Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 150 mg) |
| Drug Class | Kinase 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.
Latest News
Summary
- This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-27]
- Progression-Free Survival (PFS): Alectinib demonstrated significant improvement in PFS compared to crizotinib and chemotherapy, with lorlatinib showing the best PFS among next-generation anaplastic lymphoma kinase (ALK) inhibitors, especially effective in patients with brain metastases. Brigatinib also showed superior PFS relative to crizotinib and ceritinib.
- Overall Survival (OS): Alectinib significantly prolonged OS compared to crizotinib and chemotherapy. Evidence for OS improvement with lorlatinib and brigatinib exists but is less robust than for alectinib.
- Objective Response Rate (ORR): Alectinib and lorlatinib generally displayed higher ORRs than crizotinib and chemotherapy, with alectinib (600 mg BID) demonstrating the highest ORR among the ALK inhibitors.
- Intracranial Time to Progression (IC TTP): Both lorlatinib and alectinib effectively prevented central nervous system (CNS) progression compared to other ALK inhibitors, showing significant intracranial efficacy.
- Adverse Events (AEs): Alectinib demonstrated a favorable safety profile with fewer grade ≥3 AEs compared to other ALK inhibitors, while lorlatinib had a higher incidence of severe AEs, including hypertriglyceridemia and hypercholesterolemia. Ceritinib showed the highest rate of severe AEs among the ALK inhibitors.
- Discontinuation Due to AEs: Alectinib had the lowest discontinuation rates due to AEs, whereas lorlatinib and brigatinib had higher rates of discontinuation compared to other ALK inhibitors.
- Comparison of Safety: Lorlatinib presented a higher incidence of severe AEs relative to alectinib and brigatinib, while ceritinib had the highest rate of severe AEs and dose reductions due to AEs among the ALK inhibitors.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Alecensa (alectinib) Prescribing Information. | 2024 | Genentech, Inc., South San Francisco, CA |