Noted This Week

The FDA granted accelerated approval to selpercatinib (Retevmo; Eli Lilly) to treat adults with locally advanced or metastatic solid tumors with a RET gene fusion whose cancer has advanced on or after a systemic treatment or who have no other satisfactory therapeutic options. Data from the LIBRETTO-001 trial showed that selpercatinib yielded clinically meaningful and durable responses across a variety of tumor types, including pancreatic and colon cancers, in patients with RET-driven malignancies. The agency also granted regular approval to selpercatinib for the treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion; the drug had received accelerated approval for this indication in 2020.

More Noted This Week, September 16–22   »