China Grants Alecensa Rapid Approval
Roche’s Alecensa (alectinib) received rapid approval in China for treating anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
The approval came only eight and nine months after the EMA and FDA approvals, respectively. Alecensa is now approved in over 57 countries as a first-line treatment, including the U.S., Europe and Japan.
The approval “represents a significant regulatory shift, with the approval received under unprecedented timelines,” said Sandra Horning, Roche’s chief medical officer and head of global product development.