Lartruvo
Drug - Lartruvo™ (olaratumab) [Eli Lilly]
June 2017
Therapeutic area - Oncology
Approval criteria
- Patient must be 18 years of page or older AND
- Patient has a diagnosis of soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate AND
- Radiotherapy or surgery is not a treatment option AND
- Must use in combination with doxorubicin for the first 8 cycles AND
- Patient’s current ECOG (Eastern Cooperative Oncology Group) performance status is 0 to 2 AND
- At time of request, provider must attest that reproductive health counseling is provided to patients and their partners of child bearing age
- Initial approval is for 6 months
Renewal criteria
- Absence of unacceptable toxicity including grade 3 or 4 infusion related reactions AND
- Absence of disease progression
- Renewal approval is for 6 months
Quantity limits
- 15 mg/kg on days 1 and 8 of each 21-day cycle
- Patient’s weight must be provided at time of request
Background information
Lartruvo is FDA-approved under accelerated approval pathway. Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
