罗氏基底细胞癌药物Erivedge获欧盟有条件批准

2013年7月15日讯 /生物谷BIOON/ --罗氏（Roche）今日宣布，欧盟委员会（EC）已授予Erivedge（vismodegib）有条件批准（conditional approval），用于不适宜手术或放疗治疗的有症状转移性基底细胞癌（BCC）或局部晚期BCC成人患者的治疗。该项批准，使Erivedge成为欧盟首个获批用于这一严重危机生命的皮肤癌的药物。

有条件批准授予具有积极效益/风险评估的产品，以满足一种严重未获满足的医疗需求，将带来重大的公共卫生利益。根据有条件批准的规定，罗氏将提供目前正在开展的全球安全性研究中有关Erivedge治疗晚期BCC的额外数据。

2012年1月，FDA通过优先审查程序批准了Erivedge，成为美国首个获批用于晚期BCC治疗的药物，专门用于已经不能开刀或化疗治疗的局部晚期基底细胞癌或癌变已扩散至身体其他器官的BCC患者的治疗。自2012年10月，Erivedge已获瑞士、澳大利亚、以色列、韩国、墨西哥、厄瓜多尔批准。目前，罗氏正积极与多国的监管机构密切合作，确保Erivedge能尽快上市。

基底细胞癌是最常见的皮肤癌之一，它源于皮肤表层，患者同时不会感到疼痛。对于经常暴露在阳光下或是紫外线照射的皮肤病发的几率最大。

Erivedge是一种日服的药片，通过抑制Hedgehog 路径来发挥作用，这种路径在大多数基底细胞癌中活性很高。（生物谷Bioon.com）

英文原文：Roche’s Erivedge receives conditional EU approval for treatment of advanced basal cell carcinoma

Erivedge is a new medicine that helps people with a disfiguring and potentially life-threatening form of skin cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This approval makes Erivedge, a capsule taken once-a-day, the first licensed medicine for patients in the European Union with this disfiguring and potentially life-threatening form of skin cancer.

A conditional marketing authorisation is granted to medicinal products with a positive benefit/risk assessment that satisfy an unmet medical need and whose availability would result in a significant public health benefit. Under the provisions of the conditional approval, Roche will provide additional data on Erivedge in advanced BCC from an ongoing global safety study.

“Today’s approval is great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat their disease,” said Hal Barron MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Erivedge substantially reduced tumour size in patients in clinical trials, and we are pleased that Erivedge will now be available to patients in the European Union.”

Basal cell carcinoma is generally considered curable when confined to the skin. However, in some cases the disease will invade surrounding tissue (locally advanced) or spread to other parts of the body (metastatic BCC) in a manner that cannot be effectively treated with surgery or radiation.

In January 2012, Erivedge became the first licensed medicine for patients with advanced BCC in the United States when the U.S. Food and Drug Administration (FDA) approved it under the priority review programme that provides for an expedited review of drugs that offer major advances in treatment. Since October 2012, Erivedge has been approved in Switzerland, Australia, Israel, South Korea, Mexico and Ecuador.  Roche is working closely with other regulatory authorities to ensure Erivedge is made available as quickly as possible.

About the ERIVANCE BCC study

This conditional approval is based on findings from the primary analysis (26 November 2010) in the pivotal ERIVANCE BCC phase II single-arm study which enrolled 104 patients with advanced BCC (71 had locally advanced and 33 had metastatic disease) from 31 study sites in the U.S., Australia and Europe.1

The study showed Erivedge substantially shrank lesions (objective response rate, or ORR) in 43 percent (27/63) of patients with locally advanced BCC and 30 percent of patients (10/33) with metastatic BCC, as assessed by independent review. The median duration of response was 7.6 months.

The most common adverse events included muscle spasms, hair loss, altered taste sensation, fatigue and weight loss. Serious adverse events (SAEs) were observed in 26 patients (25 percent), however of these only four (4 percent) patients had SAEs that were considered to be related to treatment with Erivedge.

About the STEVIE study

The safety profile of Erivedge is being further assessed in STEVIE, a global, single-arm, open-label multicentre study of patients with advanced forms of basal cell carcinoma. The study aims to enrol 1,200 patients. An interim analysis from STEVIE presented at ASCO 2013 confirmed a similar safety profile to that observed in the ERIVANCE BCC study.2

(责任编辑：lili.zhao)