Eli Lilly has received priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) of selpercatinib (LOXO-292) to treat lung and thyroid cancers.

The company is seeking approval for the drug in advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), as well as RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

Selpercatinib is an investigational drug developed to treat cancers with RET kinase abnormalities occurring in numerous types of tumours. The drug selectively blocks RET signalling and predicted acquired resistance mechanisms.

The NDA includes results from Phase I / II LIBRETTO-001 clinical trial in patients with RET-altered lung and thyroid cancers. Phase I of the study focuses on dose escalation, while Phase II centres around dose expansion.

The primary endpoint of the Phase II part was the objective response rate, while secondary endpoints were duration of response, progression-free survival and safety.

FDA is set to provide its decision on the approval of selpercatinib in the third quarter of this year.

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By GlobalData

Lilly Oncology president Anne White said: “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.

“Combined with the recent opening of our two Phase III 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.”

Previously, the FDA awarded breakthrough therapy and orphan drug designations for selpercatinib in patients with RET-fusion-positive NSCLC, RET-mutant MTC and RET-fusion-positive thyroid cancer.

Last month, the company launched two Phase III trials of the drug, namely LIBRETTO-431 in treatment-naïve RET fusion-positive NSCLC, and LIBRETTO-531 in treatment-naïve RET-mutant MTC.

Last October, Lilly obtained the FDA approval for Reyvow in the acute treatment of adults suffering from migraine, with or without aura.