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FDA Approves Lilly's Retevmo, the First and Only RET Inhibitor For Solid Tumor Indications

  • The FDA has approved Eli Lilly And Co’s LLY Retevmo (selpercatinib, 40 mg & 80 mg capsules) for solid tumors.
  • The approval comes for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. 
  • This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication depends on clinical benefit in the confirmatory trial.
  • The company said that in the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across various tumor types, with an overall response rate of 44%.
  • In addition to the tumor-agnostic approval, the FDA has granted traditional approval for Retevmo in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion. 
  • This FDA action broadens the Retevmo label to include patients with locally advanced diseases and converts the May 2020 accelerated approval for NSCLC to a traditional approval.
  • Price Action: LLY shares are up 2.10% at $302.70 during the premarket session on the last check Thursday.

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