FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors
| العنوان: | FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors |
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| المؤلفون: | 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 |
| المصدر: | Clinical Cancer Research. |
| بيانات النشر: | American Association for Cancer Research (AACR), 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | 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. |
| تدمد: | 1557-3265 1078-0432 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::8672b668b5c656a9b30b7d69b31a086a https://doi.org/10.1158/1078-0432.ccr-23-0459 |
| رقم الأكسشن: | edsair.doi...........8672b668b5c656a9b30b7d69b31a086a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15573265 10780432 |
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