Eli Lilly and Company (LLY) on Tuesday received traditional approval from the US Food and Drug Administration for its drug selpercatinib, Retevmo, to treat adult and pediatric patients two years and older with locally advanced or metastatic solid tumors carrying a RET gene fusion, a genetic alteration that can drive tumor growth.

The approval applies to patients who have progressed on prior treatment or have no satisfactory alternative options, as detected by an FDA-approved test.

The drug previously held accelerated approval for this indication, the notice said.

In a trial of 75 patients with RET fusion-positive tumors outside of lung and thyroid cancer, the drug showed a 47% overall response rate, or share of patients whose tumors shrank significantly, with a median response duration of 24.5 months.

The FDA approved the application two months ahead of schedule, and the drug holds orphan drug designation for this tissue-agnostic indication, meaning it applies regardless of where the tumor originated.

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