Analysis of FDA's Review for NDA208542-Rociletinib / 世界科学技术-中医药现代化

Lung cancer is the highest mortality rate of malignancies in the world.Among them,non-small cell lung cancer (NSCLC) accounts for 85％.Epidermal growth factor receptor (EGFR) gene is one of the most common driving genes in NSCLC.The EGFR tyrosine kinase inhibitors (EGFR-TKIs) bring a breakthrough in the treatment for patients with EGFR gene-sensitive mutations.However,the drug resistance problem of EGFR-TKIs has been increasingly highlighted.So a drug for the patients accompanied by EGFR T790M positive mutation and along with progression in or after treatment with EGFR-TKI NSCLC is clinically urgent needed.Rociletinib is designed to address this unmet clinical need.While considering the non-superior effectiveness to the similar drugs in the market and the high risk of safety (hyperglycemia,QT prolongation and sudden death) of Rociletinib,the dosage was not accepted by the Food and Drug Administration (FDA).And Rociletinib did not make it to the market eventually.This paper discussed lessons learned from this case under review perspective for reference and inspiration.

Bipolar disorder: a review of current U.S. Food and Drug Administration approved pharmacotherapy.

Bipolar disorder (BD) is a chronic disorder which usually has its onset in early adulthood. At one end of the spectrum is depression and at other is mania. Like many psychiatric illnesses, it is not treatable but its symptoms are completely manageable with medications. Commonly used drugs are mood stabilizers and atypical antipsychotics along with adjunctive medications such as anxiolytics and antidepressants. In general, a combination of these drugs is used for treatment. These drugs have significant adverse effects which add to the burden of the disease. Presently, there are 11 US Food and Drug Administration - approved drugs for management of acute mania, 3 for bipolar depression and 7 for bipolar maintenance. This review article details the use of these drugs in BD.