Retevmo
FDA Grants Full Approval to Eli Lilly's Retevmo in RET-Mutant Medullary Thyroid Cancer
The agency converted a prior accelerated approval to a traditional approval based on results from the LIBRETTO-531 trial.
Eli Lilly Nabs Full FDA Approval for Retevmo in RET Fusion-Positive Thyroid Cancer
In converting a 2020 accelerated approval to a full approval, the agency lowered the RET inhibitor's age restriction from 12 years old to 2 years old.
FDA Lowers Pediatric Age for Eli Lilly's Retevmo
The RET inhibitor can now be given to children with RET-altered cancers as young as 2 years old.
FDA Approves FoundationOne CDx for Eli Lilly's Retevmo
The tissue-based test can determine if Retevmo is an appropriate treatment for patients with RET gene fusions.
Eli Lilly to Share With Regulators Data on Retevmo Besting Standard Drugs in Thyroid Cancer Patients
The Phase III study data showing Retevmo improved progression-free survival in patients with RET-mutant tumors may support conversion from accelerated to full approval.