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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