Simultaneous development of zanubrutinib in the USA and China

Nature Reviews Clinical Oncology, Published online: 10 July 2020; doi:10.1038/s41571-020-0414-yZanubrutinib was recently granted expedited approval by the USA and Chinese drug regulatory authorities for the treatment of mantle cell lymphoma, thus becoming the first investigational new drug discovered in China to achieve simultaneous development in both countries. Here, we provide an overview of the regulatory processes and considerations of the two health authorities and discuss the pathways of concurrent review and approval.

Source: Nature Reviews Clinical Oncology - July 9, 2020 Category: Cancer & Oncology Authors: Guanqiao Li Xiaozhen Liu Xiaoyuan Chen Source Type: research