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SELPERCATINIB TAB

Clinical Criteria Summary

Exclusion Criteria

  • Symptomatic CNS metastases
  • GFR < 30 mL/min
  • Uncontrolled hypertension
  • Baseline QTc >470 msec
  • Strong or Moderate CYP3A4 inducers
  • Pregnancy (i.e. known pregnancy or positive pregnancy test)
  • Breastfeeding

Inclusion Criteria

  • Locally Advanced or Metastatic non-small cell lung cancer with a RET gene fusion
  • Advanced or Metastatic Medullary Thyroid Cancer (MTC) with a RET mutation requiring systemic therapy
  • Advanced or Metastatic Thyroid Cancer with a RET gene fusion requiring systemic therapy who are radioactive iodine-refractory (if radioactive iodine is appropriate)
  • Advanced or Metastatic solid tumors with a RET gene fusion that progressed on or following prior therapy or who have no satisfactory alternative treatment options

Additional Inclusion Criteria

  • Care is provided by a VA/VA purchased care oncology provider
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Goals of care and role of Palliative Care consult have been discussed and documented

Pregnancy Counseling Requirement

  • For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 week after stopping treatment

Source Documents