Spotlight on talimogene laherparepvec for the treatment of melanoma lesions in the skin and lymph nodes

IF 6.7
M. Orloff
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引用次数: 17

Abstract

On October 27, 2015, talimogene laherparepvec (T-VEC), a first in class intralesional oncolytic virotherapy, was granted the US Food and Drug Administration approval for the treatment of melanoma in the skin and lymph nodes. Its approval has added yet another therapeutic option to the growing list of effective therapies for melanoma. Though the Phase III OPTiM trial has demonstrated its efficacy as a single agent, the target patient population remains narrow. With numerous effective and tolerable treatments available for unresectable and metastatic melanoma, intralesional therapies such as T-VEC are still finding their niche. T-VEC is now widely accepted as option for treatment; however, its combination with various other agents in an effort to expand its use and synergize with other interventions is still being explored. This article will review the pre-clinical and clinical work that eventually led to the Food and Drug Administration approval of this first-in-class agent, as well as address concerns about clinical application and ongoing research.
聚焦于塔里莫gene laherparepvec治疗皮肤和淋巴结黑色素瘤病变
2015年10月27日,talimogene laherparepvec (T-VEC)获得美国食品和药物管理局批准,用于治疗皮肤和淋巴结黑色素瘤。T-VEC是一种同类首创的局内溶瘤病毒疗法。它的批准为黑色素瘤的有效治疗方法增加了另一种治疗选择。尽管OPTiM III期临床试验已经证明了其作为单一药物的疗效,但目标患者群体仍然很狭窄。对于不可切除和转移性黑色素瘤,有许多有效且可耐受的治疗方法,病灶内治疗如T-VEC仍在寻找其利基。T-VEC现在被广泛接受为治疗方案;然而,目前仍在探索其与其他各种药物的结合,以扩大其使用并与其他干预措施协同作用。本文将回顾临床前和临床工作,最终导致美国食品和药物管理局批准这种一流的药物,以及对临床应用和正在进行的研究的关注。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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