The Skeptical Oncologist
By BISHAL GYAWALI, MD Why conduct post approval studies at all? Atezolizumab previously received accelerated approval in second-line metastatic or advanced urothelial cancer based on response rates from a single arm trial. The results of post approval confirmatory phase 3 are now published and demonstrate that atezolizumab did not improve survival versus chemotherapy (11.1 v 10.6 months, HR 0.87, p = 0.41). The concept of accelerated approval is to grant early and conditional approval and access to drugs in diseases of unmet need, and that the decision to fully approve or revoke be made based on results of confirmatory phase 3 trials. That means, if the confirmatory larger phase 3 trial shows that the assumed benefit with the drug didn’t exist, the approval be revoked. Naturally, the FDA has decided to revoke the approval. No, I am joking. The post approval studies don’t seem to matter at all. You can improve response rate in a single arm trial, gain an expedited approval and your approval will always remain. Previously, we also saw that a drug that was given accelerated approval based on response rates in a phase 2 received full approval after it failed to improve survival in a subsequent confirmatory phase 3. Why bother conducting confirmatory studies at all? (Im)precision in precision oncology It goes without question that precision medicine requires precise measurement and validation of biomarkers. So it was very pleas...
Pei-Li Zhu, Xiu-Qiong Fu, Jun-Kui Li, Anfernee Kai-Wing Tse, Hui Guo, Cheng-Le Yin, Ji-Yao Chou, Ya-Ping Wang, Yu-Xi Liu, Ying-Jie Chen, Muhammad Jahangir Hossen, Yi Zhang, Si-Yuan Pan, Zong-Jie Zhao, Zhi-Ling Yu
Kelvin M. Jones, Balasubramanyam Karanam, Jacqueline Jones-Triche, Maninder Sandey, Henry J. Henderson, Rajeev S. Samant, Samuel Temesgen, Clayton Yates, Deepa Bedi
Marie-France Penet, Balaji Krishnamachary, Flonn é B. Wildes, Yelena Mironchik, Chien-Fu Hung, TC Wu, Zaver M. Bhujwalla
Dr. Susan Slovin discusses how the evolution of therapeutic treatment is occurring in advanced stage prostate cancer Author: vhsimons Added: 12/17/2018
The concept of Precision Therapy in Prostate Cancer treatment will need to rely more heavily on genetic testing Author: vhsimons Added: 12/17/2018
Jiyan Su, Dan Li, Qianjun Chen, Muxia Li, Lu Su, Ting Luo, Danling Liang, Guoxiao Lai, Ou Shuai, Chunwei Jiao, Qingping Wu, Yizhen Xie, Xinxin Zhou
Juan P. Mu ñoz, Diego Carrillo-Beltrán, Víctor Aedo-Aguilera, Gloria M. Calaf, Oscar León, Edio Maldonado, Julio C. Tapia, Enrique Boccardo, Michelle A. Ozbun, Francisco Aguayo
Org. Biomol. Chem., 2018, Accepted Manuscript DOI: 10.1039/C8OB02668H, PaperYong qiang Zhu, Meng Lei, Huayun Feng, Enhe Bai, Hui Zhou, Jia Wang, Yan ru Qin, Hao yang Zhang, Xueyuan Wang, Zhaogang Liu, Ou Hai, Jia Liu A series of novel dipeptidyl boronic acid compounds were designed, synthesized and biologically investigated the inhibition of β5 subunit of 20S proteasome and several compounds showed high activities with the... The content of this RSS Feed (c) The Royal Society of Chemistry
Research suggests body ’s response to infection may be responsible for onset of CFSAn overactive immune response appears to be a trigger for persistent fatigue, say researchers in a study that could shed light on the causes of chronic fatigue syndrome.Chronic fatigue syndrome (CFS) is a debilitating long-term condition in which individuals experience exhaustion that is not helped by rest, as well as pain, mental fogginess and trouble with memory and sleep. It is also known as myalgic encephalomyelitis (ME).Continue reading...
Jun Wang, Zhen-Yu He, Yong Dong, Jia-Yuan Sun, Wen-Wen Zhang, San-Gang Wu
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