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selpercatinib

Generic: SELPERCATINIB·Brand: RETEVMO, Retevmo

selpercatinib: developed by 1 company · 6 clinical trials tracked · 2 FDA decisions.

selpercatinib evidence translation

What we can confirm

2 FDA records · 6 tracked trials

What it means

Source-backed records connect selpercatinib to LLY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could selpercatinib → LLY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 1 study sponsors

Related indications

Carcinoma, Transitional CellSolid Tumor; Carcinoma, Non-Small-Cell LungCancerSolid Tumor
Development Pipeline (2)
CompanyPhase
ELI LILLY & Co (LLY)
Carcinoma, Transitional Cell
Approved
ELI LILLY & Co (LLY)
Solid Tumor; Carcinoma, Non-Small-Cell Lung
Phase 3
Clinical Trials (6)

LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

NCT04819100·Phase 3·LLY

Primary endpoint: Event-Free Survival (EFS)

InterventionalRandomizedtriple152 targetStarted 2021-12Completion 2028-0550 sites · Australia, Austria, Belgium, Brazil…Eli Lilly and Company

Neoadjuvant Treatment With Selpercatinib in RET-Altered Thyroid Cancers

NCT04759911·Phase 2
Active, not recruiting

Primary endpoint: Objective response rate (ORR)

Interventionalopen30 targetStarted 2021-02Completion 2027-113 sites · United StatesM.D. Anderson Cancer Center

A Phase II Study of LOXO-292 in Patients With RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

NCT04268550·Phase 2
Active, not recruiting

Primary endpoint: Response rate by blinded independent centralized review (BICR)

Interventionalopen124 targetStarted 2020-04Completion 2026-1250 sites · United StatesSWOG Cancer Research Network

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 Thyroid Cancer and Other Tumors With RET Activation

NCT04280081·Phase 2·LLY
Active, not recruiting

Primary endpoint: Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC)

Interventionalopen77 enrolledStarted 2020-03Completion 2028-1113 sites · ChinaEli Lilly and Company

A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

NCT04211337·Phase 3·LOXO
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen291 targetStarted 2020-02Completion 2027-1150 sites · Australia, Belgium, Brazil, Canada…Loxo Oncology, Inc.

A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile

NCT02925234·Phase 2
Recruiting

Primary endpoint: Percentage of patients that are treated based on their molecular tumor profile

Interventionalopen1,550 targetStarted 2016-08Completion 2027-1236 sites · NetherlandsThe Netherlands Cancer Institute
FDA Decisions2 records
Approval(LLY)FDA ↗
NDA218160Type 3 - New Dosage FormOrphan DrugStandardOralTablet
Approval(LLY)FDA ↗
NDA213246Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Who is developing selpercatinib?

selpercatinib is being developed by ELI LILLY & Co.

How many clinical trials involve selpercatinib?

BioSniper tracks 6 clinical trials involving selpercatinib.

What is selpercatinib's latest FDA decision?

The most recent tracked FDA decision for selpercatinib is Approval, dated April 10, 2024.