Zobrazeno 1 - 10
of 24
pro vyhledávání: '"Emily Y. Jen"'
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
https://doi.org/10.1158/1078-0432.ccr-22-3579
Autor:
Mikkael A. Sekeres, Nina Kim, Amy E. DeZern, Kelly J. Norsworthy, Jacqueline S. Garcia, R. Angelo de Claro, Marc R. Theoret, Emily Y. Jen, Lori A. Ehrlich, Amer M. Zeidan, Rami S. Komrokji
Publikováno v:
Clinical Cancer Research. :OF1-OF7
Myelodysplastic syndromes (MDS) have historically been challenging diseases for drug development due to their biology, preclinical modeling, and the affected patient population. In April 2022, the FDA convened a panel of regulators and academic exper
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c352e0dbb06a72c48acb8bede57cf850
https://doi.org/10.1158/1078-0432.ccr-22-3348
https://doi.org/10.1158/1078-0432.ccr-22-3348
Autor:
Richard Pazdur, Ann T. Farrell, Reena Philip, Albert Deisseroth, Rajeshwari Sridhara, Donna Roscoe, Yuan Li Shen, Donna Przepiorka, Aaron Schetter, Qing Xu, Emily Y. Jen
Grouped terms used in safety analyses
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4bb3c71a1ae3311a34043cbf269cfa88
https://doi.org/10.1158/1078-0432.22474197.v1
https://doi.org/10.1158/1078-0432.22474197.v1
Autor:
Richard Pazdur, Ann T. Farrell, Reena Philip, Albert Deisseroth, Rajeshwari Sridhara, Donna Roscoe, Yuan Li Shen, Donna Przepiorka, Aaron Schetter, Qing Xu, Emily Y. Jen
On March 29, 2018, the FDA granted accelerated approval for blinatumomab (Blincyto; Amgen, Inc.) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (BCP ALL) in first or second complete remission with minimal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4633f148f2828c48b9597e5e86f99f2c
https://doi.org/10.1158/1078-0432.c.6528714
https://doi.org/10.1158/1078-0432.c.6528714
Autor:
Richard Pazdur, Ann T. Farrell, Reena Philip, Albert Deisseroth, Rajeshwari Sridhara, Donna Roscoe, Yuan Li Shen, Donna Przepiorka, Aaron Schetter, Qing Xu, Emily Y. Jen
RFS by baseline MRD level from Study 20120148
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::39411af126f6f2d40456d9d1f9609510
https://doi.org/10.1158/1078-0432.22474200
https://doi.org/10.1158/1078-0432.22474200
Autor:
Richard Pazdur, Ann T. Farrell, Marjorie Shapiro, Christopher M. Sheth, Jiang Liu, Lei Nie, Donna Przepiorka, Kelly J. Norsworthy, Charles Jewell, Antonina Aydanian, Pedro L. Del Valle, Jee Eun Lee, Chia-Wen Ko, Emily Y. Jen
Supplemental Table 1 describes the adverse events with corresponding risk differences between treatment arms during induction of pivotal trial ALFA-0701.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5bd7a67b15c996ac2b4ce4780a377946
https://doi.org/10.1158/1078-0432.22470144
https://doi.org/10.1158/1078-0432.22470144
Autor:
Richard Pazdur, Ann T. Farrell, Marjorie Shapiro, Christopher M. Sheth, Jiang Liu, Lei Nie, Donna Przepiorka, Kelly J. Norsworthy, Charles Jewell, Antonina Aydanian, Pedro L. Del Valle, Jee Eun Lee, Chia-Wen Ko, Emily Y. Jen
On September 1, 2017, the FDA granted approval for gemtuzumab ozogamicin (Mylotarg; Pfizer Inc.) in combination with daunorubicin and cytarabine and as a monotherapy for the treatment of adult patients with newly diagnosed CD33-positive acute myeloid
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0a3057e773121d0976ff70e8b3c1217f
https://doi.org/10.1158/1078-0432.c.6527439.v1
https://doi.org/10.1158/1078-0432.c.6527439.v1
Autor:
Richard Pazdur, Ann T. Farrell, Marjorie Shapiro, Christopher M. Sheth, Jiang Liu, Lei Nie, Donna Przepiorka, Kelly J. Norsworthy, Charles Jewell, Antonina Aydanian, Pedro L. Del Valle, Jee Eun Lee, Chia-Wen Ko, Emily Y. Jen
Supplemental Table 4 and the accompanying text describe the grouped terms used for the adverse reactions described in Table 2 and the reasons for using grouped terms.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6bfa00162775f4396f1aa89b2c0e5fca
https://doi.org/10.1158/1078-0432.22470135.v1
https://doi.org/10.1158/1078-0432.22470135.v1
Autor:
Richard Pazdur, Gideon M. Blumenthal, Ann T. Farrell, Kirsten B. Goldberg, Steven Bowen, Christopher M. Sheth, Chao Liu, Ruby Leong, Yuan Li Shen, Donna Przepiorka, Rong Wang, Baikuntha Aryal, Natalie E. Simpson, Luning Zhuang, Liang Li, Xin Gao, Emily Y. Jen
Supplementary Table 1 contains FDA's screening algorithm for capillary leak syndrome (CLS).
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::23ed8d0ff75dab154150f0380e96edf0
https://doi.org/10.1158/1078-0432.22476914.v1
https://doi.org/10.1158/1078-0432.22476914.v1
Autor:
Richard Pazdur, Ann T. Farrell, Reena Philip, Albert Deisseroth, Rajeshwari Sridhara, Donna Roscoe, Yuan Li Shen, Donna Przepiorka, Aaron Schetter, Qing Xu, Emily Y. Jen
Grade >/= 3 AR
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c6276fd3c35307dfac0d1990907313a
https://doi.org/10.1158/1078-0432.22474191
https://doi.org/10.1158/1078-0432.22474191