Pemazyre™
Drug - Pemazyre™ (pemigatinib) [Incyte Corporation]
September 2020
Therapeutic area - Oncology Agents, Oral
Initial approval criteria
- Patient is ≥ 18 years of age AND
- Patient has a diagnosis of cholangiocarcinoma AND
- Patient has unresectable locally advanced or metastatic disease AND
- Patient has a susceptible gene mutation rearrangement or fusion in the fibroblast growth factor receptor 2 (FGFR2) gene, as determined by an FDA-approved or CLIA-compliant test AND
- Pemigatinib use is subsequent to at least 1 systemic therapy AND
- Pemigatinib will be used as a single agent AND
- Patient has received ophthalmological examinations (e.g., assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography) at baseline and periodically throughout therapy AND
- Patient serum phosphate level is measured at baseline and periodically throughout therapy AND
- Therapy will not be used concomitantly with other selective FGFR-inhibitors (e.g., erdafitinib) AND
- Patient will not be on concomitant therapy with any of the following:
- Strong and moderate CYP3A-Inducers (e.g., rifampin, carbamazepine, St. John’s wort) OR
- Strong or moderate CYP3A4 inhibitors (e.g., fluconazole, itraconazole), if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications
- Initial approval is for 6 months
Renewal criteria
- Patient must continue to meet the above criteria AND
- Disease response with treatment defined by stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED), severe hyperphosphatemia, etc. AND
- Patient’s serum phosphate level is < 7 mg/dL
- Renewal approval is for 6 months
Quantity limits
Maximum dose of 13.5 mg once daily for 14 days of each 21-day cycle
4.5 mg tablet: 14 tablets/21-day cycle
9 mg tablet: 14 tablets/21-day cycle
13.5 mg tablet: 14 tablets/21-day cycle
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
