01:45 PM EDT, 05/29/2024 (MT Newswires) -- Eli Lilly's ( LLY ) Retevmo, or selpercatinib, was granted accelerated approval by the US Food and Drug Administration to treat pediatric patients two years of age and older with RET-altered thyroid cancer or solid tumors, the regulator said Wednesday.
Retevmo can be used for patients with advanced or metastatic medullary thyroid cancer with a RET mutation who need systemic therapy and children with advanced or metastatic thyroid cancer with a RET gene fusion who are radioactive iodine-refractory and need systemic therapy, according to the FDA.
Patients with locally advanced or metastatic solid tumors with a RET gene fusion that have worsened after previous systemic treatment or have no other treatment options can also use Retevmo, the regulator said.
The FDA said this is its first approval of a targeted therapy for pediatric patients under 12 years old with RET alterations. Selpercatinib was previously granted accelerated approval for thyroid cancer and solid tumor indications in adults as well as for thyroid cancer in pediatric patients 12 years and older, the FDA added.
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