Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion

Rozlytrek (entrectinib), a kinase inhibitor, has received approval to treat adults and adolescents with cancer that carries the genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and has progressed following other treatment, the U.S. Food and Drug Administration announced last week.

The drug was also approved to treat adults with metastatic non-small cell lung cancer and ROS1-positive tumors. The recommended dose for adults with either indication -- NTRK gene fusion-positive tumors or ROS1-positive non-small cell lung cancer -- is 600 mg orally once daily. Dosage in adolescent patients aged 12 years and older is based on body surface area.

The approval of Rozlytrek to treat NTRK gene fusion-positive tumors was based on data from four clinical trials of 54 adult patients. Fifty-seven percent of patients with NTRK gene fusion-positive tumors who received Rozlytrek had substantial tumor shrinkage, and tumors completely disappeared in 7.4 percent of treated patients. Tumor shrinkage persisted for nine months or longer in 61 percent of patients with a response. The most common cancers among these patients were lung, salivary gland, breast, thyroid, and colon/rectum. The drug's approval for metastatic non-small cell lung cancer with ROS1-positive tumors was based on clinical data from 51 patients. The overall response rate was 78 percent, and complete disappearance of the cancer occurred in 5.9 percent of patients. Tumor shrinkage persisted for at least one year in 55 percent of responsive patients.

The most commonly reported side effects of Rozlytrek include fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, weight gain, cough, vomiting, fever, arthralgia, and vision disorders. Serious side effects of Rozlytrek include heart failure, central nervous system effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision disorders.

This approval is the third by the FDA for a cancer drug that treats a specific biomarker across different tumor types. Approval was granted to Genentech.

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