by Mike Bassett
— Selpercatinib approved for advanced or metastatic solid tumors that progress on systemic therapy
The FDA granted accelerated approval to selpercatinib (Retevmo) for adults with locally advanced or metastatic solid tumors associated with RET gene fusions, the agency announced on Wednesday.
Selpercatinib’s tumor-agnostic indication is specifically for patients who have progressed on or following systemic treatment, and for those who have no satisfactory alternative options. The RET inhibitor’s initial 2020 accelerated approval, which carried indications for locally advanced or metastatic non-small cell lung cancers (NSCLCs) and thyroid cancers associated with RET gene fusions, has been converted to a full approval, the agency announced.