Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03157128 (A Phase 1/2 Study of Oral Selpercatinib), which is not on this map. Cited by 55 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)
Who cites it
55 citing papers in PubMed, 73 citations in OpenAlex.
- Molecular biomarkers for diagnosis, prognosis, precision therapy, and immunotherapy in cholangiocarcinoma, cHCC-CCA, and HCC.Hepatology communications · 2026Review
- A predictive model for fusion gene positivity in treatment-naive advanced non-small cell lung cancer.Translational lung cancer research · 2026Article
- Precision Medicine in Pancreatic Cancer: Targeting KRAS and Beyond.Targeted oncology · 2026Review
- Implementation Benchmark of Tumor-Agnostic Eligibility Signals Across Routine Comprehensive Genomic Profiling Platforms in Japan: A Nationwide C-CAT Analysis.Current oncology (Toronto, Ont.) · 2026Article
- Article
- Durable Response to Selpercatinib in Metastatic Colorectal Cancer Harboring a NovelCurrent oncology (Toronto, Ont.) · 2026Article
- Comprehensive Genomic Profiling of Cutaneous Adnexal Carcinomas: A Genomic Landscape Study.Dermatopathology (Basel, Switzerland) · 2026Article
- Review
- Review
- Evaluating the Cost of Genomic Testing for Biomarker-Driven Therapies in Oncology.Oncology and therapy · 2026Article
- Recent advances in molecular classification and multimodal treatment of intrahepatic cholangiocarcinoma.World journal of surgical oncology · 2026Review
- Advancing systemic therapy for biliary tract cancer: current strategies and emerging paradigms.Frontiers in oncology · 2026Review
- BRAF V600E-mutated metastatic Wilms tumor with complete response to targeted RAF/MEK inhibition: a post-treatment follow-up case report.Frontiers in oncology · 2026Article
- Evidence and gaps in tumor-agnostic therapies for breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Review
- The PLEKHA1-TACC2 fusion gene drives tumorigenesis via vascular mimicry formation in esophageal squamous-cell carcinoma.Cell death and differentiation · 2025Article
- Review
- Molecular mechanisms and genetic features of cholangiocarcinoma: implications for targeted therapeutic strategies.Precision clinical medicine · 2025Review
- Embracing and implementing the WHO cervical cancer elimination campaign goals: A consensus statement by SGO, ACOG, ASCCP, ASTRO, and ABS on minimum quality care standards for cervical cancer patients in the U.S.Gynecologic oncology · 2025Article
- Agnostic Biomarkers and Molecular Signatures in Colorectal Cancer-Guiding Chemotherapy and Predicting Response.Biomedicines · 2025Review
- Tumour-agnostic kinase inhibitors.Nature reviews. Drug discovery · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 3 institutions in 1 country.
Funding
Abstract
On September 21, 2022, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the treatment of adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. The approval was based on data from Study LOXO-RET-17001 (LIBRETTO-001; NCT03157128), an international, non-randomized, multi-cohort clinical trial that included patients with advanced solid tumors harboring RET alterations. The overall response rate in 41 patients with locally advanced or metastatic RET fusion-positive solid tumors other than non-small cell lung cancer (NSCLC) or thyroid cancer was 44% [95% confidence interval (CI), 28%-60%], with median duration of response 24.5 months (95% CI, 9.2-not evaluable). Patients with 10 of 14 tumor types with a variety of fusion partners had objective responses, including patients with the following tumors: pancreatic adenocarcinoma, colorectal, salivary, unknown primary, breast, soft-tissue sarcoma, bronchial carcinoid, ovarian, small intestine, and cholangiocarcinoma. The recommendation for approval was supported by results from LIBRETTO-001 in patients with RET fusion-positive NSCLC and thyroid cancer, which formed the basis of prior approvals in these tumor types. The most common adverse reactions (>25%) were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. This is the first tissue-agnostic approval of a RET-directed targeted therapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.