S
Shenghui Tang
Researcher at Center for Drug Evaluation and Research
Publications - 100
Citations - 8151
Shenghui Tang is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Medicine & Internal medicine. The author has an hindex of 34, co-authored 79 publications receiving 5812 citations. Previous affiliations of Shenghui Tang include Food and Drug Administration.
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Journal ArticleDOI
Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis
Patricia Cortazar,Lijun Zhang,Michael Untch,Keyur Mehta,Joseph P. Costantino,Norman Wolmark,Hervé Bonnefoi,David Cameron,Luca Gianni,Pinuccia Valagussa,Sandra M. Swain,Tatiana M. Prowell,Sibylle Loibl,D. Lawrence Wickerham,Jan Bogaerts,José Baselga,Charles M. Perou,Gideon M. Blumenthal,Jens Uwe Blohmer,Eleftherios P. Mamounas,Jonas Bergh,Vladimir Semiglazov,Robert Justice,Holger Eidtmann,Soonmyung Paik,Martine Piccart,Rajeshwari Sridhara,Peter A. Fasching,Leen Slaets,Shenghui Tang,Bernd Gerber,Charles E. Geyer,Richard Pazdur,Nina Ditsch,Priya Rastogi,Wolfgang Eiermann,Gunter von Minckwitz +36 more
TL;DR: In this paper, the authors compared the three most commonly used definitions of pathological complete response (ypT0 ypN0, ypT0/is ypNs0, and ypTsN0/IsYPN0) for their association with EFS and overall survival in clinical trials of neoadjuvant treatment of breast cancer.
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Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma.
Vicki L. Goodman,Edwin P. Rock,Ramzi Dagher,Roshni Ramchandani,Sophia Abraham,Jogarao V. S. Gobburu,Brian Booth,S. Leigh Verbois,David E. Morse,Cheng Yi Liang,Nallaperumal Chidambaram,Janet X. Jiang,Shenghui Tang,Kooros Mahjoob,Robert Justice,Richard Pazdur +15 more
TL;DR: In patients with imatinib refractory or intolerant GIST, time-to-tumor progression of sunitinib-treated patients was superior to that of placebo- treated patients, and in patients with metastatic renal cell carcinoma, partial responses were observed.
Journal ArticleDOI
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
Geoffrey Kim,Gwynn Ison,Amy E. McKee,Hui Zhang,Shenghui Tang,Thomas Gwise,Rajeshwari Sridhara,Eunice Y. Lee,Abraham Tzou,Reena Philip,Haw-Jyh Chiu,Tiffany K. Ricks,Todd R. Palmby,Anne Marie Russell,Gaetan Ladouceur,Elimika Pfuma,Hongshan Li,Liang Zhao,Qi Liu,Rajesh Venugopal,Amna Ibrahim,Richard Pazdur +21 more
TL;DR: The most common adverse reactions in patients treated with olaparib were anemia, nausea, fatigue, vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngritis/upper respiratory infection, cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash, and abdominal pain/discomfort.
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Sorafenib for the Treatment of Advanced Renal Cell Carcinoma
Robert C. Kane,Ann T. Farrell,Haleh Saber,Shenghui Tang,Gene M. Williams,Josephine M. Jee,Chengyi Liang,Brian Booth,Nallaperumal Chidambaram,David L. Morse,Rajeshwari Sridhara,Patricia Garvey,Robert Justice,Richard Pazdur +13 more
TL;DR: Sorafenib received FDA regular approval for the treatment of advanced RCC based on the persuasive magnitude of improvement in PFS with acceptable safety, and the recommended dose is 400 mg twice daily taken either 1 h before or 2 h after meals.
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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer
Julia A. Beaver,Laleh Amiri-Kordestani,Rosane Charlab,Wei Chen,Todd R. Palmby,Amy Tilley,Jeanne Fourie Zirkelbach,Jingyu Yu,Qi Liu,Liang Zhao,Joyce Z. Crich,Xiao Hong Chen,Minerva Hughes,Erik Bloomquist,Shenghui Tang,Rajeshwari Sridhara,Paul G. Kluetz,Geoffrey Kim,Amna Ibrahim,Richard Pazdur,Patricia Cortazar +20 more
TL;DR: The FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMa-2 are summarized.