Independent reference. Not affiliated with, endorsed by, or speaking for the U.S. Food and Drug Administration.
FDA Medication Tracker

← All approvals · Cancer · 2024

Ensacove (ensartinib)

The FDA approved Ensacove (ensartinib) on December 18, 2024 to treat non-small cell lung cancer.
Brand name
Ensacove
Generic name
ensartinib
FDA approval date
December 18, 2024
Approved use (FDA wording)
To treat non-small cell lung cancer
Company
Xcovery
Application
NDA218171
Dosage form / route
CAPSULE · ORAL
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

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 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.