Lilly’s RET inhibitor RET inhibitor wins accelerated approval in paediatric cancers

2024-05-29

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临床结果上市批准并购加速审批

The FDA on Wednesday granted Eli Lilly’s selective RET kinase inhibitor Retevmo (selpercatinib) accelerated approval to treat children two years and older with certain RET-mutated thyroid and solid tumours. According to the US regulator, it’s the first targeted cancer therapy for paediatric patients younger than 12 with RET alterations.

Specifically, Retevmo was cleared for advanced or metastatic medullary thyroid cancer with a RET mutation; advanced or metastatic thyroid cancer with a RET gene fusion in patients who are radioactive iodine-refractory; and locally advanced or metastatic solid tumours with a RET gene fusion in patients who have progressed on a prior systemic therapy.

The RET inhibitor RET inhibitor already holds accelerated approval for the thyroid cancer indications in adults and paediatric patients older than 12, as well as the solid tumour indication in adults.

Supporting data

The new paediatric approval was based on results of the Phase I/II LIBRETTO-121 study in 25 patients ages 2 to 20 with locally advanced or metastatic RET-activated solid tumours non-responsive to available therapies.

Retevmo led to a confirmed overall response rate (ORR) of 48%. Additionally, the median duration of response (DOR) was not reached, with 92% of responders still seeing a treatment effect at 12 months.

The most common adverse reactions seen in more than a quarter of patients were musculoskeletal pain, diarrhoea, headache, nausea, vomiting and fatigue, among others.

Lily gained Retevmo through its $8-billion acquisition of Loxo Oncology in 2019.

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