FDA approves alectinib (Alecensa) as 1st line treatment

As of November 6, 2017

FDA approves alectinib (Alecensa) as 1st line treatment based on Phase 3 results.

The estimated median Progression Free Survival (PFS) for patients taking alectinib was 25.7 months, compared with 10.4 months for those taking crizotinib.

The Objective Response Rate (ORR) was 79% and 72%  in the alectinib and crizotinib arms, respectively.

Among the 120 responders in the alectinib arm and the 109 responders in the crizotinib arm, the proportion of patients with response duration of ≥12 months was 64% and 36%, respectively.

The Central Nervous System (CNS) ORR was 81% among patients taking alectinib and 50% among patients taking crizotinib.

Among patients with measurable CNS lesions and a CNS response, the proportion of patients with a CNS response duration of ≥12 months was 59% in the alectinib arm and 36% in the crizotinib arm.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584082.htm

This entry was posted in alectinib - Alecensa from Chugai - Roche - GenenTech, Brain metastases, Lung cancer, Potential Treatments, Regulatory applications & approvals. Bookmark the permalink.

Leave a Reply