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FDA Approval for Retevmo (selpercatinib)

Tuesday, May 12, 2020   (0 Comments)
Posted by: Judy Dallas
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Based on the clinical trial results from the LIBRETTO-001 (NCT03157128) Phase 1/2 trial in RET-altered thyroid cancer, RetevmoTM (selpercatinib) is now approved to treat advanced medullary thyroid cancer (MTC) or MTC that has spread, in patients 12 years old and older who require systemic therapy; and in advanced or metastatic RET fusion-positive thyroid cancer in those age 12 and older that requires systemic therapy and has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy. ITOG collaborated with Loxo Oncology at Lilly to participate in LIBRETTO-001, supporting enrollment of patients with RET-driven thyroid cancer. Many ITOG members played a key role in the design, conduct and successful completion of this pivotal trial.  ITOG member, Lori J. Wirth, MD, presented the registrational  results of LOXO-292 [Retevmo (selpercatinib)]  in patients with RET-altered thyroid cancers at the European Society for Medical Oncology Congress 2019 in Barcelona, Spain, in September, 2019. Dr. Wirth noted, “The approval of selpercatinib for RET-mutant MTC and iodine-refractory RET-fusion thyroid cancers now offers our patients a new option of gene-specific therapy, the first of its kind for patients with RET-altered thyroid cancers.”

 


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