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【Revlimid(Lenalidomide)】FDA批準(zhǔn)用于治療骨髓異常綜合癥所致的貧血,適用于多發(fā)性骨髓瘤、惡性血液疾病等。
- 來源： 新特藥房藥訊 作者：百濟(jì)動(dòng)態(tài) 瀏覽： 發(fā)布時(shí)間：2006/7/10 11:27:00
MDS患者體內(nèi)的骨髓未產(chǎn)生足夠的正常血細(xì)胞時(shí)，會(huì)導(dǎo)致身體多方面出現(xiàn)異常。MDS患者可以通過輸血或輸注血小板進(jìn)行治療，同時(shí)使用抗生素以防感染。在臨床試驗(yàn)中，患者使用Revlimid進(jìn)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(huì)導(dǎo)致胎兒畸形的Thalidomide相似。FDA稱，這種藥在銷售時(shí)應(yīng)在標(biāo)簽中應(yīng)加入警示信息，女性患者在使用這種藥之前應(yīng)進(jìn)行懷孕檢測(cè)并征得醫(yī)生同意，開這種藥的醫(yī)生應(yīng)進(jìn)行相應(yīng)登記。目前，相關(guān)人員正在通過動(dòng)物試驗(yàn)確定懷孕期間服用Revlimid是否會(huì)導(dǎo)致胎兒畸形。
Celgene公司近日宣布，revlimid（曾用名：revimid）已被歐洲藥品評(píng)審局(EMEA)定義為罕用藥。Revlimid是新型的免疫調(diào)節(jié)劑，適應(yīng)證范圍廣泛，包括多發(fā)性骨髓瘤、惡性血液疾病（譬如：骨髓增生異常綜合征和轉(zhuǎn)移性黑色素瘤）。
Revlimid作為罕用藥享有EMEA授予的優(yōu)惠措施。一旦revlimid獲批上市，將在多發(fā)性骨髓瘤治療領(lǐng)域享有10年市場(chǎng)獨(dú)占期。EMEA將為revlimid在歐洲的集中申請(qǐng)程序提供便利，減少申請(qǐng)費(fèi)用。
多發(fā)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(rèn)定為罕用藥，進(jìn)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(xì)胞生成障礙性疾病，最終將導(dǎo)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(jīng)接受骨髓干細(xì)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(píng)估，46例患者參加了對(duì)療效的評(píng)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(fā)性骨髓瘤 骨髓綜合癥 Revlimid Lenalidomide
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