Initial US Approval

  • 20201

Indications

  • The treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. 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).1
  • For the treatment of adults with relapsed or refractory myeloid/lymphoid
    neoplasms (MLNs) with FGFR1 rearrangement.1

Recommended Dose/Route

  • Pemigatinib, 13.5 mg, orally once daily, with or without food, for 14 consecutive days followed by 7 days off therapy in 21-day cycles.1
Dose Reductions for Adverse Reactions with Pemigatinib

Dose Reductions for Adverse Reactions with Pemigatinib

Pivotal Studies

  • FIGHT-202 (NCT02924376)2
  • Key Inclusion Criteria: A total of 107 patients with locally advanced, unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after at least 1 prior therapy and who had an FGFR2 gene fusion or nonfusion rearrangement as determined by a clinical trial assay performed at a central laboratory.1
  • Treatment: Pemigatinib in 21-day cycles at a dosage of 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy until disease progression or unacceptable toxicity occurred.1
Pemigatinib: Efficacy Data

Pemigatinib: Efficacy Data

Safety

  • Common Adverse Reactions (≥25%): The most frequently reported any grade AEs were hyperphosphatemia (60%), alopecia (49%), diarrhea (47%), nail toxicity (43%), fatigue (42%), nausea (40%), dysgeusia (40%), constipation (35%), stomatitis (35%), dry eye (35%), dry mouth (34%), decreased appetite (33%), vomiting (27%), and arthralgias (25%).1
  • Common Laboratory Abnormalities (≥35%): The most frequently reported laboratory abnormalities were increased phosphate (94%), decreased phosphate (68%), increased alanine transaminase (43%), increased aspartate transaminase (43%), increased calcium (43%), increased alkaline phosphate (41%), increased creatinine (41%), decreased sodium (39%), increased glucose (36%), and decreased lymphocytes (36%).1
  • Dose interruptions due to Adverse Events (AEs): 43%1
  • Dose reductions due to AEs: 14%1
  • Permanent discontinuation due to AEs: 9%1

References

  1. PEMAZYRE (pemigatinib). Prescribing information. Incyte; 2023. Accessed April 10, 2024. https://www.pemazyre.com/pemazyre-prescribing-information
  2. Abou-Alfa GK, Sahai V, Hollebecque A, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21(5):671-684. doi:10.1016/S1470-2045(20)30109-1