History
The approvals were based mainly on two trials: In a Japanese Phase I–II trial, after approximately 2 years, 19.6% of patients had achieved a complete response, and the 2-year progression-free survival rate was 76%.[10] In February 2016 the J-ALEX phase III study comparing alectinib with crizotinib was terminated early because an interim analysis showed that progression-free survival was longer with alectinib.[15]
In November 2017, the FDA approved alectinib for the first-line treatment of people with ALK-positive metastatic non-small cell lung cancer.[16] This based on the phase 3 ALEX trial comparing it with crizotinib.[16]
Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in participants with ALK-positive NSCLC who had complete tumor resection.[11] Eligible participants were required to have resectable stage IB (tumors ≥ 4 cm) to IIIA NSCLC (by AJCC 7th edition) with ALK rearrangements identified by a locally performed FDA-approved ALK test or by a centrally performed VENTANA ALK (D5F3) CDx assay.[11] A total of 257 participants were randomized (1:1) to receive alectinib 600 mg orally twice daily or platinum-based chemotherapy following tumor resection.[11] The application was granted priority review and orphan drug designations.[11]
In April 2024, the FDA approved alectinib as an adjuvant treatment for people with ALK-positive early-stage lung cancer.[17] This was based on the Phase III ALINA study [NCT03456076].[18]
In April 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for the use of alectinib for adjuvant treatment of resected non‑small cell lung cancer (NSCLC).[7][19] In June 2024, the EU approved alectinib as an adjuvant treatment for people in the EU with ALK-positive early-stage lung cancer.[20] This was based on the Phase III ALINA study [NCT03456076].[21]
In October 2024, the UK`s NICE recommended alectinib as an adjuvant treatment for adults for the treatment of stage 1B to 3A ALK-positive non-small-cell lung cancer.[22]
