Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals. Clinical trial endpoints for the approval of cancer drugs and biologics: guidance for industry. The United States Food and Drug Administration. Technical guidance for procedure standard of cancer drug clinical trials imaging endpoints (draft). Accessed June 30, 2022.Ĭentre for Drug Evaluation NMPA. Technical guidance for cancer drug clinical trials endpoints. ![]() Outcomes and endpoints in cancer trials: bridging the divide. With the increase of cancer drug approvals based on single-arm trials or immature survival data in recent years, these findings highlight the need to routinely monitor the clinical benefits of new cancer therapies in China. In this study, almost half of cancer drug indications approved in China had demonstrated OS gain. Fewer than one-third of cancer drug indications approved in China only had documented evidence of OS benefits (9 of 30 ), whereas more than one-half of the cancer drug indications also available in the US or Europe had OS benefits (59 of 111 ). After a median follow-up of 1.9 (range, 1.0-11.1) years from approval, OS data for 13 indications (9.2%) were either not reported or were still not mature. For 68 indications (48.2%) that had documented evidence of OS benefit, the median magnitude of OS improvement was 4.1 (range, 1.0-35.0) months. By June 30, 2021, 34 drug indications (24.1%) had a documented lack of OS gain. Of all indications, 26 (18.4%) were evaluated in single-arm or dose-optimization trials, most of which were authorized after 2017. Secondary outcome measures were the magnitude of OS benefit and other primary efficacy measures in pivotal trials.īetween 20, 78 cancer drugs corresponding to 141 indications were authorized in China, including 20 drugs (25.6%) (for 30 indications) approved in China only. The primary outcome measure was a documented statistically significant positive OS difference between a new cancer therapy and a comparator treatment. The literature published up to June 30, 2021, was reviewed to collect results on end points used in pivotal trials supporting cancer drug approvals. Lingyan Li, Rui Li, Jun Yu, A Mass Spring Based 3D Virtual Hair Dynamic System for Straight and Curly Hair, Chinese Control Conference, 2016, pp. This mixed-methods study comprising a systematic review and cross-sectional analysis identified antineoplastic agents approved in China between January 1, 2005, and December 31, 2020, using publicly available data and regulatory review documents issued by the National Medical Products Administration. Yu Liu, Baocai Yin, Jun Yu, Zengfu Wang, Cross-Level: A Practical Strategy for Convolutional Neural Networks Based Image Classification, Chinese Conference on Computer Vision, 2015, pp. To characterize the clinical benefits of cancer drugs approved in China, as defined by the availability and magnitude of statistically significant overall survival (OS) results. However, evidence on the clinical benefits of new cancer therapies authorized in China is not available. Recent regulatory reforms in China have focused on improving the availability of new cancer drugs. He currently lives in the Los Angeles area.Of approximately 9 million patients with cancer in China in 2020, more than half were diagnosed with late-stage cancers. He is currently working on his debut EP, and notes some of his musical influences are Mac Miller, Andre 3000, Lauryn Hill, and J. ![]() In addition to working in front of the camera, Yu has a passion for music and is a rapper in his down time. While working on his degree Yu secured his first real acting audition for "Mulan" and landed the role, he has been working ever since. Upon graduating high school, he was accepted into USC's BFA program for their School of Dramatic Arts, whose alumni include Forrest Whittaker, America Ferrera, Will Ferrell and Ron Howard. He was instantly drawn to the art of bringing characters to life and began taking summer courses at the prestigious University of Southern California and University of California - Berkeley. Born in Oakland, California and raised across the Bay Area, Yu discovered his love of acting after accidentally enrolling in a theatre course his sophomore year of high school. On the television front, Yu has recurred as Pete on ABC's hit comedy series "Fresh Off the Boat," alongside Randall Park and Constance Wu. "Mulan" is set to premiere on March 27, 2020. Yu is a scene-stealer as Cricket, Mulan's comrade and confidant as she enters training military training and war. Set in Imperial China, the film follows Mulan (Liu) who disguises herself as a man in order to serve in the military to defend the country from the Huns. In 2020, actor on the rise, Jun Yu, is set to make his feature film debut in Walt Disney Pictures' highly anticipated, live action adaptation of "Mulan" opposite Yifei Liu, Jet Li, Tzi Ma and Rosalind Chao.
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