FDA Approves Rozlytrek for Breast Cancer, Other Solid Tumors with Specific Gene Defect

FDA Approves Rozlytrek for Breast Cancer, Other Solid Tumors with Specific Gene Defect
The U.S. Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) as an oral treatment for adult and adolescent patients whose breast cancer and other solid tumors have a specific genetic defect called NTRK gene fusion, have no other satisfactory therapy, is metastatic, or likely to experience severe complications are after surgical removal. Rozlytrek also was approved by the FDA for adults with ROS1 mutation-positive, metastatic non-small cell lung cancer. Both ROS1 and NTRK1/2/3 fusions with other genes can result in cancer cell proliferation. By blocking the enzymatic activity of the TRK A/B/C and ROS1 proteins, Genentech’s Rozlytrek may result in the death of tumor cells. Rozlytrek’s effectiveness was evaluated in four clinical trials of 54 adults: the STARTRK-2 Phase 2 trial (NCT02568267), and the Phase 1 studies STARTRK-1 (NCT02097810), ALKA-372-001 and STARTRK-NG (NCT02650401). Both STARTRK-2 and STARTRK-NG trials are still enrolling participants; for more information, on their NCT identifiers. The most common cancer locations were the breast, lung, salivary gland, thyroid, and colon/rectum. The results in
Subscribe or to access all post and page content.