Alectinib

(Alecensa®)

Alecensa®

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 150 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test.
  • Indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

Summary
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  • Alectinib (Alecensa) is indicated for the treatment of adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), and also in cases with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
  • The information was derived from 43 systematic reviews and meta-analyses, focusing on various aspects like overall survival, progression-free survival, objective response rates, and safety profiles including adverse events.
  • In terms of efficacy and effectiveness, alectinib consistently shows superior progression-free survival compared to crizotinib and chemotherapy. It is highly effective for Asian patients and those with central nervous system metastases.
  • Alectinib stands out for significantly prolonging overall survival when compared to other ALK inhibitors such as ceritinib or brigatinib. Its objective response rate indicates that a significant proportion of patients experience tumor shrinkage.
  • Safety profile analysis reveals that alectinib generally exhibits fewer serious adverse events compared to other ALK inhibitors like ceritinib or lorlatinib. This makes it more tolerable due to its lower incidence rates of severe adverse events.
  • Subgroup analyses demonstrate alectinib's superior efficacy across diverse patient populations including those previously treated with crizotinib or chemotherapy, indicating its role as a robust treatment option in various therapeutic lines.
  • Regional Efficacy Variations show that alectinib appears notably efficacious in Asian populations, offering significant PFS advantages, highlighting the importance of considering genetic and regional differences in drug response.
  • Alectinib emerges as a highly effective and relatively safe treatment option, especially for CNS metastases. Its safety profile, coupled with high efficacy in improving PFS and OS, positions it as a preferable first-line therapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Alecensa (alectinib) Prescribing Information.2024Genentech USA Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Identifying optimal ALK inhibitors in first- and second-line treatment of patients with advanced ALK-positive non-small-cell lung cancer: a systematic review and network meta-analysis.2024BMC Cancer
Comparing efficacy and safety of upfront treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: a network meta-analysis.2023Exploration of targeted anti-tumor therapy
Comparative efficacy of ALK inhibitors for treatment-naïve ALK-positive advanced non-small cell lung cancer with central nervous system metastasis: a network meta-analysis.2023International Journal of Molecular Sciences
Efficacy and safety of first-line treatments for patients with advanced anaplastic lymphoma kinase mutated, non-small cell cancer: a systematic review and network meta-analysis.2023Cancer
Alectinib for treating patients with metastatic ALK-positive NSCLC: systematic review and network metanalysis.2023Lung Cancer Management
Efficacy and safety of anaplastic lymphoma kinase inhibitors for non–small cell lung cancer: a systematic review and network meta-analysis.2023Thoracic Cancer
Comparative safety of anaplastic lymphoma kinase tyrosine kinase inhibitors in advanced anaplastic lymphoma kinase-mutated non-small cell lung cancer: systematic review and network meta-analysis.2023Lung Cancer
A Bayesian network meta-analysis of ALK inhibitor treatments in patients with ALK-positive non-small cell lung cancer.2023Cancer Medicine
Safety and efficacy of alectinib versus crizotinib in ALK-positive non-small cell lung cancer: an update meta-analysis.2023Pakistan Journal of Pharmaceutical Sciences
First-line treatments for patients with advanced ALK gene rearrangements in NSCLC: a systematic review and network meta-analysis.2022Journal of International Medical Research
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)‐rearranged non‐small cell lung cancer.2022Cochrane Database of Systematic Reviews
A systematic review of companion diagnostic tests by immunohistochemistry for the screening of alectinib-treated patients in ALK-positive non-small cell lung cancer. 2022Diagnostics
Toxicity profile of anaplastic lymphoma kinase tyrosine kinase inhibitors for patients with non small cell lung cancer: a systematic review and meta analysis. 2022Investigational New Drugs
ALK inhibitors in ALK-rearranged non-small cell lung cancer with and without brain metastases: systematic review and network meta-analysis.2022BMJ Open
Indirect comparisons of brigatinib and alectinib for front-line ALK-positive non-small-cell lung cancer.2022Future Oncology
