MIRVETUXIMAB SORAVTANSINE-GYNX INJ,SOLN

Clinical Criteria Summary

Moderate to severe hepatic impairment defined total bilirubin > 1.5x Upper Limit of Normal (unless Gilbert syndrome with total bilirubin > 3x Upper Limit of Normal)
Severe renal impairment (estimated CrCl 15-30 ml/min)
Active or chronic corneal or ocular conditions requiring ongoing treatment
Peripheral neuropathy > Grade 1
Non-infectious interstitial lung disease, including pneumonitis
Active or uncontrolled infection
Unmanageable drug interaction identified
Known pregnancy
Lactating

Diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
Received at least one prior systemic therapy
Disease considered platinum-resistant
Tumor is folate receptor-alpha (FRα) positive (> 75% viable tumor cells with mod (2+) or strong (3+) staining intensity)
Use of mirvetuximab is as monotherapy or in combination with bevacizumab (or biosimilar)
Care provided by a VA/VA Community Care gynecologic oncology or medical oncology provider
Goals of care and role of Palliative Care consult discussed and documented
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 – 1
Baseline ophthalmology exam including visual acuity and slit lamp exam

For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 7 months after stopping treatment.
For females who are lactating: Breastfeeding/providing breastmilk to an infant is not recommended during therapy and for 1 month after the last dose.

FRα positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in adults
Patients who have received 1-3 prior systemic treatment regimens
High FRα expression defined as > 75% viable tumor cells with moderate (2+) or strong (3+) staining intensity
Patient selection must be based on an FDA-approved test

Intravenous infusion of 6 mg/kg adjusted ideal body weight every 3 weeks until disease progression or unacceptable toxicity
Supplied as a single-dose vial (100mg/20 mL) for dilution and intravenous infusion

Ocular toxicity: Premedicate with lubricating eye drops and topical steroid eye drops
Pneumonitis: Hold therapy for Grade 2 pneumonitis until Grade 1 or lower; discontinue permanently for Grade 3 or 4
Peripheral neuropathy: Withhold, reduce doses, or discontinue depending on severity
Embryo-fetal toxicity: Advise patients of fetal risks; persons of reproductive potential must use effective contraception during treatment and for 7 months after the last dose
Drug interactions: Monitor closely for adverse drug events with strong CYP3A4 inhibitors

Preferred in platinum-refractory or platinum-resistant disease, but only in patients with FRα expression
Category 2B recommendation in NCCN Ovarian Cancer Guidelines (useful in certain circumstances)