Folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Active Ingredient: Mirvetuximab soravtansine

Indication for Mirvetuximab soravtansine

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Mirvetuximab soravtansine is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

For this indication, competent medicine agencies globally authorize below treatments:

6 mg/kg adjusted ideal body weight once every 3 weeks until disease progression or unacceptable toxicity

For:

Dosage regimens

Intravenous, 6 milligrams mirvetuximab soravtansine per kilogram of body weight, once every 3 weeks.

Detailed description

The recommended dose is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity.

The total dose of mirvetuximab soravtansine is calculated based on each patient’s AIBW using the following formula:

AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] - IBW)
Female IBW (kg) = 0.9*height(cm) - 92

Premedication and required eye care

Premedication

Administer the premedications in Table 1 prior to each infusion of mirvetuximab soravtansine to reduce the incidence and severity of infusion related reactions (IRRs), nausea, and vomiting.

Table 1. Premedication prior to each mirvetuximab soravtansine infusion:

Premedication Route of administration Examples (or equivalent) Administration time prior to mirvetuximab soravtansine infusion
Corticosteroid intravenous dexamethasone 10 mg At least 30 minutes prior
Antihistamine oral or intravenous diphenhydramine 25 mg to 50 mg
Antipyretic oral or intravenous acetaminophen 325 mg to 650 mg
Antiemetic oral or intravenous 5-HT3 serotonin receptor antagonist or appropriate alternatives Before each dose and thereafter as needed

Consider additional premedications including corticosteroids the day prior to mirvetuximab soravtansine administration for patients who experienced IRRs.

Ophthalmic exams and premedication

Ophthalmic exam: Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of mirvetuximab soravtansine, every other cycle for the first 8 cycles, and as clinically indicated.

Ophthalmic topical steroids: The use of ophthalmic topical steroids is recommended. The initial prescription and renewals of any corticosteroid medication should be made only after examination with a slit lamp. Administer one drop of ophthalmic topical steroids in each eye 6 times daily starting the day prior to each infusion until day 4; then administer one drop in each eye 4 times daily for days 5-8 of each cycle of mirvetuximab soravtansine.

Lubricating eye drops: The use of lubricating eye drops at least four times daily and as needed is recommended during treatment with mirvetuximab soravtansine. Instruct patients to use lubricating eye drops and advise to wait at least 10 minutes after ophthalmic topical steroid administration before instilling lubricating eye drops.

Dosage modifications

Table 2 provides dose reductions and modifications for adverse reactions. Adjust the schedule of administration to maintain a 3-week interval between doses.

Table 2. Dosage Reduction Schedule:

 Mirvetuximab soravtansine dose levels
Starting Dose 6 mg/kg AIBW
First Dose Reduction 5 mg/kg AIBW
Second Dose Reduction 4 mg/kg AIBW*

* Permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.

Table 3. Dosage Modifications for Adverse Reactions:

Adverse Reaction Severity of Adverse Reaction* Dosage Modification
Keratitis/Keratopathy Nonconfluent superficial keratitis Monitor.
Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity Withhold dose until improved or resolved, then maintain at same dose level or consider dose reduction.
Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse Withhold dose until improved or resolved, then reduce by one dose level.
Corneal perforation Permanently discontinue.
Uveitis Grade 1/ Rare cell in anterior chamber Monitor.
Grade 2/ 1-2+ Cell or Flare in anterior chamber Withhold dose until Grade 1 or less, then maintain dose at same dose level.
Grade 3/ 3+ Cell or Flare in anterior chamber Withhold dose until Grade 1 or less, then reduce dose by one dose level.
Grade 4/ Hypopyon Permanently discontinue.
Pneumonitis Grade 1 Monitor.
Grade 2 Withhold dose until Grade 1 or less, then resume at same dose level or one lower dose level at the discretion of the healthcare provider.
Grade 3 or 4 Permanently discontinue.
Peripheral Neuropathy Grade 2 Withhold dose until Grade 1 or less, then reduce by one dose level.
Grade 3 or 4 Permanently discontinue.
Infusion-Related Reactions/Hypersensitivity Grade 1 Maintain infusion rate.
Grade 2 • Interrupt infusion and administer supportive treatment.
• After recovery from symptoms, resume the infusion at 50% of the previous rate, and if no further symptoms appear, increase rate as appropriate until infusion is completed
• Administer additional premedication for future cycles
Grade 3 or 4 • Immediately stop infusion and administer supportive treatment.
• Advise patient to seek emergency treatment and immediately notify their healthcare provider if the infusion-related symptoms recur.
• Permanently discontinue.
Other Adverse Reactions Grade 3 Withhold dose until Grade 1 or less, then resume at one lower dose level.
Grade 4 Permanently discontinue.

* Unless otherwise specified, National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Active ingredient

Mirvetuximab soravtansine

Mirvetuximab soravtansine is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine is internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death.

Read more about Mirvetuximab soravtansine

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