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【Revlimid(Lenalidomide)】FDA批準用于治療骨髓異常綜合癥所致的貧血,適用于多發性骨髓瘤、惡性血液疾病等。

來源： 新特藥房藥訊 作者：百濟動態 發布時間：2006-7-10 11:27:00
    Celgene公司用于治療由骨髓異常綜合癥（MDS）導致的貧血藥物Lenalidomide通過了FDA的批準。Celgene公司計劃將該藥商品名定為Revlimid。
 
      MDS患者體內的骨髓未產生足夠的正常血細胞時，會導致身體多方面出現異常。MDS患者可以通過輸血或輸注血小板進行治療，同時使用抗生素以防感染。在臨床試驗中，患者使用Revlimid進行平均44周的治療之后，不再需要輸血或輸注血小板。
 
        該藥與會導致胎兒畸形的Thalidomide相似。FDA稱，這種藥在銷售時應在標簽中應加入警示信息，女性患者在使用這種藥之前應進行懷孕檢測并征得醫生同意，開這種藥的醫生應進行相應登記。目前，相關人員正在通過動物試驗確定懷孕期間服用Revlimid是否會導致胎兒畸形。
 
       Celgene公司近日宣布，revlimid（曾用名：revimid）已被歐洲藥品評審局(EMEA)定義為罕用藥。Revlimid是新型的免疫調節劑，適應證范圍廣泛，包括多發性骨髓瘤、惡性血液疾病（譬如：骨髓增生異常綜合征和轉移性黑色素瘤）。
             
        Revlimid作為罕用藥享有EMEA授予的優惠措施。一旦revlimid獲批上市，將在多發性骨髓瘤治療領域享有10年市場獨占期。EMEA將為revlimid在歐洲的集中申請程序提供便利，減少申請費用。
             
        多發性骨髓瘤在常見的血癌中排名第二位，全球影響到15萬人，每年新增患者大約7.4萬。2002年5.7萬人死于該病。2003年，revlimid被FDA認定為罕用藥，進入快速審批通道，用于治療骨髓瘤和骨髓增生異常綜合征。骨髓增生異常綜合征是一種血細胞生成障礙性疾病，最終將導致急性白血病，全球大約30萬人患有該病。
             
        Revlimid的Ⅱ期臨床納入70例患者。患者平均年齡為62歲，有23例已經接受骨髓干細胞移植，23例接受了沙利度胺治療。研究中有57例患者參加了藥物毒性評估，46例患者參加了對療效的評估。
 
 
              FDA Approves New Treatment for Myelodysplastic Syndrome (MDS)
 
              The Food and Drug Administration (FDA) has approved the drug
              Revlimid (lenalidomide) for the treatment of patients with a
              subtype of Myelodysplastic Syndrome (MDS). The subtype is MDS
              patients with deletion 5q cytogenetic abnormality.
 
              MDS is a collection of disorders in which the bone marrow does not
              function normally and the body does not make enough normal blood
              cells. Patients with MDS may need blood and platelet transfusions
              and antibiotic therapy for infections. In clinical trials,
              patients treated with Revlimid no longer needed transfusions, with
              most patients becoming independent of transfusion by three months.
              The transfusion-free period lasted for an average of 44 weeks.
 
              "This new product will offer a much needed treatment option for
              patients suffering from this rare illness that, in some cases, has
              been found to progress to fatal forms of leukemia," said Dr.
              Steven Galson, M.D., Director of FDA''s Center for Drug Evaluation
              and Research (CDER).
              MDS can develop following treatment with drugs or radiation
              therapy for other diseases, or it can develop without any known
              cause. Some forms of MDS can progress to acute myeloid leukemia
              (AML), a type of cancer in which too many white blood cells are
              made.
              An estimated 7,000 to12,000 new cases of MDS are diagnosed yearly
              in the United States. Although MDS occurs in all age groups, the
              highest prevalence is in people over 60 years of age. Typical
              symptoms include weakness, fatigue, infections, easy bruising,
              bleeding, and fever
              Revlimid is structurally similarto thalidomide, a drug known to
              cause severe birth defects. Additional studies are ongoing in
              animals to address whether there is a risk that Revlimid will also
              cause birth defects when taken during pregnancy. While these
              studies are under way, the company is marketing Revlimid under a
              risk management plan called RevAssist, designed to prevent fetal
              exposure.
              Under RevAssist, only pharmacists and prescribers registered with
              the program will prescribe and dispense Revlimid. The program
              requires patients, including female patients undergoing mandatory
              pregnancy testing, to give informed consent before starting
              Revlimid. Physicians are to check pregnancy tests, limit
              prescriptions to a one-month mail supply, and report any
              pregnancies to FDA. FDA and the manufacturer will re-evaluate the
              risk management plan when results of further animal testing for
              birth defects are completed.
              The labeling for Revlimid will include a Black Box Warning and a
              Medication Guide regarding the prevention of fetal exposure.
              Additional Black Box Warnings include the potential need to lower
              the dose due to suppressed blood counts and increased risk of
              blood clots. Common side effects reported with Revlimid include
              thrombocytopenia (low platelet count), neutropenia (low white
              blood cell count), diarrhea, pruritis (itch), rash, and fatigue.
              Revlimid is distributed by Celgene Corporation of Summit, N.J.

TAG： 多發性骨髓瘤 骨髓綜合癥 Revlimid Lenalidomide

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