Analysis of FDA's Review for NDA208542-Rociletinib
- VernacularTitle:NDA208542-Rociletinib的FDA审评案例分析
- Author:
Na AN
1
;
Jianyuan TANG
Author Information
- Keywords: Non-small cell lung cancer; U.S.Food and Drug Administration; review and approval; case analysis; new drug application; precision medicine
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2017;19(7):1083-1088
- CountryChina
- Language:Chinese
- Abstract: 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.
