On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020.
Previously, the FDA granted breakthrough therapy and orphan drug designations for selpercatinib to treat certain patients with advanced RET fusion-positive thyroid cancer and those with RET-altered NSCLC or MTC. The agent was also granted orphan drug designation by the FDA for the treatment of patients with RET fusion-positive NSCLC, RET-mutant MTC, and RET fusion-positive thyroid cancer.
“We are pleased the FDA granted priority review status for the NDA for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers,” stated Anne E. White, President, Lilly Oncology, in a company press release.
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