Comparison of efficacy and safety of brigatinib in first-line treatments for patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer: a systematic review and indirect treatment comparison.2022Journal of Clinical Medicine
Front-line treatment for advanced non-small-cell lung cancer and ALK fusion: a network meta-analysis.2022Therapeutic Advances in Medical Oncology
Crizotinib versus alectinib for the treatment of ALK-positive non-small cell lung cancer: a systematic review and meta-analysis.2022Chemotherapy
Overall survival indirect treatment comparison between brigatinib and alectinib for the treatment of front-line anaplastic lymphoma kinase-positive non-small cell lung cancer using data from ALEX and final results from ALTA-1L.2022Current Medical Research and Opinion
First-line anaplastic lymphoma kinase (ALK) inhibitors for ALK-positive lung cancer in Asian populations: systematic review and network meta-analysis.2021Journal of Clinical Medicine
Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: a meta-analysis of clinical trials. 2021BMC Cancer
Crizotinib versus alectinib for the treatment of ALK-positive non-small cell lung cancer: a systematic review and meta-analysis. 2021Chemotherapy
Systematic review and network meta-analysis of anaplastic lymphoma kinase (ALK) inhibitors for treatment-naïve ALK-positive lung cancer. 2021Cancers
Comparison of lorlatinib, alectinib and brigatinib in ALK inhibitor–naive/untreated ALK-positive advanced non-small-cell lung cancer: a systematic review and network meta-analysis. 2021Journal of Chemotherapy
Comparative efficacy and safety of lorlatinib and alectinib for ALK-rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: a systematic review and network meta-analysis. 2021Cancers
Comparison of clinical efficacy of alectinib versus crizotinib in ALK-positive non-small cell lung cancer: a meta-analysis. 2021Frontiers in Oncology
ALK inhibitor-induced bradycardia: a systematic-review and meta-analysis.2021Lung Cancer
A Bayesian network meta-analysis regarding the comparative efficacy of therapeutics for ALK-positive, brain metastatic non-small cell lung cancer.2021Pharmacological research
Comparison of clinical efficacy of alectinib versus crizotinib in ALK-positive non-small cell lung cancer: a meta-analysis.2021Frontiers in oncology
Efficacy and safety of first-line treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: a Bayesian network meta-analysis.2021Frontiers in oncology
Comparative efficacy of systemic agents for brain metastases from non-small-cell lung cancer with an EGFR mutation/ALK rearrangement: a systematic review and network meta-analysis.2021Frontiers in oncology
Effect of alectinib versus crizotinib on progression-free survival, central nervous system efficacy and adverse events in ALK-positive non-small cell lung cancer: a systematic review and meta-analysis.2020Annals of Palliative Medicine
Brigatinib and alectinib for ALK rearrangement-positive advanced non-small cell lung cancer with or without central nervous system metastasis: a systematic review and network meta-analysis.2020Cancers
ALK inhibitors for non-small cell lung cancer: a systematic review and network meta-analysis.2020PLoS One
Comparative efficacy of targeted therapies in patients with non-small cell lung cancer: a network meta-analysis of clinical trials.2020Journal of Clinical Medicine
Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer.2020Lung cancer
Cost effectiveness of ceritinib and alectinib versus crizotinib in first-line anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer.2020Clinical Drug Investigation
Efficacy of crizotinib, ceritinib, and alectinib in ALK-positive non-small cell lung cancer treatment: a meta-analysis of clinical trials. 2020Cancers
Effect of alectinib versus crizotinib on progression-free survival, central nervous system efficacy and adverse events in ALK-positive non-small cell lung cancer: a systematic review and meta-analysis.2020Annals of palliative medicine
Meta-analysis of overall incidence and risk of ALK inhibitors-induced liver toxicities in advanced non-small-cell lung cancer.2019Medicine (Baltimore)
ALK inhibitors in the treatment of ALK positive NSCLC.2019Frontiers in Oncology
Safety issues with the ALK inhibitors in the treatment of NSCLC: a systematic review.2019Critical Reviews in Oncology/Hematology
The safety and serious adverse events of approved ALK inhibitors in malignancies: a meta-analysis.2019Cancer Management and Research
The incidence of ALK inhibitor-related pneumonitis in advanced non-small-cell lung cancer patients: a systematic review and meta-analysis.2019Lung cancer
Anaplastic lymphoma kinase inhibitors in non-small cell lung cancer patients with brain metastases: a meta-analysis.2019Journal of Thoracic Disease

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