Roche: alecesa approved in China
(CercleFinance.com) - Roche announces that the National Medicines administration of China (CNDA) has granted marketing authorisation for alecensa (alectinib) as monotherapy for patients with advanced alk positive non-small cell lung cancer (NSCLC).
This approval follows a priority review of alecensa in China and was obtained only eight and nine months after approvals from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), respectively.
Chinese approval is based on data from ALEX, the global central pivot study of phase III, which shows that alecensa significantly reduces the risk of disease or death progression by over half compared to crizotinib.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
This approval follows a priority review of alecensa in China and was obtained only eight and nine months after approvals from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), respectively.
Chinese approval is based on data from ALEX, the global central pivot study of phase III, which shows that alecensa significantly reduces the risk of disease or death progression by over half compared to crizotinib.
Copyright (c) 2018 CercleFinance.com. All rights reserved.