Fruzaqla (fruquintinib)

FRUZAQLA (fruquintinib)

Self-Administration – oral capsules

Diagnosis considered for coverage:

Metastatic colorectal cancer (mCRC): Indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, an anti VEGF therapy, and, if RAS wild type and medically appropriate, an anti-EGFR therapy

Coverage Criteria:

For diagnosis of Metastatic Colorectal Cancer (mCRC):

• Diagnosis of metastatic colorectal cancer (mCRC) AND
• Patient has been previously treated with both of the following:
  • Fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy (e.g., FOLFOX, FOLFIRI, FOLFOXIRI) AND
  • Anti-VEGF biological therapy (e.g., Avastin [bevacizumab], Zaltrap [ziv-aflibercept]) AND
• One of the following:
  • Patient has RAS mutant tumors OR
  • Both of the following: 
    • Patient has RAS wild-type tumors 
    • Patient has been previously treated with both of the following:
      • An anti-EGFR biological therapy (e.g., Vectibix [panitumumab], Erbitux [cetuximab]) AND
      • One of the following: 
        • Lonsurf [trifluridine/tipiracil]
        • Stivarga [regorafenib]

Reauthorization Criteria:

For diagnosis of Metastatic Colorectal Cancer (mCRC):

• Patient does not show evidence of progressive disease while on therapy

Dosing: 

For diagnosis of Metastatic Colorectal Cancer (mCRC):

• The recommended dose of fruquintinib is 5 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity
• Fruquintinib should be taken with or without food at approximately the same time daily
• Fruquintinib capsules should be swallowed whole
• A missed dose should be taken if < 12 hours have passed since the missed scheduled dose. An additional dose should not be taken if vomiting occurs after taking fruquintinib
• A dose reduction to 4 mg orally once daily and a second dose reduction to 3 mg once daily (if required) is allowed if the patient is experiencing AEs

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Standard of care for first line treatment of mCRC includer a fluoropyrimidine and either oxaliplatin or irinotecan (or both) ± bevacizumab.
• Second-line treatment: Chemo with a different regimen (eg, FOLFIRI or FOLFOX) or targeted therapies (eg, RAS wild-type would receive anti-EGFR [cetuximab or panitimumab] → if progression, then targeted therapies or Stivarga (regorafenib; VEGF receptor antagonist) or Lonsurf (trifluridine/tipiracil). 
• Fruquintinib, a small molecule kinase inhibitor of VEGF receptor-1, -2, and -3. VEGF receptor signaling is implicated in tumor angiogenesis, growth, and progression in a variety of solid tumors approved in November for use after first-line chemo and anti-VEGF agent.
• Fruzaqla (fruquintinib) is a VEGF receptor inhibitor that was recently approved by the FDA for the treatment of mCRC in patients who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Policy Updates:

• 6/1/2024 (policy effective date)- New Fruzaqla Criteria (P&T 5/20/2024) (P&T Meeting May) 

References:

1. Fruzaqla Prescribing Information. Takeda Pharmaceuticals America, Inc., Lexington, MA. November 2023