What is the generic name?

ENTRECTINIB

What is the Trade Name for ENTRECTINIB?

Rozlytrek

What are the Indications for ENTRECTINIB?

• 1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1 -positive. ( 1.1 ) Adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer ROZLYTREK is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1 -positive. 1.2 NTRK Gene Fusion-Positive Solid Tumors ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

References: https://open.fda.gov/