The company, through its new drug application (NDA), has been seeking FDA approval for selpercatinib for the treatment of advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET fusion-positive thyroid cancer, and RET-mutant medullary thyroid cancer (MTC).
The NDA for the oral RET inhibitor is based on the results of the phase 1/2 LIBRETTO-001 trial held in patients with RET-altered lung and thyroid cancers.
In September 2019, Lilly, while releasing the results of the dose-escalation cum dose-expansion study, said that the oral RET inhibitor delivered a 68% objective response rate and sustained durability in heavily pre-treated RET fusion-positive NSCLC.
The FDA set a Prescription Drug User Fee Act (PDUFA) date in the third quarter of 2020 for taking a decision on selpercatinib’s approval.
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 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 had previously granted the breakthrough therapy designation for the oral RET inhibitor for three indications.
In metastatic RET-fusion-positive NSCLC, the breakthrough therapy designation is for the treatment of patients who need systemic therapy and have progressed after platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy.
In RET-mutant MTC, the designation is for treating patients needing systemic therapy, who have progressed after prior treatment and do not have any acceptable alternative treatment option.
The oral RET inhibitor was also given the FDA breakthrough therapy designation for the treatment of advanced RET-fusion-positive thyroid cancer in patients needing systemic therapy, who have progressed after prior treatment and with no acceptable alternative treatment options.
Lilly gained rights to selpercatinib through its $8bn acquisition of Loxo Oncology last year.