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Retsevmo ® ▼ (selpercatinib)
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Can Retsevmo® (selpercatinib) be given while receiving radiation?
Approximately 6% of the LIBRETTO-001 population received on-study radiation.
Selpercatinib and Concurrent Radiation in LIBRETTO-001
Concurrent palliative radiotherapy was permitted In LIBRETTO-001 with sponsor approval and recommendation to hold selpercatinib for approximately 5 half-lives (approximately 2-3 days) before and after radiation therapy.1
Patients Who Received Selpercatinib and Concurrent Radiation in LIBRETTO-001
As of data cut-off date June 17, 2019, 27 patients received on-study palliative radiation, and 2 patients received curative radiation.2 Sites of radiation included
- bone
- brain
- liver
- lymph node
- lung
- neck, and
- other (acetabulum, axilla, chest, hip, humerus, pancreatic node, pelvis, pleura, rib, sacrum, spine, and tonsil).2
Radiation Treatment-Emergent Adverse Events
Adverse events related to radiation included one grade 1 event of radiation neuropathy in the 20 mg twice daily cohort, and one grade 2 event of radiation necrosis in the 160 mg twice daily cohort.2 Neither event was considered to be related to selpercatinib.2
Upon review of the patients who received on-study radiation, 1 patient with non-small cell lung cancer (NSCLC) in the 160 mg twice daily cohort had symptoms considered to be possibly related to radiation.
The patient presented to a scheduled appointment 4 days after a second round of whole brain radiation. He was sent to the hospital with grade 3 muscular weakness, and grade 2 decreased appetite and malaise. The events were deemed likely due to numerous factors including
- failure to thrive from underlying disease
- whole brain radiation
- hypotension and
- thrush.2
None of the events were considered to be related to selpercatinib.2
LIBRETTO-001 Clinical Trial
LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with rearranged (RET) fusion-positive solid tumors, RET-mutant medullary thyroid cancer, and other tumors with RET activation.1,3-5
LIBRETTO-001 Radiation Exclusion Criteria
Exclusion criteria included radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment.
Exception to this criterion was patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment.1
References
1Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in RET fusion–positive non–small-cell lung cancer. N Engl J Med. 2020;383(9):813-824. https://dx.doi.org/10.1056/NEJMoa2005653
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Phase 1/2 study of LOXO-292 in patients with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated October 12, 2022. Accessed January 10, 2023. https://www.clinicaltrials.gov/ct2/show/NCT03157128
4Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in RET-altered thyroid cancers. N Engl J Med. 2020;383(9):825-835. https://dx.doi.org/10.1056/NEJMoa2005651
5Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 10 January 2023