Roche: FDA Approves Genentech’s Personalized Medicine for Two Different Indications in ROS1-Positive Non-Small Cell Lung Cancer and NTRK Fusion-Positive Solid Tumors Donnerstag, 15. August 2019 - 22:27
On August 15, 2019, the FDA approved Genentech’s Rozlytrek® (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a 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 either progressed following treatment or have no satisfactory alternative therapy. The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumor response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.
- Rozlytrek is the first FDA-approved treatment selected to target both NTRK and ROS1 fusions that has also shown response in cancer that has spread to the brain.
- Rozlytrek is Genentech’s first FDA-approved tumor-agnostic medicine.
- Biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumors is the only way to identify people who are eligible for treatment with Rozlytrek.
"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. Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”
Sandra Horning, M.D., Chief Medical Officer and head of Gl