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Review
. 2020 Jul;80(11):1119-1124.
doi: 10.1007/s40265-020-01343-7.

Selpercatinib: First Approval

Anthony Markham  1
Affiliations
Free PMC article
Review

Selpercatinib: First Approval

Anthony Markham. Drugs. 2020 Jul.
Free PMC article

Erratum in

Abstract

Selpercatinib (RETEVMO™) is a receptor tyrosine kinase RET (rearranged during transfection) inhibitor being developed by Loxo Oncology for the treatment of cancers harbouring RET alterations. Based on results from the phase I/II LIBRETTO-001 trial, selpercatinib was recently approved by the US FDA for the treatment of RET fusion-positive non-small-cell lung cancer, RET fusion-positive thyroid cancer and RET-mutant medullary thyroid cancer. This article summarizes the milestones in the development of selpercatinib leading to this first approval.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Figures

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Key milestones in the development of selpercatinib leading to its approval for the treatment of for lung and thyroid cancers with RET gene mutations or fusions. CNS central nervous system, MTC medullary thyroid cancer, NSCLC non-small cell lung cancer
None
Chemical structure of selpercatinib
See this image and copyright information in PMC

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References

    1. Eli Lilly, Loxo Oncology. Lilly completes acquisition of Loxo Oncology [media release]. 15 Feb 2019. http://www.lilly.com.
    1. Subbiah V, Yang D, Velcheti V, et al. State-of-the-Art strategies for targeting RET-dependent cancers. J Clin Oncol. 2020;38(11):1209–1221. doi: 10.1200/JCO.19.02551. - DOI - PMC - PubMed
    1. US Food & Drug Administration. FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions. Media Release. 2020.
    1. Eli Lilly. RETEVMOTM (selpercatinib): US prescribing information. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf. Accessed 2020.
    1. Pfizer. Pfizer completes acquisition of Array Biopharma [media release]. 30 Jul 2019. http://www.pfizer.com.

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