Zobrazeno 1 - 10
of 35
pro vyhledávání: '"Martha Donoghue"'
Autor:
Thomas G. Biel, Svetlana Petrovskaya, Francesca Mascia, Tongzhong Ju, Lola Fashoyin-Aje, Kelly M. Herremans, Andrea N. Riner, Patrick W. Underwood, Michael H. Gerber, Martha Donoghue, Jose G. Trevino, V. Ashutosh Rao
Publikováno v:
PLoS ONE, Vol 18, Iss 2 (2023)
In pancreatic cancer clinical trials, Black patients are under-represented while having higher morbidity and mortality rates as compared to other racial groups. Multiple factors, including socioeconomic and lifestyle factors may contribute to this di
Externí odkaz:
https://doaj.org/article/7d78001b4d024ea098ffacad19dadd38
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
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
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
Autor:
Timil H. Patel, Leigh Marcus, M. Naomi Horiba, Martha Donoghue, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Robert N. Schuck, Yangbing Li, Xinyuan Zhang, Jeanne Fourie Zirkelbach, Rosane Charlab, Jiang Liu, Yuching Yang, Steven J. Lemery, Richard Pazdur, Marc R. Theoret, Lola A. Fashoyin-Aje
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research.
On April 17, 2020, the FDA granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other re
Autor:
Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research.
On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 in
Autor:
Martha Donoghue, Rajeshwari Sridhara, Mallorie H. Fiero, Julia A. Beaver, Lola Fashoyin-Aje, Nicole J. Gormley, Shenghui Tang, Laleh Amiri-Kordestani, R. Angelo de Claro, Amna Ibrahim, Anup K. Amatya, Richard Pazdur, Erik Bloomquist, Arup K. Sinha, Steven Lemery, Harpreet Singh, Marc R. Theoret, Paul G. Kluetz
Publikováno v:
Clin Cancer Res
Subgroup analyses are assessments of treatment effects based on certain patient characteristics out of the total study population and are important for interpretation of pivotal oncology trials. However, appropriate use of subgroup analyses results f
Autor:
Patricia Keegan, Jennifer J Gao, Martha Donoghue, Stacy Shifflett Shord, Abhilasha Nair, Richard Pazdur, Elleni Alebachew, William F. Pierce, Laurie B. Burke, R. Donald Harvey, George D. Demetri, Joohee Sul, Janice Kim, Harvey Katzen, Katherine Anne Thornton, Paul G. Kluetz, Sundeep Agrawal
Publikováno v:
Clinical Cancer Research. 27:916-921
The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result of this process, FDA-approved product labeling is generated that is considered one of the most
Autor:
Hong Zhao, Whitney S. Helms, Richard Pazdur, Leigh Marcus, Martha Donoghue, Guoxiang Shen, Patricia Keegan, Stephanie Aungst, Olen Stephens, Claire E. Myers
Publikováno v:
Clinical Cancer Research. 27:928-932
The FDA-approved entrectinib on August 15, 2019, for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mu
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)