Eli Lilly’s Retevmo (selpercatinib) Receives the US FDA’s Approval as the First Therapy to Treat Advanced RET-Driven Lung and Thyroid Cancers
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Shots:
- Approval is based on LIBRETTO-001 P-I/II study, which is assessing Retevmo (selpercatinib, 40 mg & 80 mg capsules) in 702 patients with both treatment-naive and heavily pre-treated solid tumour patients (incl. RET fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer, and other solid tumors with RET alterations)
- The P-I/II study results (treatment naïve; treatment experienced): RET Fusion-Positive NSCLC (N=39; 105), ORR (85%; 64%), mDOR (NR vs 17.5 mos.); RET-mutant MTC (N=88; 55) ORR (73%; 69%), mDOR (22 mos.; NR), RET Fusion-Positive Thyroid Cancers (N= 8, 19), ORR (100%; 79%), mDOR (NR; 7.6 mos.)
- Retevmo (formerly LOXO-292) is an oral selective RET kinase inhibitor (120/160mg by -/+50kg weight) BID, and has also received the FDA ODD for RET fusion +ve NSCLC, RET fusion +ve & RET-mutant thyroid cancers, undifferentiated or anaplastic thyroid cancer, MTC aand LA or metastatic follicular or papillary thyroid cancer
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