Xpovio

Selinexor

• Brand(s): Xpovio
• Dosage Form/Strength: 20 mg tablet
• Effective date: September 7, 2023

Initial Criteria:

For the treatment of patients with relapsed and/or refractory multiple myeloma who meet ALL of the following criteria:

1. Aged 18 years old or older; AND
2. Patient has failed treatment with at least one prior therapy for multiple myeloma; AND
3. Patient is using selinexor in combination with bortezomib and dexamethasone (SVd) (Note 1); AND
4. Patient is deemed to be sensitive to proteasome inhibitors (PIs) (Note 2), defined as having disease that has not been refractory to bortezomib or another PI, and/or has not experienced disease progression while on bortezomib or another PI (Note 3)

Notes:

1. Patients must meet the eligibility requirements for bortezomib through the New Drug Funding Program (NDFP).
2. Prior proteasome inhibitor (PI) therapy is permitted provided:
   • The patient had a PI treatment-free interval of at least 6 months before the start of SVd; AND
   • Achieved a best response of at least a partial response (PR) with prior bortezomib (at any time), and achieved a best response of at least a PR during the last PI therapy (alone or in combination); AND
   • The patient did not discontinue bortezomib due to grade 3 or higher toxicity.
3. Refractory disease is defined as:
   a. Disease progression within 60 days after stopping treatment; or
   b. Disease progression on any dose of selinexor, bortezomib or another PI; or
   c. Non-responsive disease during therapy (either failure to achieve minimal response or disease progression).

   Relapsed / Disease Progression is defined as having one or more of the following:
   a. An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200 mg/24 hours).
   b. An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved free light chain (FLC) levels (if no measurable serum and urine M-protein levels).
   c. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
   d. Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

4. Patients with plasma cell leukemia or systemic light chain amyloidosis may be considered for funding of Selinexor (as part of SVd) provided all other eligibility criteria are met.

Exclusions:

Patients meeting any of the below criteria will not be eligible for reimbursement of selinexor:

• Patients with multiple myeloma who have experienced disease that has been refractory to treatment with bortezomib or selinexor.
• Patients with multiple myeloma who have experienced disease progression while on bortezomib or selinexor.
• Patients requesting selinexor as part of a first line treatment regimen for multiple myeloma.
• Patients requesting selinexor as monotherapy for multiple myeloma.

Renewal criteria:

Renewal of reimbursement of selinexor for use in combination with bortezomib and dexamethasone may be considered in those who continue to respond to therapy and have not experienced refractory disease, disease progression, or unacceptable toxicity.

Recommended Dose:
Selinexor 100 mg on days 1, 8, 15, 22, and 29 of each 35-day cycle

Bortezomib dosing: 1.3 mg/m² subcutaneously (SC) or intravenously (IV) on days 1, 8, 15, and 22 in combination with selinexor and dexamethasone administered on an every 35-day cycle.

Approval duration of initials and renewals:1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests