Eli Lilly wins FDA approval for solid tumor therapy [Seeking Alpha]
Eli Lilly and Company (LLY)
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Eli Lilly wins FDA approval for solid tumor therapySep. 22, 2022 6:58 AM ETEli Lilly and Company (LLY)By:Dulan LokuwithanaSA News Editorjetcityimage/iStock Editorial via Getty ImagesNYSE:Thecompany is required to show the clinical benefit of Retevmo to receive continued approval for this indication.The decision was based on data from the pivotal LIBRETTO-001 trial, which indicated Retevmoâ??s effect on overall response rate (ORR) and duration of response (DOR) across multiple tumor types.Specifically, the approval allows LLY to market the treatment, also known as selpercatinib, to treat adults with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion.The treatment is indicated for those whose cancer has advanced despite prior systemic therapy or who have no satisfactory alternative treatment options.Simultaneously, LLY announced that the FDA converted the May 2020 accelerated approval granted for Retevmo to a traditional approval targetin
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- LLY's page on the SEC website