Tibsovo®
Drug - Tibsovo® (ivosidenib) [Agios Pharmaceuticals, Inc.]
June 2019
Therapeutic area - Oncology, Oral
Initial approval criteria
- Patient must be at least 18 years of age AND
- A confirmed diagnosis of ONE of the following:
- Relapsed or refractory acute myeloid leukemia (AML) OR
- A condition listed in the FDA-approved label AND
- ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate:
- A susceptible IDH1 mutation in the blood or bone marrow as detected by an FDA-approved test
- Complete blood count with differential
- Comprehensive metabolic panel
- EKG AND
- Patient does NOT have any of the following:
- Severe renal impairment (eGFR < 30mL/min//1.73m2) OR
- Renal impairment requiring dialysis OR
- Moderate to severe hepatic impairment (total bilirubin ≥ 1.5X ULN and any value for AST) AND
- Documentation that the prescriber has conducted a comprehensive review of all of patient’s current medications to ensure no significant drug interaction exists or dose modification if appropriate with:
- Strong or moderate CYP3A4 inhibitors
- Strong CYP3A4 inducers
- Sensitive CYP3A4 substrates
- QTc prolonging drugs
- Initial approval is for 6 months
Renewal criteria
- Patient continues to meet the initial approval criteria AND
- Patient has no evidence of disease progression as determined by prescriber AND
- Patient does not have any unacceptable toxicity from the drug (e.g., development of Guillain-Barre syndrome, QTc prolongation with signs and symptoms of life-threatening arrhythmia, etc.)
- Renewal approval is for 12 months
Quantity limits
Questions?
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