Alunbrig
Drug - AlunbrigTM (brigatinib) [Takeda Oncology]
January 2018
Therapeutic area - Oral Oncology
Approval criteria
- Patient must be at least 18 years of age AND
- Patient must have a diagnosis of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) AND
- Patient must have disease progression or are intolerant to crizotinib AND
- Prescriber must attest that patient will receive reproductive health counseling during treatment with Alunbrig and for at least 4 months following the final dose AND
- Patient must not have any one of the following:
- Moderate to severe hepatic impairment
- Severe renal impairment
Renewal criteria
- Documentation must be supplied at time of request showing patient has no disease progression AND
- Patient must not have any one of the following:
- Moderate to severe hepatic impairment
- Severe renal impairment AND
- Absence of any unacceptable toxicities from the drug, including:
- Grade 3 or 4 pneumonitis or recurrent Grade 1 or 2 pneumonitis
- Grade 4 or recurrent Grade 3 hypertension
- Life-threatening bradycardia if no contributing concomitant medication is identified
- Grade 4 visual disturbances
Quantity limits
68 tablets per 34 days
Background
Alunbrig is FDA-approved under accelerated approval based on tumor 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.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
