Roche has announced about the approval of Rozlytrek (entrectinib) by the US Food and Drug Administration (FDA) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also approved Rozlytrek for treating adult and paediatric patients who are 12 years of age and older with solid tumors that have 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.
The study of Rozlytrek was based on a number of solid tumor types such as breast, colorectal, neuroendocrine, salivary gland, sarcoma, cholangiocarcinoma, gynaecological, non-small cell lung, pancreatic, and also thyroid cancers. In case of ROS1-positice, metastatic NSCLC, Rozlytrek reduced tumors in 78% people with the disease and the duration of response was in between 1.8 to 36.8 and more months. Rozlytrek was also able to shrink tumors in more than half of the people with NTRK gene fusion-positive, locally advanced or metastatic solid tumors, and objective responses were observed across 10 tumor types. Objective responses to Rozlytrek were noticed in people with central system (CNS) metastases at baseline.
“Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting.” Said Sandra Horning, MD, Roche’s Chief Medicine Officer and Head of Global Product development. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has shown responses in these rare cancer types that have spread to the brain.”
Some of the common side effects of Rozlytrek were constipation, swelling, diarrhoea, nervous system disorders, muscle pain, increased weight, vomiting, joint pain, fatigue, altered sense of taste, dizziness, nausea, shortness of breath, cognitive impairment, cough, fever, and also vision disorders.
The accelerated approval program of FDA allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. The accelerated approval for NTRK gene fusion-positive solid tumors is based on the response rate and response durability of the tumor, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The only way to find out the people who are eligible for treatment with Rozlytrek is through biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumors. Experts in Roche are developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine in order to help identify people with ROS1 and NTRK gene fusions. Foundation Medicine will submit FoundationOne®CDx to the FDA for approval as a companion diagnostic for Rozlytrek and the FDA-approved diagnostic for Rozlytrek is not currently available.
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