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FDA grants priority review to selpercatinib for RET-altered NSCLC, thyroid cancer
The FDA granted priority review to selpercatinib for the treatment of advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer, according to a press release from the agent’s manufacturer.
Selpercatinib (Eli Lilly), formerly known as LOXO-292, is an investigational oral agent for cancers that harbor abnormalities in the rearranged during transfection (RET) kinase.
"We are pleased the FDA granted priority review status for the [new drug application] for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers," Anne White, president of Lilly Oncology, said in a company-issued press release. "Combined with the recent opening of our two phase 3 selpercatinib clinical trials, we are thrilled with the positive momentum of this program and hope to deliver a practice-changing treatment to patients with RET-driven cancers as soon as possible."
The FDA formerly granted selpercatinib breakthrough therapy designation for certain patients with advanced RET fusion-positive thyroid cancer and those with RET-altered NSCLC or medullary thyroid cancer, as Healio previously reported. The investigational treatment also received orphan drug designation by the FDA for RET fusion-positive NSCLC and RET fusion-positive and RET-mutant thyroid cancers.
Data from the phase 1/phase 2 LIBRETTO-001 trial, results of which were previously reported by Healio, served as the basis for previous regulatory actions.
The randomized phase 3 LIBRETTO-431 trial will evaluate selpercatinib vs. platinum-based and pemetrexed chemotherapy with or without pembrolizumab (Keytruda, Merck) among 400 patients with advanced or metastatic RET fusion-positive NSCLC who did not receive prior systemic therapy for metastatic disease. Efficacy endpoints include PFS, OS, objective response rate, duration of response and intracranial ORR.
LIBRETTO-531, another randomized phase 3 trial, will investigate selpercatinib vs. physician’s choice of cabozantinib (Cabometyx, Exelixis) or vandetanib (Caprelsa, Sanofi Genzyme) among 400 patients with advanced or metastatic RET mutant medullary thyroid cancer who did not receive prior systemic therapy for metastatic disease. Efficacy endpoints include PFS, OS, treatment failure-free survival and duration of response.