FDA grants accelerated approval for Retevmo in younger thyroid cancer patients

30 May 2024

The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly (NYSE: LLY) for pediatric patients two years of age and older with the following:

advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy;
advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); and
locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

The FDA granted accelerated approval to Retevmo for adults with locally advanced or metastatic solid tumors with a RET gene fusion in September 2020. In May 2020, the agency approved Retevmo to treat non-small cell lung cancer (NSCLC), medullary thyroid cancer, and other types of thyroid cancers in patients whose tumors have an alteration in a specific gene.

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