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 or the prescribing information.

Diseases for which it is used

• Anaplastic large cell lymphoma
• ALK+ non-small cell lung cancer

Patient drug information

• Alectinib (Alecensa) package insert

History of changes in FDA indication

• 2015-12-11: 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. (Based on NP28761 and NP28673)
• 2017-11-06: 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. (Converted to regular approval; prior crizotinib exposure requirement removed; based on ALEX)
• 2024-04-18: Approved for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. (Based on ALINA)

History of changes in EMA indication

• 2017-02-16: Initial marketing authorization as Alecensa as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
• 2017-12-18: Extension of Indication for Alecensa (alectinib) to first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). (Prior treatment criteria removed)

History of changes in Health Canada indication

• 2016-09-28: Initial notice of compliance with conditions as a monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
  • 2018-09-26: Conditions were met for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
• 2018-06-11: New indication for the first-line treatment of patients with anaplastic lymphoma kinase-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer.

History of changes in PMDA indication

• 2014-07-04: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive non-small cell lung cancer.
• 2020-02-21: New indication and a new dosage for the treatment of relapsed or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

Also known as

• Code names: AF-802, CH-5424802, RG-7853, RO-5424802, UNII-LIJ4CT1Z3Y
• Brand names: Alecensa, Alecensaro, Alecinix, Alecnib, Alnib