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Roche’s Rozlytrek Wins EU Approval

For the treatment of solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and ROS1-positive, advanced non-small cell lung cancer.

By: Contract Pharma

Contract Pharma Staff

Roche received approval from the European Commission for Rozlytrek (entrectinib) for the treatment of solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgery is likely to result in severe morbidity.

The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

The approval is based on results demonstrating that Rozlytrek has durable responses across several NTRK gene fusion-positive solid tumors, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal cancers and neuroblastoma, as well as ROS1-positive NSCLC.

Results showed Rozlytrek shrank tumors in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumors (overall response rate [ORR]=63.5), and objective responses were observed across 14 tumor types (median duration of response [DoR]=12.9 months.

In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumors in 73.4% of people, with a median DoR of 16.5 months. In a group of 161 patients with a minimum of 6 months follow up, including 29% of patients with central nervous system (CNS) metastases at baseline, ORR was observed to be 67%.

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