Tanja Obradovic: FDA granted approval to selpercatinib for advanced or metastatic medullary thyroid cancer with a RET mutation

Tanja Obradovic shared a post on LinkedIn:

“Outstanding news for patients with metastatic medulary thyroid cancer including pediatric patients of 2 years and older. FDA just granted approval to Selpercatinib to treat patients 2 years of age and older who have advanced or metastatic medullary thyroid cancer with a RET mutation.

Selpercatinib first got accelerated approval for this indication in patients 12 years of age and older and now in patients starting with 2 years of age based on the phase 3 LIBRETTO-531 trial (NCT04211337).

Patients with RET positive metastatic medullary thyroid cancer were randomly assigned to receive selpercatinib or physicians’ choice of cabozantinib or vandetanib.

At a median follow-up of about 15 months, the overall survival (OS) rate was 94.8% in the selpercatinib arm and 85.7% in the physician’s choice arm (cross over to selpercatinib arm was allowed). With this high OS rate truly great news since safety profile was relatively mild.

With this FDA approval selpercatinib gets label expansion as it is already indicated for locally advanced or metastatic non-small cell lung cancer (NSCLC), metastatic thyroid and relapsed/refractory solid tumors with a RET gene fusion.”

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Source: Tanja Obradovic/LinkedIn

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Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.