Vintafolide 属于长春花类生物碱类似物，由叶酸和细胞毒药物去乙酰基长春碱单酰肼(DAVLBH)组成。叶酸成分使DAVLBH优先作用于表达叶酸受体的肿瘤细胞，通过抑制微管组装和细胞分裂而起作用。

        Vintafolide与多柔比星脂质体(PLD)联合应用较单用PLD可改善铂类抵抗卵巢癌患者的PFS。常见的副作用为乏力、口炎、中性粒细胞减少、贫血、恶心、手足综合征、便秘、皮疹和外周感觉神经炎。Vintafolide获批的适应证为“与PLD联合用于治疗所有靶病变表达叶酸受体的铂类耐药成年卵巢癌患者。

        同一天，人用医药产品委员会(CHMP)还建议批准医用产品Folcepri(etarfolatide，一种靶向叶酸的分子显像剂)和Neocepri(叶酸)上市，作为伴随诊断检测产品，应用单光子发射体层摄影(SPECT)、CT 或磁共振成像(MRI)成像，了解叶酸受体状态，以选择适合应用vintafolide的患者。

        Folcepri 和Neocepri 在2012 年9 月10日被授予孤儿医用产品称号，Folcepri活性成分etarfolatide由叶酸和99Tc螯合肽组成，与很多肿瘤包括卵巢癌表面表达的叶酸受体结合。以99Tc放射标记后，用于SPECT成像，以检测表达叶酸受体的肿瘤细胞。Folcepri的副作用为瘙痒，并不常见。Neocepri 活性成份为叶酸，在99Tc-etarfolatide SPECT成像前注射，可以减少多数正常非靶组织如小肠、肝、肾、脾的非特异背景，提高成像质量。

On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Vynfinit, intended for the treatment of adult patients with platinum-resistant ovarian cancer who express the folate receptor on all target lesions. Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, such as Folcepri (see Summary of Opinion on Folcepri).

Vynfinit was designated an orphan medicinal product on 9 February 2012. The applicant for this medicinal product is Endocyte Europe, B.V.

Vynfinit is to be available as a 2.5 mg powder for solution for injection. The active substance of Vynfinit is vintafolide, which belongs to the therapeutic group ‘vinca alkaloid and analogues’ (L01CA06). Vintafolide consists of folic acid and the cytotoxic agent desacetylvinblastine hydrazide (DAVLBH). The folic acid component enables DAVLBH to be delivered preferentially to cancer cells expressing folate receptors. Once delivered inside cancer cells, DAVLBH is released from vintafolide and acts by inhibiting microtubule assembly and arresting cells in mitosis.

The benefits with Vynfinit are its ability, in combination with pegylated liposomal doxorubicin (PLD), to improve progression-free survival in patients with platinum-resistant ovarian cancer when compared with treatment with PLD alone. The most common side effects are fatigue, stomatitis, neutropenia, anaemia, nausea, palmar-plantar erythrodysaesthesia, constipation, rash and peripheral sensory neuropathy.

A pharmacovigilance plan for Vynfinit will be implemented as part of the marketing authorisation.

The text for the approved indication is as follows: "Vynfinit in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of adult patients with platinum resistant ovarian cancer (PROC) who express the folate receptor (FR) on all target lesions. Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, using single photon emission computed tomography (SPECT) imaging, in combination with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)". Vynfinit is to be prescribed by physicians experienced in chemotherapy treatment.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.     

详细的说明在   http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002571/WC500163558.pdf