Retsevmo ® ▼ (selpercatinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

What were the exclusion criteria for Retsevmo® ▼ (selpercatinib) and concurrent radiation?

Palliative limited field radiotherapy within one week of starting selpercatinib was not allowed unless >30% of the bone marrow was radiated. A wide field of radiation had to be completed >4 weeks before the first dose.

UK_cFAQ_SEL110_CONCURRENT_RADIATION
UK_cFAQ_SEL110_CONCURRENT_RADIATION
en-GB

Trial Exclusion Criteria Regarding Radiation

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

Concurrent Radiation

Concurrent palliative radiotherapy was permitted with Sponsor approval and recommended selpercatinib dosing. As of data cut-off date June 17, 2019, 27 patients received on-study palliative and 2 patients received curative radiation. Sites of radiation include 

  • bone
  • brain
  • liver
  • lymph node
  • lung
  • neck, and
  • other.1

Radiation by site and dose are presented in Episodes of Radiation Therapy by Selpercatinib Starting Dose.

Episodes of Radiation Therapy by Selpercatinib Starting Dose1


Site, nab

Selpercatinib Starting Dose

20 mg daily

20 mg
twice daily

40 mg
twice daily

60 mg
twice daily

80 mg
twice daily

120 mg
twice daily

160 mg
twice daily

Bone

2

---

1

---

3

---

5

Brain

1

1

---

2

---

3

4

Liver

---

---

1

---

---

---

1

Lymph node

---

---

---

---

---

---

1

Lung

---

---

---

---

---

---

1

Neck

---

---

---

---

---

---

2

Otherc

---

2

---

1

---

---

1

aMore than 1 site may be attributed to 1 patient.

bData cut-off June 17, 2019.

cIncluded acetabulum, axilla, chest, hip, humerus, pancreatic node, pelvis, pleura, rib, sacrum, spine, and tonsil.

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.1 Neither event was considered to be related to selpercatinib.1

Upon review of the 29 patients who received on-study radiation, 1 patient with NSCLC in the 160 mg twice daily cohort had symptoms considered to be possibly be 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.1

None of the events were considered to be related to selpercatinib.1

Dose Modification

In the clinical trial, it was recommended to hold selpercatinib for approximately 5 half-lives (approximately 2-3 days) before and after radiation therapy.1

LIBRETTO-001 Clinical Trial

LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with RET fusion-positive solid tumors, RET-mutant MTC, and other tumors with RET activation.2-5

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2A study of selpercatinib (LOXO-292) in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001) (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated March 10, 2022. Accessed March 17, 2022. https://www.clinicaltrials.gov/ct2/show/NCT03157128

3Wirth 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

4Drilon 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

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: 01 February 2021


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