publication date: Nov. 10, 2017

Drugs and Targets Alecensa gets FDA approval for ALK-positive metastatic NSCLC

FDA has granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, as detected by an FDA-approved test.

The drug is sponsored by Genentech Inc., a unit of Hoffmann-La Roche Inc.

FDA granted breakthrough therapy designation to alectinib for this indication in September 2016.

In December 2015, alectinib received an accelerated approval for treatment of patients with ALK-positive metastatic NSCLC whose disease progressed on or who were intolerant of crizotinib based on an independent review committee-assessed overall response rate of 38% and 44% among 87 and 138 patients, respectively, in two single arm trials.

This current approval is based on data from ALEX (NCT02075840), a randomized, multi-center, open-label, active-controlled trial conducted in 303 patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease. All patients were required to have evidence of ALK-rearrangement identified by the VENTANA ALK (D5F3) CDx Assay performed through central laboratory testing. Patients were randomized 1:1 to receive alectinib 600 mg orally twice daily (n=152) or crizotinib 250 mg orally twice daily (n=151).

ALEX demonstrated an improvement in progression-free survival as assessed by blinded IRC, with a hazard ratio of 0.53 (95% CI: 0.38, 0.73; … Continue reading Alecensa gets FDA approval for ALK-positive metastatic NSCLC

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