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DrugVitrakvi® (larotrectinib) [Bayer HealthCare Pharmaceuticals Inc.]

April 2020

Therapeutic area - Oncology, Oral - Other

Initial approval criteria

  • Patient must be ≥ 28 days of age AND
  • Patient has a solid tumor (e.g., soft tissue sarcoma, salivary gland, infantile fibrosarcoma, thyroid, lung, or gastrointestinal stromal tumors) AND
  • The tumor has a positive NTRK gene fusion status, without a known acquired resistance mutation, as determined by laboratory testing (e.g., next generation sequencing [NGS] or fluorescence in situ hybridization [FISH]) AND
  • Patient’s tumor is metastatic or surgical resection is likely to result in severe morbidity AND
  • Patient has no satisfactory alternative treatments or has progressed following treatment
  • Initial approval is for 3 months

Renewal criteria

  • Patient continues to meet above criteria AND
  • Patient has tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
  • Patient does not have unacceptable toxicity such as severe neurotoxicity, hepatotoxicity; (adverse effects resolve following dose recommendations/no permanent discontinuation required)
  • Renewal approval is for 3 months

Quantity limits

  • Maximum dose of 200 mg/day
  • 25 mg capsule: 90 capsules/30 days
  • 100 mg capsule: 60 capsules/30 days
  • 20 mg/mL oral solution: 300 mL/30 days


Vitrakvi is FDA-approved under 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 confirmatory trials.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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