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Retevmo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved May 8, 2020)
Brand name: Retevmo
Generic name: selpercatinib
Dosage form: Capsules
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Retevmo (selpercatinib) is a kinase inhibitor 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.

Development Timeline for Retevmo

May  8, 2020Approval  FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers
Jan 29, 2020Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Dec 30, 2019Lilly Opens Phase 3 Clinical Trial for Selpercatinib (LOXO-292) in RET-Mutant Medullary Thyroid Cancer
Sep 29, 2019Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers
Sep  9, 2019Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer
Oct 15, 2018Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292 for the Treatment of RET Fusion-Positive Thyroid Cancer

Further information

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