Alectinib Hydrochloride
Drug Details
- Generic Name
- Alectinib Hydrochloride
- Brand Names
- N/A
- Application Number
- Sponsor
- ScinoPharm Taiwan Ltd.
- NDC Codes
- 6
- Dosage Forms
- POWDER, CAPSULE
- Routes
- N/A
- Active Ingredients
- ALECTINIB HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in 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. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in 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 [see Dosage & Administration (2.1) ]. 1.2 Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .