Drugs / Selpercatinib
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | RETEVMO | — | 2022-09-21 – 2026-07-14 | fda.gov ↗ |
| Approved | EU (EMA) | Retsevmo | — | 2021-02-11 | europa.eu ↗ |
| Approved | US (FDA) | RETEVMO | — | 2020-05-08 | fda.gov ↗ |
| Filed | China (NMPA) | Retsevmo | non-small cell lung cancer, medullary thyroid cancer, RET fusion-positive thyroid cancer | — | “In China, the NDA for Retsevmo® (selpercatinib) for the above indications was accepted by NMPA and granted priority review in August 2021.” innoventbio.com ↗ “the NDA for selpercatinib was accepted by the Center for Drug Evaluation (CDE) of NMPA in China” innoventbio.com ↗ “Retsevmo®(selpercatinib), NDA accepted” innoventbio.com ↗ “Retsevmo®（selpercatinib），NDA submitted” innoventbio.com ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07146893 | Feb 2026 → Feb 2027 expected | — | University of Oklahoma | Not yet recruiting | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT05906836 | Jul → Oct 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05324124 | Apr → Jun 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05136404 | Dec 2021 → Mar 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05089019 | Oct 2021 → Jul 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04782076 | Mar → May 2021 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05338502 | Jul → Sep 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05630274 | Apr → Jun 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338515 | Feb → Mar 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05469113 | Jan → Mar 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05469100 | Dec 2018 → Aug 2019 | impaired renal function disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05436912 | Dec 2018 → Oct 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05630287 | Aug → Sep 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338476 | Jul → Aug 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05468164 | May → Sep 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338489 | May → Jul 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03899792 | Jun 2019 → Nov 2024 overdue | fibrosarcoma, infantile myofibromatosis, medullary thyroid gland carcinoma, thyroid gland papillary carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03157128 | May 2017 → Feb 2025 overdue | colon carcinoma, medullary thyroid gland carcinoma, non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06458036 | Jul 2024 → Nov 2030 expected | childhood malignant neoplasm, differentiated thyroid carcinoma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 2 | NCT05668962 | Mar 2023 → Mar 2025 overdue | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05364645 | Jul 2022 → Jun 2023 | non-small cell lung carcinoma | SWOG Cancer Research Network | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04320888 | May 2021 → Sep 2024 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, ependymoma +10 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04759911 | Feb 2021 → Nov 2027 expected | medullary thyroid gland carcinoma, poorly differentiated thyroid gland carcinoma, thyroid gland papillary carcinoma, thyroid gland squamous cell carcinoma +1 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04268550 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04280081 | Mar 2020 → Mar 2021 overdue | medullary thyroid gland carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 33 trials · 3 met primary | ||||||
| Phase 3 | NCT04819100 | Dec 2021 → Jan 2026 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT04194944 | Feb 2020 → May 2023 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT04211337 | Feb 2020 → May 2023 overdue | medullary thyroid gland carcinoma | Loxo Oncology, Inc. | Active not recruiting | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07822880 | Oct 2026 → Oct 2029 expected | non-small cell lung carcinoma, thyroid tumor | Eli Lilly and Company | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03906331 | — | RET fusion positive cancer, breast cancer, colon carcinoma, malignant pancreatic neoplasm +3 | Eli Lilly and Company | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Eli Lilly and Company | Results Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancer lilly.com ↗
The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) with selpercatinib reducing the risk of disease recurrence or death by 83% versus placebo in the primary analysis population. |
| 2026-02-16 | Eli Lilly and Company | Results Lilly's Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer lilly.com ↗
The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) in patients with early-stage (II-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). |
| 2025-12-07 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List innoventbio.com ↗
We are pleased with the NRDL inclusion of our seven innovative therapies this year. |
