Vitrakvi (larotrectinib) is considered medically necessary for patients meeting
the following conditions:
diagnoses with presence of solid tumors that are positive for neurotrophic
receptor tyrosine kinase (NTRK) gene fusion (e.g. ETV6-NTRK3, TPM3-NTRK1,
LMNA-NTRK1, etc.) AND
without a known acquired resistance mutation [e.g. TRKA G595R substitution, TRKA
G667C substitution, or other recurrent kinase domain (solvent front and xDFG)
metastatic or unresectable (including cases where surgical resection is likely
to result in severe morbidity) AND
One of the
progressed on previous treatment (e.g., surgery, radiotherapy, or systemic
no satisfactory alternative treatments.
not shown evidence of progression while on Vitrakvi therapy.