FDA Awards Traditional Approval to Selpercatinib for RET+ Advanced Solid Tumors

The FDA has granted traditional approval to selpercatinib (Retevmo) for the treatment of adult and pediatric patients 2 years of age and older with 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.¹

The full approval follows accelerated approval for selpercatinib in the same indication in September 2022.²

Regular approval was supported by data from the phase 1/2 LIBRETTO-001 (NCT03157128) and LIBRETTO-121 (NCT03899792) trials, along with data from the agent’s use in RET fusion–positive non–small cell lung cancer (NSCLC) and thyroid cancer.¹

In LIBRETTO-001, patients with RET fusion–positive tumors other than NSCLC and thyroid cancer (n = 75) achieved an overall response rate (ORR) of 47% (95% CI, 35%-59%) and a median duration of response (DOR) of 24.5 months (95% CI, 11.2-49.1).

Data from LIBRETTO-121 demonstrated that selpercatinib generated responses in 1 patient with congenital infantile fibrosarcoma, 1 patient with a spindle cell sarcoma, and patients with RET fusion-positive thyroid cancer.

Notably, selpercatinib previously received full approval in the following indications³:

• Adult patients with locally advanced or metastatic NSCLC with a RET gene fusion, as detected by an FDA-approved test
• Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
• Adult and pediatric patients 2 years of age and older with 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)

References

1. FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. FDA. July 14, 2026. Accessed July 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive
2. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. FDA. September 21, 2022. Accessed July 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-solid-tumors
3. Prescribing information. Retevmo. Updated November 2025. Accessed July 14, 2026. https://uspl.lilly.com/retevmo/retevmo.html#pi