| 2023-10-21 | Eli Lilly and Company | Results Lilly's Retevmo® (selpercatinib) Phase 3 Results in RET Fusion-Positive Non-Small Cell Lung Cancer and RET-Mutant Medullary Thyroid Cancer Both Published in The New England Journal of Medicine and Presented in a Presidential Symposium at ESMO Congress 2023 lilly.com ↗ |
| 2023-08-22 | Eli Lilly and Company | Results Lilly's Retevmo® (selpercatinib) Demonstrates Superior Progression-Free Survival Compared to Approved Multikinase Inhibitors in RET-Mutant Medullary Thyroid Cancer lilly.com ↗
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). |
| 2023-08-04 | Eli Lilly and Company | Results Lilly's Retevmo® (selpercatinib) is the First Targeted Therapy to Demonstrate Superior Progression-Free Survival Compared to a PD-1 Inhibitor Plus Chemotherapy for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer lilly.com ↗
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). |
| 2022-10-10 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory The China NMPA Approves Selpercatinib for the Treatment of Patients with RET-driven Lung and Thyroid Cancers innoventbio.com ↗ |
| 2022-09-21 | Eli Lilly and Company | Regulatory FDA Approves Lilly's Retevmo® (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type lilly.com ↗
This indication is approved under accelerated approval based on ORR and duration of response (DOR). |
| 2022-04-01 | Eli Lilly and Company | Results Lilly Presents Updated Data on Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Non-Small-Cell Lung Cancer (NSCLC) at the 2022 European Lung Cancer Congress lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo® (selpercatinib 40 mg & 80 mg capsules) in patients with RET fusion-positive non-small cell lung cancer (NSCLC). |
| 2021-04-11 | Eli Lilly and Company | Results Lilly Presents New Data on Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced for the first time data from the Phase 1/2 LIBRETTO-001 trial showing treatment with Retevmo® (selpercatinib) demonstrated encouraging antitumor activity and safety across RET fusion-positive advanced solid tumors beyond lung and thyroid cancers, including multiple treatment-refractory gastrointestinal (GI) malignancies. |
| 2020-08-27 | Eli Lilly and Company | Results New England Journal of Medicine Publishes Phase 1/2 Data for Retevmo™ (selpercatinib) in Advanced RET-Driven Lung and Thyroid Cancers lilly.com ↗
NEJM published separate articles focusing on efficacy and safety data in the RET fusion-positive NSCLC and RET-altered thyroid patient cohorts independently, with data demonstrating durable objective responses across both patient populations. |
| 2020-05-08 | Eli Lilly and Company | Regulatory Lilly Receives U.S. FDA Approval for Retevmo™ (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers lilly.com ↗
Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of objective response rate (ORR) and duration of response (DoR). |
| 2020-01-29 | Eli Lilly and Company | Regulatory Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application lilly.com ↗
We are pleased the FDA granted priority review status for the NDA for selpercatinib. |
| 2019-09-29 | Eli Lilly and Company | Results Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers lilly.com ↗
In the RET-mutant MTC registration dataset consisting of the first 55 enrolled patients with prior cabozantinib and/or vandetanib2, selpercatinib treatment resulted in a 56 percent objective response rate (ORR) (95% CI: 42-70%). |
| 2019-09-09 | Eli Lilly and Company | Results Lilly 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 lilly.com ↗
In the registration dataset consisting of the first 105 enrolled RET fusion-positive NSCLC patients with prior platinum-based chemotherapy, selpercatinib treatment resulted in a 68 percent objective response rate (ORR) (95% CI: 58-76%). |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Selpercatinib | “This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also...” NCT03157128 ↗37“Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “Selpercatinib” NCT04817956 ↗ |
| Known as | LOXO-292 | “This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also...” NCT03157128 ↗1“A Phase 2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including Rearranged in Transfection (RET) Fusion-Positive Solid Tumors, Medullary...” NCT04280081 ↗ |
| Known as | LY3527723 | “A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation” NCT04280081 ↗ |
| Known as | Ret inhibitor loxo-292 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4559134 ↗ |
| Known as | Retevmo | “Selpercatinib (also known by the brand name Retevmo®/Retsevmo®) is a new treatment available in multiple countries” PMID 35969032 ↗ Aug 2022 |
| Known as | Retsevmo | “Selpercatinib (also known by the brand name Retevmo®/Retsevmo®) is a new treatment available in multiple countries” PMID 35969032 ↗ Aug 2022 |
| Action | Inhibit | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |
| Modality | Small molecule | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |
| Route | Oral | “receive selpercatinib PO BID” NCT03155620 ↗ |
| Target | RET | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |