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Pomalidomide, sold under the brand name Pomalyst among others, is an anti-cancer medication used for the treatment of multiple myeloma and AIDS-related Kaposi sarcoma. It inhibits angiogenesis, the formation of new blood vessels.
Read the full article on WikipediaMultiple myeloma Clinical criteria: Treatment Phase: Initial treatment - dual therapy in combination with dexamethasone The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone, AND Patient must have undergone or be ineligible for a primary stem cell transplant, AND Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information, AND Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information. Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and (2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
“Pomalidomide directly inhibits angiogenesis and myeloma cell growth. This dual effect is central to its activity in myeloma, rather than other pathways such as TNF alpha inhibition, since potent TNF inhibitors including rolipram and pentoxifylline do not inhibit myeloma cell growth or angiogenesis.”
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