FDA Approves Retevmo for Certain Lung, Thyroid Cancers
Approval indicated for NSCLC, medullary thyroid cancer, other thyroid cancers with RET gene alteration
MONDAY, May 11, 2020 (HealthDay News) -- Retevmo (selpercatinib) capsules have been approved to treat patients with non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and other thyroid cancers with an alteration in the "rearranged during transfection" (RET) gene, the U.S. Food and Drug Administration announced Friday.
Retevmo was approved for adults with metastatic NSCLC and patients aged 12 years and older with advanced or metastatic MTC requiring systemic therapy or advanced RET fusion-positive thyroid cancer requiring systemic therapy that has stopped responding to or is not appropriate for radioactive iodine (RAI) therapy. Before a patient initiates Retevmo treatment, presence of the RET gene alteration must be identified through laboratory testing.
Clinical trial results from patients with each of the three types of tumors were used to approve Retevmo. Patients in the clinical trial received 160 mg Retevmo orally twice daily until disease progression or toxicity. Overall response rates were: 64 percent among 105 patients with RET fusion-positive NSCLC previously treated with platinum chemotherapy; 84 percent for 39 treatment-naive patients with RET-positive NSCLC; 69 percent for 55 patients with advanced or metastatic RET-mutant MTC previously treated with cabozantinib, vandetanib, or both; 73 percent for 88 patients who had not previously received treatment with an approved therapy for MTC; 79 percent for 19 patients with RET-fusion positive thyroid cancer who were RAI-refractory and had previously received another systemic treatment; and 100 percent for eight patients with RET-fusion positive thyroid cancer who were RAI-refractory and had not received previous therapy. The corresponding percentages of patients for whom response lasted at least six months were 81, 58, 76, 61, 87, and 75 percent.
The most commonly reported side effects were increased aspartate aminotransferase and alanine aminotransferase enzymes in the liver, increased blood glucose, decreased white blood cell count, decreased albumin and calcium in the blood, dry mouth, diarrhea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, swelling in the body or limbs, low blood platelet count, increased cholesterol, rash, constipation, and decreased sodium in the blood. Potential serious side effects with Retevmo include hepatotoxicity, elevated blood pressure, QT prolongation, bleeding, and allergic reactions.
Approval was granted to Loxo Oncology, a subsidiary of Eli Lilly and Company.