FDA Grants Accelerated Approval to Roche’s Lung Cancer DrugBy
The US Food and Drug Administration has granted accelerated approval to Roche’s Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In addition, Alecensa is being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC.
Alecensa is an investigational oral medicine created at Chugai Pharmaceutical, a member of the Roche Group, and is being developed for people with NSCLC whose tumors are identified as ALK+. ALK+ NSCLC is often found in younger people who have a light or non-smoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma.
The global Phase III studies of Alecensa include a companion test developed by Roche. Alecensa is marketed in Japan by Chugai Pharmaceutical.