Malic acid sunitinib malate is a small molecular compound that can inhibit several tyrosine kinase receptors, and some receptors are relating to growth of tumor, pathological blood vessel growth and cancer transfer, which can interrupt blood and nutrition supply for growth of tumor cells and generate anti-tumor action, in addition, Sutent can also directly kill tumor cells.
Stage III clinic test result has proved that malic acid sunitinib malate can delay tumor development of tumor patients who are durable to the treatment with imatinib，Gleevee, and significantly reduce death rate of patients. It has very high response rate for the patients generating drug-resistant kidney cell cancer, and can effectively postpone development of tumor. Compared with treatment in use of interferon-α, if Sutent is used for late/transfer kidney cell cancer (MRCC) patients, the existence time of patients without worse disease conditions will increase from five months to 11 months. Oral taking of Sutent may bring light or medium adverse reaction such as weakness, nausea, dyspepsia, diarrhea, oral mucositis mucitis, decrease of neutral granulocytes, decrease of blood platelets, dermatitis, hair decoloration, etc., but patients can be able to bear well.
On August 28, 2003, Pfizer of USA first applied international patent for malic acid sunitinib malate (WO 2003／070725) and then Russian patient (RU 2004／124711), Chinese patient (CN1671693), Australian patient (AU 2003／216282), Mexico patient (MXPA 2004／006992) and Canadian patient (CA 2475455), protecting this compound and its synthesis method.
Sutent was first approved for sale in USA market by FDA in January 2006 and sale in British market on July 31, 2006; EU approved malic acid sunitinib malate as a treatment drug of MRCC on January 18, 2007, which is the first drug approved by EU for MRCC, and is also the first new target drug that can selectively aim at several tyrosine kinase receptors. It combines anti-tumor blood vessel formation mechanism and directly anti-tumor mechanism without toxic and side effect of common chemotherapy. By October 1, 2006, the sales amount of this drug hit US$ 115 million, so this new drug, just appearing in the market for one year, was placed close attention. This drug entered Chinese market in the first half of 2008.
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