/1078-0432.ccr-16-1010
https://doi.org/10.1158/1078-0432.ccr-16-1010
Publikováno v:
Clinical Cancer Research. 22:2111-2113
Sponsors of human drug and biologic products subject to an investigational new drug (IND) application are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and the FDA
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58c3cd992f0c454ce47dac10857488a1
https://doi.org/10.1158/1078-0432.ccr-15-2082
https://doi.org/10.1158/1078-0432.ccr-15-2082
Autor:
Richard Pazdur, Hong Zhao, Steven Lemery, Vaishali Jarral, Sandra Casak, Yuan Li Shen, Patricia Keegan, Aakanksha Khandelwal, Gina Davis, Mark D. Rothmann
Publikováno v:
The Oncologist. 16:97-104
Learning Objectives After completing this course, the reader will be able to: Compare the survival benefits of rituximab in combination with fludarabine and cyclophosphamide to those of alemtuzumab, bendamustine, and ofatumumab in patients with CLL.I
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5fa9162a53c24fadfa9dcc05443c971d
https://doi.org/10.1634/theoncologist.2010-0306
https://doi.org/10.1634/theoncologist.2010-0306