Pharmacy Prior Authorization Criteria

Lytgobi (futibatinib)

Indications for Prior Authorization

Lytgobi (futibatinib)

• For diagnosis of Cholangiocarcinoma
  Indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

  This indication is 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 a confirmatory trial(s).

Criteria

Lytgobi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of intrahepatic cholangiocarcinoma
AND
• Disease is one of the following:
• Unresectable
• Locally advanced
• Metastatic
AND
• Disease has presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements [A]
AND
• Patient has been previously treated (e.g., chemotherapy)

Lytgobi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-10-25, 2023-06-05, 2022-11-30

References

1. Lytgobi Prescribing Information. Taiho Oncology, Inc. Princeton, NJ. April 2024.

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End Notes

1. An FDA-approved test for detection of FGFR2 gene fusions or other rearrangements in patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma for selecting patients for treatment with LYTGOBI is not available. The presence of FGFR2 fusions or other rearrangements was determined using next generation sequencing (NGS) testing. [1]

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Revision History

• 2024-10-25: 2024 Annual Review. Background updates only
• 2023-06-05: Removed prescriber requirement.
• 2022-11-30: New Program

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