Alectinib (Alecensa)

General information

Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK). Alectinib and its metabolite M4 inhibit ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, which results in decreased growth of tumor cells which have ALK fusions, amplifications, or activating mutations.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• ALK+ non-small cell lung cancer

Patient drug information

• Alectinib (Alecensa) package insert

History of changes in FDA indication

• 12/11/2015: Granted accelerated FDA approval "for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib."
• 11/6/2017: Granted regular FDA approval "for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test."

Also known as

• Code names: AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y
• Brand name: Alecensa