Alectinib (INN[8]), sold under the brand name Alecensa, is an anticancer medication that is used to treat non-small-cell lung cancer (NSCLC).

[7] In the United States, it is indicated for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

[6] In April 2024, the US Food and Drug Administration (FDA) expanded the indication of alectinib to include adjuvant treatment following tumor resection in people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

[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] Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in participants with ALK-positive NSCLC who had complete tumor resection.

[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] In April 2024, the FDA approved alectinib as an adjuvant treatment for people with ALK-positive early-stage lung cancer.

[22] Alectinib was approved in Japan in July 2014,[23] for the treatment of ALK fusion-gene positive, unresectable, advanced or recurrent non-small-cell lung cancer (NSCLC).

[10] Alectinib was granted an accelerated approval by the US Food and Drug Administration (FDA) in December 2015, to treat people with advanced ALK-positive NSCLC whose disease worsened after, or who could not tolerate, treatment with crizotinib (Xalkori).