FDA Conditionally Approves Eli Lilly's Thyroid Cancer Drug For Pediatric Patients With Certain Mutations
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval to Eli Lilly's (NYSE:LLY) drug selpercatinib (Retevmo) for pediatric patients with certain RET mutations in thyroid cancer. This marks the first FDA approval of targeted therapy for pediatric patients under 12 years of age with RET alterations. The approval is based on the LIBRETTO-121 study, which showed a confirmed overall response rate (ORR) of 48% and durable responses in pediatric and young adult patients.
May 29, 2024 | 7:02 pm
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Eli Lilly's selpercatinib (Retevmo) has received FDA accelerated approval for pediatric patients with certain RET mutations in thyroid cancer. This is the first targeted therapy approval for children under 12 with RET alterations, potentially expanding the market for this drug.
The FDA's accelerated approval for selpercatinib in pediatric patients with RET mutations is a significant milestone for Eli Lilly. This approval not only expands the potential market for the drug but also positions Eli Lilly as a leader in pediatric oncology treatments. The positive clinical trial results further support the drug's efficacy, likely boosting investor confidence and driving short-term stock price appreciation.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100