Lilly Files New Paediatric Solid Tumour Indication for Retevmo in China

Lilly has filed for approval of RET inhibitor Retevmo (selpercatinib) in China for paediatric patients with RET fusion-positive advanced solid tumours, based on Phase I/II LIBRETTO-121 trial data showing 36% objective response rate and 86% 24-month progression-free survival (PFS) in 36 evaluable children. The oral therapy previously gained Chinese approval in 2022 for RET-altered non-small cell lung cancer (NSCLC) and thyroid cancer in adults and adolescents aged 12+.

The new application expands Retevmo's potential in rare paediatric cancers, where it demonstrated 100% 24-month duration of response (DOR) across RET-mutant medullary thyroid cancer (40% ORR) and RET fusion-positive papillary thyroid cancer (33.3% ORR) subgroups. As the first selective RET inhibitor approved globally in 2020, Retevmo addresses critical unmet needs in genomically defined cancers affecting approximately 2% of solid tumour patients.

According to PharmCube's NextBiopharm® database, Retevmo has been put into development for 17 different diseases so far. Click here to request a free trial for NextBiopharm®.

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