FDA approved selpercatinib for RET fusion+ advanced solid tumors

The U.S. Food and Drug Administration has approved selpercatinib (Retevmo; Eli Lilly) 40 mg & 80 mg capsules for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options, according to a press release.

This indication is approved under accelerated approval based on ORR and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

In addition, the FDA granted traditional approval for selpercatinib in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. This converts the May 2020 accelerated approval for NSCLC to a traditional approval as well as includes patients with locally advanced disease.

Read the full press release here.