Generic Name: entrectinib

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Roche/Genentech

Approval Status: Approved

Generic Version Available: No

Experimental Code: RXDX-101

Drug Indication

Rozlytrek is approved for the treatment of solid tumors anywhere in the body that have NTRK gene fusions and for ROS1-positive non-small-cell lung cancer.

General Info

Rozlytrek targets cancers with fusions in NTRK (neurotrophic tyrosine receptor kinase) genes, which produce (tropomyosin receptor kinase) proteins. When a TRK-producing gene fuses with another gene, it acts as an ignition switch to accelerate tumor growth. The drug also targets ROS1 and ALK gene alterations. NTRK fusions occur in about 1% of all cancers but are more common in some rare cancers; ROS1 gene fusions are found in about 2% of non-small-cell lung cancer.

Phase I and II studies (STARTRK-1, STARTRK-2 and ALKA-372-001) of adults with 10 types of advanced solid tumors with NTRK fusions found that entrectinib slowed disease progression and was active against cancer that had spread to the brain. The STARTRK-NG trial found that entrectinib was highly effective in children, mostly with brain cancer. Entrectinib was approved on August 15, 2019.


Dosing Info: Entrectinib is taken as a once-daily pill.

Side Effects

The most common side effects include fatigue, constipation, diarrhea, nausea, swelling, dizziness, vision problems and an altered sense of taste (dysgeusia) or touch (dysesthesia). Serious adverse events may include congestive heart failure and heart rhythm abnormalities, central nervous system side effects, liver toxicity, vision disorders and bone fractures. Rozlytrek may cause birth defects if used during pregnancy.

For More Info:

Patient Assistance Program Info:

Last Reviewed: August 15, 2019