taletrectinib

FDA Drug Profile — IBTROZI

Drug Details

Generic Name
taletrectinib
Brand Names
IBTROZI
Application Number
NDA219713
Sponsor
Nuvation Bio Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
TALETRECTINIB ADIPATE

Indications and Usage

1 INDICATIONS AND USAGE IBTROZI ™ (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration ( 2.1 )] . IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). ( 1 )