Retevmo(selpercatinib)

Retevmo (selpercatinib) is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. It is also indicated for adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, and for those with advanced or metastatic thyroid cancer with RET gene fusion who are radioactive iodine-refractory. Additionally, Retevmo is indicated for adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Efficacy findings include a 100.0% disease control rate (DCR) in breast cancer and carcinoid tumors, and a 75.0% clinical benefit rate (CBR) in salivary gland tumors. In sarcoma, the median duration of response was 14.88+.

Safety data indicate that treatment discontinuation due to disease progression occurred in 31.7% of patients, while 9.8% discontinued due to adverse events. The most common adverse reactions (≥25%) included edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The most common Grade 3 or 4 laboratory abnormalities (≥5%) were decreased lymphocytes, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium. The median time on treatment was 6.6 months. Retevmo received accelerated approval on May 8, 2020, and traditional approval on September 21, 2022.