ensartinib
Drug Details
- Generic Name
- ensartinib
- Brand Names
- ENSACOVE
- Application Number
- NDA218171
- Sponsor
- Xcovery Holdings, Inc.
- NDC Codes
- 2
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- ENSARTINIB HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )