EC Approves Roche’s Newest Anti-Cancer Drug

Published on: 

Roche has received approval from the European Commission for Rozlytrek (entrectinib), its newest anti-cancer drug, for two indications.

The European Commission (EC) has granted conditional marketing authorization for Rozlytrek (entrectinib), Roche’s tumor-agnostic once-daily oral medicine for treating tumors, in two indications, Roche announced in an Aug. 3, 2020 press release. The drug is indicated for adult and pediatric patients 12 years of age and older with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor nor have had any satisfactory treatment options. The other indication is for treating adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

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

The European Medicines Agency granted the drug Priority Medicines (PRIME) designation. The PRIME designation was for the use of Rozlytrek in the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in patients who have either progressed following prior therapies or who have no acceptable standard therapies. NTRK gene fusions have been identified in a range of solid tumor types and were found to be present in up to 90% of some rare cancer types. In other more common tumors, such as lung and colorectal, the NTRK gene fusion was found in less than 1% of those tumors. ROS1 gene fusions, meanwhile, account for 1%–2% of NSCLC, Roche reported in its press release.

“We are excited to announce the approval of Rozlytrek in Europe for two indications, bringing patients with NTRK and ROS1 gene fusions a new effective treatment even when their cancer has spread to the brain,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in the press release. “This advance represents another important step forward in cancer care by allowing us to treat certain genetic drivers of cancer irrespective of the location of the tumor within the body. Roche is deeply committed to driving personalized healthcare and addressing the high unmet need in patients around the world with rare cancers.”


The drug was granted accelerated approval in the United States by FDA in August 2019, following receipt of breakthrough therapy designation. In the US, the drug is indicated for adult and pediatric patients 12 years of age and older with solid tumors that have a 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. It was also approved for treating adults with ROS1-positive, metastatic NSCLC. In June 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) also approved Rozlytrek for treating adult and pediatric patients with NTRK fusion-positive, advanced recurrent solid tumors, followed by a later approval in February 2020 for treating ROS1-positive NSCLC. Rozlytrek has also received approvals by health authorities in Australia, Canada, Hong Kong, Israel, New Zealand, South Korea, and Taiwan, according to Roche.

Source: Roche