Why Eli Lilly (LLY) Shares Are Trading Higher Today - Eli Lilly (NYSE:LLY)

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