FDA Grants Priority Review Designation for the Supplemental New Drug Application for Taxotere (docetaxel) for the Treatment of Patients with Advanced Gastric Cancer Hong Kong 16 December 2005 The sanofi-aventis Group recently announced that the U.S Food and Drug Administration has accepted for filing the company s supplemental new drug application for Taxotere (docetaxel) Injection Concentrate in combination with a current standard treatment (cisplatin and 5-fluorouracil) for advanced gastric cancer, also known as stomach cancer. The Priority Review designation means that the FDA will target an agency action on or before March 25, 2006. The supplemental application is based on data from a large Phase III international study, TAX 325, involving 457 patients with advanced gastric cancer. Patients treated with a Taxotere -based chemotherapy regimen (docetaxel, cisplatin and 5-fluorouracil) had a significantly improved overall survival compared to patients who received a standard treatment of cisplatin and 5- fluorouracil (9.2 months vs. 8.6months median survival) with a relative risk reduction in mortality of 23% (log rank p=0.02) and a 2-year survival of 18% versus 9% in favor of the Taxotere arm. In Europe this supplemental application is already under examination by the EMEA on the basis of the TAX 325 study results. A Priority Review designation is assigned by the FDA for those applications that have the potential for providing a significant therapeutic advance. A similar application, based on TAX 325, has also been submitted to and being reviewed by the European Medicines Agency (EMEA). Doctors treating patients with gastric cancer urgently need new and more effective therapeutic strategies and better treatment options to help patients with this devastating disease, said Jaffer A. Ajani, MD, Professor, GI Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston,Texas, principal US investigator of the TAX 325 study. If approved, the incorporation of Taxotere into a commonly used chemotherapy regimen may be the most important development in the treatment of advanced gastric cancer in more than a decade. About Taxotere A growth driver for sanofi-aventis, TAXOTERE (docetaxel) is the foundation of the company s oncology franchise. It is indicated for the breast cancer, lung cancer, prostate cancer, ovarian cancer, head and neck cancer and so forth. In Hong Kong, Taxotere was approved for locally advanced or metastatic breast cancer in 1996, and obtained approval for locally advanced or metastatic non-small-cell lung cancer (NSCLC) and metastatic ovarian cancer in 2000. 1
In 2005, Taxotere was approved for adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer and androgen-independent (hormone-refractory) metastatic prostate cancer. Besides, Taxotere is being studied extensively in clinical trials for safety and efficacy in other solid tumors. Taxotere is a drug that inhibits cell division by essentially freezing the cell s internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere promotes their assembly and blocks their disassembly, thereby preventing many cells from dividing and resulting in cell death. Taxotere is being recognized as one for the most effective chemotherapies. ***** Media contact : Ms Venus Tsang, Communications Manager (852) 2506 8455 About the TAX 325 Study Locally advanced or metastatic gastric cancer (MGC) has a poor prognosis with 2-year survival of only 11.5 percent. This study was undertaken to evaluate the benefits of adding Taxotere to a standard chemotherapy regimen. The primary study endpoint was time to tumor progression (TTP), which was significantly improved with Taxotere based therapy (5.6 months) compared to standard treatment (3.7 months) with a 32% reduction in the risk of progression (log rank p=0.0004). The main secondary endpoint was to detect a statistically significant increase