Regulatory Tracker: Lilly’s Retevmo Secures Pediatric Cancer FDA Nod ###

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1. FDA Approval: The FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors.
2. Indications: The approval includes advanced or metastatic medullary thyroid cancer with a RET mutation, advanced or metastatic thyroid cancer with a RET gene fusion, and locally advanced or metastatic solid tumors with a RET gene fusion.
3. LIBRETTO-121 Trial: The efficacy of selpercatinib was evaluated in the LIBRETTO-121 trial, which showed an overall response rate of 48% and a median duration of response not reached after 12 months of follow-up.
4. First Targeted Therapy: Retevmo is the first targeted therapy approved for pediatric patients under 12 years of age with RET alterations.
5. Dosing: The recommended dose for pediatric patients 2 to less than 12 years of age is based on body surface area, and for patients 12 years and older, it is based on weight.
6. Adverse Reactions: Common adverse reactions include musculoskeletal pain, diarrhea, headache, nausea, vomiting, and fatigue.