Roche's Alecensa gets fast-track approval in China

The China National Drug Administration (CNDA) has expedited the approval process for Roche's (SIX: ROG) cancer therapy Alecensa (alectinib), an innovative therapy for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The company said in a statement on Monday that the CNDA had granted Alecensa marketing authorization following a priority review, with the approval coming less than a year after Alecensa was approved by the US Food and Drug Administration and the European Medicines Agency.

"Today’s approval marks a new era for ALK-positive lung cancer patients in China, who now have a treatment option that offers a meaningful, sustained benefit compared with the previous standard of care," said Sandra Horning, Roche’s chief medical officer and head of global product development.