Lilly’s Retevmo lands new accelerated approval for pediatric cancers

The FDA on Wednesday granted another accelerated approval to Eli Lilly’s cancer drug Retevmo, this time for pediatric patients age 2 and older with certain types of thyroid cancer and solid tumors with a piece of DNA from the RET gene that fuses with another gene.

Efficacy for the pediatric indications was evaluated by the FDA in a Phase 1/2 study known as LIBRETTO-121, which began in 2019 as part of a written request from the FDA under the Best Pharmaceuticals for Children Act. In the trial, the drug had an overall response rate of 48%, with 92% of those patients still in response at 12 months.

Retevmo is a kinase inhibitor that’s known generically as selpercatinib. It’s won a series of regulatory clearances, including converting an accelerated approval to a full approval in September 2022 for patients with locally advanced or metastatic non-small cell lung cancer with a RET gene fusion. And in 2022, it won an accelerated approval for adults with locally advanced or metastatic solid tumors with a RET gene fusion and whose cancers had come back after chemotherapy or who had run out of other options.

Retevmo was a key part of Lilly’s $8 billion purchase of Loxo Oncology in 2019 and brought in $444 million in revenue in 2022 and 2023 for Lilly.

The most common adverse reactions in the LIBRETTO-121 trial included musculoskeletal pain, vomiting, abdominal pain and hemorrhage. The FDA said the most common grade 3 or 4 abnormalities were decreased calcium, hemoglobin and neutrophils.

Lilly did not immediately respond to a request for comment.

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