FDA Approves Lilly Selpercatinib for RET+ Medullary Thyroid Cancer

 The FDA approved selpercatinib (Retevmo) for the treatment of adult and pediatric patients aged 2 years and older with advanced or metastatic, RET-mutant medullary thyroid cancer, as detected by an FDA-approved test, who require systemic therapy, according to the agency.1

The traditional approval was based on efficacy data from the randomized, multicenter, open-label, phase 3 LIBRETTO-531 trial (NCT04211337), designed to evaluate selpercatinib (160 mg twice daily) vs physician’s choice of cabozantinib (Cabometyx; 140 mg once daily) or vandetanib (Caprelsa; 300 mg once daily) in a 2:1 fashion among patients with advanced or metastatic RET-mutant medullary thyroid cancer.

Median progression-free survival (PFS), the trial’s primary end point, was not reached (NR; 95% CI, NE-NE) in the selpercatinib arm, compared with 16.8 months (95% CI, 12.2-25.1) in the physician’s choice arm, reducing the risk for disease worsening by 72% (HR, 0.28; 95% CI, 0.165-0.475; P < .0001).

https://www.oncnursingnews.com/view/fda-approves-selpercatinib-for-ret-medullary-thyroid-cancer