Sandoz Pomalidomide

Patient has failed treatment on a lenalidomide-based regimen administered either alone or in combination in any prior line of treatment (Note 1); AND 

Patient has failed treatment on a proteasome inhibitor-based regimen (e.g., bortezomib, carfilzomib) administered either alone or in combination in any prior line of treatment (Note 1); AND 

Patient is deemed to be pomalidomide sensitive, defined as having disease that has not been refractory to a pomalidomide-based regimen, and/or has not experienced progression while on a pomalidomide-based regimen (Note 2); AND

Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone;
OR
b) As a triple therapy regimen in combination with isatuximab and dexamethasone after two prior lines of therapy in a patient who has not been refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab, isatuximab) used in another prior line of treatment (Note 3).

AND 

Patients must have been refractory to the last line of therapy; AND 

Patient has good performance. 

Patient must be lenalidomide resistant AND bortezomib resistant or if they are not bortezomib resistant, they must have experienced disease progression on another proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or has unacceptable toxicities to lenalidomide and/or bortezomib, please include details in your request application for case-by-case consideration. 

Refractory disease is defined as:
a) Disease progression within 60 days after stopping treatment OR
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while on maintenance therapy OR
c) Non-responsive disease during therapy (either failure to achieve minimal response or disease progression).

Relapsed / Progressive disease 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 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.