Initial US Approval

20221

Indications

For the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under FDA accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

Recommended Dose/Route1

  • Less than 50 kg: 160 mg orally, twice daily, with or without food
  • 50 kg or greater: 120 mg orally, twice daily, with or without food
Dose Reductions for Adverse Reactions with Selpercatinib

Dose Reductions for Adverse Reactions with Selpercatinib

Pivotal Study

LIBRETTO-001 (NCT03157128)1,2

Key Inclusion Criteria

Eligible patients were aged 18 years or older with RET-altered cancers, with disease progression on or after previous systemic therapies or no satisfactory therapeutic options, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-23.1,2

Treatment

Selpercatinib, 160 mg orally, twice daily until disease progression or unacceptable toxicity.1,2

Selpercatinib Efficacy Data

Selpercatinib Efficacy Data

Safety

The most common adverse reactions (≥25%) include edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The most common grade 3 or 4 laboratory abnormalities (≥5%) include decreased lymphocytes, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium.1,2

Dosage Interruption due to Adverse Events (AEs): 64%1

Permanent Discontinuation due to AEs: 8%1

References

  1. RETEVMO (selpercatinib). Prescribing information. Eli Lilly and Company; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s008lbl.pdf
  2. Subbiah V, Wolf J, Konda B, et al. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022;23(10):1261-1273. doi:10.1016/S1470-2045(22)00541-1