OH Epic Formulary, available via treatment plan, restricted to:

• Indication: treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor
• Service line: Hematology/Oncology
• Formulary location: Inpatient
• Service location: Inpatient
• Patient population: Adult
• Prior authorization required: Yes - via Single Case Agreement
• Restriction/criteria of use (all will apply unless specified):
  • Documented diagnosis of unresectable or metastatic melanoma (stage IIIC or stage IV)
  • Documented radiologic disease progression and must have progressed following ≥1 prior systemic therapy including a PD-1-blocking antibody, and if BRAF V600 mutation-positive, a BRAF or BRAF/MEK inhibitor
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • An estimated life expectancy of ≥ 3 months
  • Ejection fraction must measure greater than or equal to 45%
  • Forced expiratory volume must be greater than 60% in 1 second
  • No prior organ allograft, cell transfer therapy, or chronic systemic steroid use
  • No symptomatic and/or untreated brain metastases
  • Adequate organ function:
    • Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN
    • Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula
    • Total bilirubin ≤ 2 mg/dL
    • Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL
  • At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post- resection to generate tumor infiltrating lymphocyte (TIL) therapy and at least 1 remaining measurable target lesion.
  • Only administered at a tumor infiltrating lymphocyte (TIL) treatment center certified by Iovance Biotherapeutics Inc.             

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