in overall survival. Response rate, time to treatment failure, duration of response, safety profiles, Quality of life and disease related symptoms were collected and evaluated as secondary objectives as well. The Taxotere combination resulted in an increased incidence of diarrhea (19% vs 8%) and low white blood cell counts (82% vs. 57%) which was complicated by fever or infection in 29 vs 12% of cases. Prophylactic use of G-CSF was not recommended in this study. In total, 81.4% of the patients experienced at least one grade3/4 side effect with the Taxotere based regimen versus 75.4% in the control arm. And, there was a 57 percent reduction in Grade 3-4 neutropenia in patients who received G-CSF In this sick patient population, the tolerability of cytotoxic regimens is limited. However, Taxotere combined with cisplatin plus 5FU (TCF) along with appropriate risk management shows promise in the treatment of advanced stomach cancer, said Professor Eric Van Cutsen from the University Hospital of Gasthuisberg, Leuven, Belgium, principal European investigator of the TAX325 trial. These results were presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2005. G-CSF is a drug for increasing white cell count. 2
About Gastric Cancer Gastric cancer ranks the seventh most common cancer in Hong Kong, and the second most common cause of cancer death worldwide. At diagnosis, most patients with gastric cancer have advanced disease with an expected survival of only six to nine months. According to the Hong Kong Cancer Registry, 1,057 new cases were registered in 2002, among them 620 patients were reported dead. Internationally, there are approximately 870,000 new cases every year, claiming the lives of 650,000 people worldwide. About sanofi-aventis Sanofi-aventis is the world s 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY) 3
美國食品及藥物管理局就特素療 ( 多西紫杉醇 ) 用作治療晚期胃癌患者之申請頒發優先考慮 香港,2005 年 12 月 15 日 法國賽諾菲安萬特集團公佈美國食品及藥物管理局已接受集團申請, 考慮讓其抗癌藥特素療 ( 成分名稱 多西紫杉醇 ) 濃縮針劑, 配合目前的標準治療組合 順鉑 (cisplatin) 及 5- 氟尿嘧啶 (5-fluorouracil), 用於治療晚期胃癌病人 有關公佈表示食品及藥物管理局將給該申請頒發優先考慮, 並最快可於 2006 年 3 月 25 日或之前作出決定 特素療 此項申請主要源於一項名為 TAX325 的第三期國際研究, 該研究共有 457 名晚期胃癌患者參與 研究結果顯示, 接受特素療 為本的化療組合 ( 多西紫杉醇 順鉑及 5- 氟尿嘧啶 ) 之病人, 較使用標準治療方案 ( 順鉑及 5- 氟尿嘧啶 ) 之病人, 在整體存活率方面有明顯的改善, 存活率分別為 9.2 個月及 8.6 個月 接受特素療 化療組合之病人在死亡率方面亦相對減少 23%, 兩年存活率與接受標準治療之病人比較分別為 18% 及 9% 美國食品及藥物管理局會對治療效果有顯著效用的藥物之申請, 頒發優先考慮 而歐洲藥物評鑑局 (EMEA) 正審核此項 TAX325 研究結果之申請 美國德克薩斯州大學安達遜癌症中心腫瘤科教授 TAX325 首席研究員 Jaffer A. Ajani 表示 : 治療胃癌的醫生急切需要更新及有效的治療方案及選擇, 協助病人面對此可怕的疾病 此項申請一旦獲得通過, 特素療 將可被廣泛應用於標準化療組合之內, 並成為過去十年在治療晚期胃癌方面, 一項非常重要的發展 特素療 (Taxotere ) 特素療 (Taxotere ) 為集團腫瘤科重要產品之一, 主治乳癌 肺癌 前列腺癌 卵巢 癌 頭頸癌等 有關該藥物在治療其他癌症方面的臨床研究正在進行中 特素療於一九九六年獲香港衛生署批核作治療局部性末期或擴散性乳癌, 於二零零零年獲批核作治療局部性末期或擴散性肺癌和擴散性卵巢癌, 並於二零零五年獲批核作治療早期乳 癌及擴散性前列腺癌 此外, 特素療在其他腫瘤方面亦有大量研究 特素療 (Taxotere ) 屬 Taxane 類化療藥物, 提煉自紫杉木 Taxane 類化療藥透過破壞細胞組織分裂的生長結構 紡錘體的微小管, 阻止癌細胞生長 不少化療藥以影響癌細 胞的 DNA 以阻止癌細胞的分裂, 但特素療則直接破壞細胞分裂的主要結構, 令癌細胞 死亡及腫瘤縮小 特素療獲醫療界認可為現時最有效的抗癌化療藥物之一 ***** 傳媒查詢 : 賽諾菲安萬特傳訊經理曾翠華女士 (852) 2506 8455 4
關於 TAX325 患上晚期或轉移性胃癌之病人, 一般兩年存活率只有 11.5% TAX325 研究特素療 應用於標準化療組合內之治療效果, 首要目的是觀察腫瘤惡化時效 即腫瘤從接受治療至癌症擴散的一段時間 根據 TAX325, 腫瘤惡化時效為 5.6 個月, 相對標準治療的速度 (3.7 個月 ) 緩慢, 減低復發風險率 32%; 研究次目標是觀察病人的整體存活率 另外, 研究亦收集病人對治療的反應率 治療失效時效 反應期 藥物安全 生活質素及與病徵相關的資料 接受特素療 化療組合的病人出現較多肚瀉 (19%vs.8%) 及白血球數量較低 (82%vs. 57%) 的情況, 部份個案會出現發燒或感染 (29% vs. 12%) 而用作預防性增加白血球數量的藥物不在此研究範圍內 總括而言, 接受特素療 組合治療之病人有 81.4% 經歷最少一項 3 或 4 級的副作用, 相較對應組為 75.4% 另外, 預先接受 G-CSF 之病人患上 3 至 4 級白血球減少症的比率下降 57% 來自比利時加斯特保醫院的 TAX325 歐美首席研究員 Eric Van Cutsen 教授表示 : 晚期胃癌患者對化療的耐受性有限, 但特素療 配合順鉑及 5- 氟尿嘧啶使用, 加上適當的疾病管理, 在治療晚期胃癌方面有顯著的效果 有關結果於 2005 年美國臨床腫瘤周年大會上發表 關於胃癌胃癌為香港第七位常見癌病 世界第二位導致死亡的癌病, 一般未期胃癌病人預期存活時間為 6 至 9 個月 根據 2002 年香港癌症資料統計中心數字, 本港每年新增個案 1,057, 共奪去 620 條性命 而全球每年新增個案約為 870,000, 於世界各地奪去 650,000 條性命 關於法國賽諾菲安萬特集團賽諾菲安萬特是全球第三大 歐洲第一大製藥公司 憑著世界水準的科研組織架構, 賽諾菲安萬特在七大醫療範圍取得領導地位 : 心血管 血栓 癌症 代謝失調 中樞神經系統 內科及疫苗 賽諾菲安萬特於巴黎 (EURONEXT: SAN) 及紐約 (NYSE: SNY) 均為上市公司 G-CSF 是提升白血球的藥物 5