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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Overview of attention for article published in Clinical Cancer Research, June 2023
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About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (85th percentile)
  • Good Attention Score compared to outputs of the same age and source (68th percentile)

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Title
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors
Published in
Clinical Cancer Research, June 2023
DOI 10.1158/1078-0432.ccr-23-0459
Pubmed ID
Authors

Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh

Abstract

On September 21, 2022, the U.S. Food and Drug Administration (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 which included patients with advanced solid tumors harboring RET alterations. The overall response rate (ORR) 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% 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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Attention Score in Context

This research output has an Altmetric Attention Score of 10. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 06 June 2023.
All research outputs
#3,457,522
of 23,933,166 outputs
Outputs from Clinical Cancer Research
#3,039
of 12,846 outputs
Outputs of similar age
#28,652
of 201,553 outputs
Outputs of similar age from Clinical Cancer Research
#28
of 85 outputs
Altmetric has tracked 23,933,166 research outputs across all sources so far. Compared to these this one has done well and is in the 85th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 12,846 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 11.3. This one has done well, scoring higher than 76% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 201,553 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 85% of its contemporaries.
We're also able to compare this research output to 85 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 68% of its contemporaries.