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DrugStivarga (regorafenib) [Bayer HealthCare Pharmaceuticals Inc.]

February 2013

Therapeutic Area - Oral Oncology

Approval criteria

  • Diagnosis of metastatic colorectal cancer AND
  • Tried and failed fluoropyrimidine, oxaliplatin and ironotecan-based chemotherapy AND
  • Tried and failed bevacizumab OR panitumumab OR cetuximab


  • Diagnosis of gastrointestinal stromal tumor AND
  • Tried and failed imatinib AND
  • Tried and failed sunitinib

Quantity limits

  • The initial PA will allow a first fill of 14 days [56 tablets] with one refill to ensure patient tolerance with therapy before approving in larger, monthly quantities
  • Monthly quantity limit = 84

Background information

Stivarga is a kinase inhibitor indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.  NCCN Colon Cancer Guidelines Version 3.2013 indicates that regorafenib is a treatment option after first, second, or third progression, depending on previous lines of therapy.  Best supportive care and clinical trial is also listed as an alternate option to regorafenib.


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

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