Imnovid: immunomodulator for multiple myeloma
01 November 2013, 9:35am
Imnovid (pomalidomide) is indicated in combination with dexamethasone for relapsed and refractory multiple myeloma that has progressed in patients who have received at least two prior therapies, including lenalidomide and bortezomib.
Imnovid is given as 4mg once daily on days 1—21 of repeated 28-day cycles, with the dose adjusted according to response
Imnovid is given as 4mg once daily on days 1—21 of repeated 28-day cycles, with the dose adjusted according to response
PHARMACOLOGY
Pomalidomide is an immunomodulator that inhibits proliferation and induces apoptosis of haematopoietic tumour cells. In addition, it has been shown to enhance T cell- and natural killer cell-mediated immunity and to inhibit production of pro-inflammatory cytokines.1,2
CLINICAL STUDIES
In a phase III, open-label study, 455 patients with relapsed and/or refractory myeloma were randomised to receive pomalidomide plus low-dose dexamethasone (n=302) or high-dose dexamethasone alone (n=153).1,2
Patients received either pomalidomide 4mg daily on days 1–21 of each 28-day treatment cycle plus oral dexamethasone 40mg once daily on days 1, 8, 15 and 22 or monotherapy with dexamethasone 40mg once daily on days 1–4, 9–12 and 17–20. Treatment was continued until disease progression or unacceptable toxicity.1,2
Greater survival
Median progression-free survival (the primary efficacy endpoint) was improved by 4 months (95% CI 3.6–4.7) in the pomalidomide plus dexamethasone group compared with 1.9 months in the dexamethasone-only group (HR 0.48, 95% CI 0.39–0.60; p<0.0001).2
The most commonly reported adverse effects were anaemia, neutropenia and thrombocytopenia.1,2
Teratogenic risk
Pomalidomide is structurally related to thalidomide and is therefore expected to be teratogenic. To prevent exposure of pregnant women to pomalidomide, healthcare professionals and patients are required to adhere to the measures specified in the Pregnancy Prevention Programme.1
Pomalidomide Celgene 1 mg Hartkapseln - OP21; Hartkapsel; Celgene Europe Limited
Allgemeine Angaben
Eingangsnummer : 2710621
Arzneimittelname: Pomalidomide Celgene 1 mg Hartkapseln - OP21
Darreichungsform : Hartkapsel
Administrative Daten
Antragsteller: Celgene Europe Limited
Verkehrsfähig : ja
Zulassungs-/Reg-Nr.(AMG76) : EU/1/13/850/001
Zusammensetzung
Arzneilich wirksame Bestandteile
ASK-Nr. Stoffname Stoffmenge
Pomalidomid 1.mg
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ASK-Nr. |
Stoffname |
Stoffmenge |
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Pomalidomid |
1.mg |
Celgene骨髓瘤药物pomalidomide获欧盟委员会批准
赛尔基因（Celgene）8月9日宣布，口服抗癌药物pomalidomide已获欧盟委员会（EC）批准，联合地塞米松（dexamethasone）用于既往已接受过至少2次治疗[包括雷利度胺（ lenalidomide）和硼替佐米（bortezomib）]、且最后一次治疗后经证实病情恶化的复发性和难治性多发性骨髓瘤（rrMM）成人患者的治疗。
在向欧洲药品管理局（EMA）提交更改商品名的通知后，Celgene拟在欧盟以品牌名IMNOVID推出该药。
多发性骨髓瘤（MM）是一种血液癌症，是由于浆细胞（plasma cells）不受控制的复制及在骨髓中的聚集所致。几乎所有的患者都有最终复发（eventual relapse）的风险，这意味着即便获得初步治疗，患者的病情仍可能恶化。
该药的获批，是基于MM-003研究的数据，这是一个多中心、随机、开发标签III期研究，涉及455例患者，该项研究达到了改善无进展生存期（PFS）的主要终点，同时也达到了改善总生存期（OS）的次要终点，PFS和OS的改善均达到了高度统计学显着意义及临床意义。
MM-003研究中，高剂量地塞米松对照组PFS为8.0周，pomalidomide+低剂量地塞米松治疗组PFS为15.7周，具有高度统计学显着差异（15.7周 vs 8.0周，p＜0.001，数据截止2012年9月7日）。高剂量地塞米松对照组OS为34周，pomalidomide+低剂量地塞米松治疗组OS数据尚未得出，同样具有高度统计学显着差异（未得出 vs 34周，p＜0.001）。
今年5月，pomalidomide也获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）建议批准的积极意见。
完整的说明
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002682/WC500147720.pdf
Product details
Name
Imnovid (previously Pomalidomide Celgene)
Agency product number
EMEA/H/C/002682
Active substance
pomalidomide
International non-proprietary name (INN) or common name
pomalidomide
Therapeutic area
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
Additional monitoring
This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.
Treatment of rare diseases
This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.
Publication details
Marketing-authorisation holder
Celgene Europe Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
05/08/2013
Contact address:
Celgene Europe Ltd
1 Longwalk Road
Stockley Park
Uxbridge
UB11 1DB
