Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
INDIANAPOLIS,?Jan. 29, 2020/PRNewswire/ --?Eli Lilly and Company(NYSE: LLY) announced today that the?U.S. Food and Drug Administration?(FDA)?has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients?with advanced?RET?fusion-positive non-small cell lung cancer (NSCLC),?RET-mutant medullary thyroid cancer (MTC) and?RET?fusion-positive thyroid cancer. The NDA is based on data from the LIBRETTO-001 Phase 1/2 trial?in?RET-altered lung and thyroid cancers. The?FDA?has filed the NDA and set a Prescription Drug User Fee Act (PDUFA) date in the third quarter of this year.
"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," said?Anne White, president of Lilly Oncology. "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."
In previous regulatory actions, based on early data from the Phase 1/2 LIBRETTO-001 trial, the?FDA?granted selpercatinib Breakthrough Therapy Designation for treatment in people with:
- Metastatic?RET-fusion-positive NSCLC who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy;
- RET-mutant MTC who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment option; and
- Advanced?RET-fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
Refer to: | Becky Polston;?becky.polston@lilly.com; 317-796-1028 (Lilly) ? media |
Kevin Hern;?hern_kevin_r@lilly.com; 317-277-1838 (Lilly) ? investors |
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SOURCE?Eli Lilly and Company