Zobrazeno 1 - 10
of 19
pro vyhledávání: '"Diana Bradford"'
Autor:
Jaleh Fallah, Michael H. Brave, Chana Weinstock, Gautam U. Mehta, Diana Bradford, Haley Gittleman, Erik W. Bloomquist, Rosane Charlab, Salaheldin S. Hamed, Claudia P. Miller, Sarah E. Dorff, Wiley A. Chambers, Bronwyn D. Mixter, Jeannette Dinin, William F. Pierce, Tiffany K. Ricks, Shenghui Tang, Martha Donoghue, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Julia A. Beaver
Publikováno v:
Clin Cancer Res
On August 13, 2021, the FDA approved belzutifan (WELIREG, Merck), a first-in-class hypoxia-inducible factor (HIF) inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5d366bff8662137a824aa2634279d526
https://doi.org/10.1158/1078-0432.ccr-22-1054
https://doi.org/10.1158/1078-0432.ccr-22-1054
Autor:
Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S. L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh
Publikováno v:
Clinical Cancer Research.
On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for the treatment of adult patients with locally advanced or metastatic solid tumors with a rearranged
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8672b668b5c656a9b30b7d69b31a086a
https://doi.org/10.1158/1078-0432.ccr-23-0459
https://doi.org/10.1158/1078-0432.ccr-23-0459
Autor:
Harpreet Singh, Marc R. Theoret, Richard Pazdur, Julia A. Beaver, Paul G. Kluetz, Shenghui Tang, Autumn Zack-Taylor, Reena Philip, Donna Roscoe, Soma Ghosh, Dun Liang, Francisca Reyes Turcu, Rosane Charlab, Jiang Liu, Yangbing Li, Jeanne Fourie Zirkelbach, Lauren S.L. Price, Whitney S. Helms, Amy M. Skinner, Lisa Rodriguez, Sirisha L. Mushti, Erin Larkins, Diana Bradford
On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), (ii) adult and pediatric patients ≥12 years of age with advanced or metastatic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::be7343eb8f94d802c06ee615ed48b00e
https://doi.org/10.1158/1078-0432.c.6531198.v1
https://doi.org/10.1158/1078-0432.c.6531198.v1
Autor:
Harpreet Singh, Julia A. Beaver, Marc R. Theoret, Richard Pazdur, Reena Philip, Soma Ghosh, Dun Liang, Hong Zhao, Jiang Liu, Rosane Charlab, Jielin Sun, Youwei Bi, Amal Ayyoub, Whitney S. Helms, Emily Wearne, Pallavi S. Mishra-Kalyani, Somak Chatterjee, Lee H. Pai-Scherf, Erin Larkins, Diana Bradford, Janice Kim
Supplementary Tables S1-S3
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3e4b5d26de3d7ddf0a7029f07d3d7773
https://doi.org/10.1158/1078-0432.22481316.v1
https://doi.org/10.1158/1078-0432.22481316.v1
Autor:
Harpreet Singh, Marc R. Theoret, Richard Pazdur, Julia A. Beaver, Paul G. Kluetz, Shenghui Tang, Autumn Zack-Taylor, Reena Philip, Donna Roscoe, Soma Ghosh, Dun Liang, Francisca Reyes Turcu, Rosane Charlab, Jiang Liu, Yangbing Li, Jeanne Fourie Zirkelbach, Lauren S.L. Price, Whitney S. Helms, Amy M. Skinner, Lisa Rodriguez, Sirisha L. Mushti, Erin Larkins, Diana Bradford
Supplementary Tables 1 - 3
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b1bec6ad892cdfcb192e429eefae90a
https://doi.org/10.1158/1078-0432.22483665.v1
https://doi.org/10.1158/1078-0432.22483665.v1
Publikováno v:
Current opinion in pediatrics. 35(1)
We describe select recent FDA approvals in pediatric cancers and rare tumors, and the unique regulatory considerations raised by each application.The approvals of naxitamab, selumetinib, selpercatinib, and crizotinib for pediatric and adolescent pati
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4d37cf3fe799f376ce538d9a53f52d86
