Fast Approval for Roche Drug Alecensa in China

Lung cancer drug is one of first on China’s list of 48 western drugs targeted for fast approvals.

As part of its strategy to get more advanced treatments on the Chinese market and in the hands of expectant patients, the Chinese government is revamping its drug approval strategy. Recently China’s Food and Drug Administration (China FDA) introduced a new priority review pathway and the Chinese Center for Drug Evaluation (CDE) issued a list of 48 drugs approved in either the US, EU or Japan that are needed in the clinical setting and that are targeted for fast approvals. Makers of the drugs on the list can immediately apply for marketing approval and be eligible for priority review with existing data if they can provide evidence that the drugs work equally well.

Roche has reported approval by the China National Drug Administration of one of its drugs on that list – Alecensa (alectinib), a frontline therapy for advanced cases of ALK-positive non-small cell lung cancer. This approval in China comes less than a year after Alecensa was approved in the US and EU for frontline use following evaluation of new data demonstrating its efficacy in treating patients compared to a standard of care.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.