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== History ==
Selpercatinib
Selpercatinib was approved based on the results of the LIBRETTO-001 clinical trial (NCT03157128) involving 702 participants aged 15–92 years with each of the three types of tumors.<ref name="FDA PR" /><ref name="Lilly PR" /><ref name="FDA snapshot" /> During the clinical trial, participants received 160 mg selpercatinib orally twice daily until disease progression or unacceptable toxicity.<ref name="FDA PR" /> The major efficacy outcome measures were overall response rate (ORR), which reflects the percentage of participants that had a certain amount of tumor shrinkage, and duration of response (DOR).<ref name="FDA PR" /> The trial was conducted at 84 sites in the United States, Canada, Australia, Hong Kong, Japan, South Korea, Singapore, Taiwan, Switzerland, Germany, Denmark, Spain, France, the United Kingdom, Italy and Israel.<ref name="FDA snapshot" /> The conversion to regular approval for non-small cell lung cancer (NSCLC) was based on data from an additional 172 participants and 18 months of additional follow-up to assess durability of response.<ref name="FDA PR 20220921b" />
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On 10 December 2020, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Retsevmo, intended for the treatment of cancers that display rearranged during transfection (RET) gene alterations: RET-fusion positive non-small cell lung cancer (NSCLC), RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer (MTC).<ref>{{cite web | title=Retsevmo: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=11 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/retsevmo | access-date=11 December 2020 | archive-date=11 December 2020 | archive-url=https://web.archive.org/web/20201211130702/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/retsevmo | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> The applicant for this medicinal product is Eli Lilly Nederland B.V. Selpercatinib was approved for medical use in the European Union in February 2021.<ref name="Retsevmo EPAR">{{cite web | title=Retsevmo EPAR | website=[[European Medicines Agency]] (EMA) | date=9 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo | access-date=23 April 2021 | archive-date=23 April 2021 | archive-url=https://web.archive.org/web/20210423191012/https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
In June 2024, the Food and Drug Administration granted traditional approval to selpercatinib, under the brand name "Retevmo" for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The applicant was Eli Lilly and Company.
== References ==
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