https://pubmed.ncbi.nlm.nih.gov/36592026
https://pubmed.ncbi.nlm.nih.gov/36592026
Autor:
Lynley V. Marshall, Brenda J. Weigel, G. Lesa, Joe McDonough, Malcolm A. Smith, Gudrun Schleiermacher, Nick Bird, Franca Ligas, Elly Barry, Yael P. Mosse, D Valteau, Eric J. Lowe, Nicholas Richardson, François Doz, Meredith S. Irwin, Zachary Franklin Zimmerman, Toby Trahair, Koen Norga, Sonia Singh, Martha Donoghue, Steven G. DuBois, Susan L. Weiner, Michela Casanova, Giovanni Selvaggi, Andrew D.J. Pearson, Dominik Karres, Yousif Matloub, Keith D. Wilner, Teresa de Rojas, Nicole Scobie, Rajkumar Venkatramani, Gilles Vassal, H.N. Caron, Amar Gajjar, Amy Barone, Patricia Blanc, Margret Merino, Diana Bradford, Gregory H. Reaman, Willi Woessmann, Elizabeth Fox, Vickie Buenger, Julie Park, Karsten Nysom
Publikováno v:
European Journal of Cancer. 157:198-213
The first (2017) and sixth (2021) multistakeholder Paediatric Strategy Forums focused on anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies. ALK is an important oncogene and target in several paediatric tumours (anaplastic large c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::20a27456377fec5606ed5dc5201b2b93
https://doi.org/10.1016/j.ejca.2021.08.022
https://doi.org/10.1016/j.ejca.2021.08.022
Autor:
Harpreet Singh, Laleh Amiri-Kordestani, Amy Barone, Richard Pazdur, Mirat Shah, Janice Kim, Suparna Wedam, Diana Bradford, Gautam U Mehta, Erin Larkins, Adnan A. Jaigirdar, Marc R. Theoret, Lee Pai-Scherf, Julia A. Beaver
Publikováno v:
Journal of Neuro-Oncology
Objective Contemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug Administration (FDA) related to nervous system tumors. To summarize FDA updates applicable to neuro-oncology pra
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a6804ad5907e81dfa5697028411582c
https://doi.org/10.1007/s11060-021-03789-5
https://doi.org/10.1007/s11060-021-03789-5
Autor:
Janice Kim, Diana Bradford, Erin Larkins, Lee H. Pai-Scherf, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Emily Wearne, Whitney S. Helms, Amal Ayyoub, Youwei Bi, Jielin Sun, Rosane Charlab, Jiang Liu, Hong Zhao, Dun Liang, Soma Ghosh, Reena Philip, Richard Pazdur, Marc R. Theoret, Julia A. Beaver, Harpreet Singh
Publikováno v:
Clinical Cancer Research. 27:5452-5456
The FDA granted accelerated approval for pralsetinib on September 4, 2020 for non–small cell lung cancer (NSCLC) and December 1, 2020 for thyroid cancer, for: (i) adult patients with metastatic RET fusion–positive NSCLC, (ii) adult and pediatric
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ffa3f02843d33f5662a70e29c68838da
https://doi.org/10.1158/1078-0432.ccr-21-0967
https://doi.org/10.1158/1078-0432.ccr-21-0967
Autor:
Julia A. Beaver, Whitney S. Helms, Harpreet Singh, Jiang Liu, Reena Philip, Diana Bradford, Dun Liang, Francisca Reyes Turcu, Amy M. Skinner, Rosane Charlab, Shenghui Tang, Soma Ghosh, Lauren S. L. Price, Marc R. Theoret, Richard Pazdur, Erin Larkins, Donna Roscoe, Yangbing Li, Jeanne Fourie Zirkelbach, Sirisha Mushti, Autumn Zack-Taylor, Lisa Rodriguez, Paul G. Kluetz
Publikováno v:
Clinical Cancer Research. 27:2130-2135
On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), (ii) adult and pediatric patients ≥12 years of age with advanced or metastatic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::842813bad208e8eb140a01e30788d85c
https://doi.org/10.1158/1078-0432.ccr-20-3558
https://doi.org/10.1158/1078-0432.ccr-20-3558