ZURICH (Reuters) Jul 25 - Novartis's cancer treatment Tasigna has received approval in Switzerland, its first certification worldwide, the Swiss drugmaker said on Wednesday.
本月25日（周三），瑞士诺华公司的新型抗肿瘤药物Tasigna已首先获得瑞士药物管理局批准。
"The approval of Tasigna came after an accelerated review by the Swiss health authority Swissmedic based on positive findings from a pivotal phase II trial," Novartis said.
据该公司称，由于在二期临床研究阶段治疗作用效果良好，药管部门加快审评速度，Tasigna得以批准。
Last week the company said U.S. regulators had extended the review period for Tasigna by three months to analyse additional data.
诺华公司称，上周FDA将审评时限延长3个月，以便进一步分析该药研究数据和资料
Novartis said on Wednesday that it expected decisions on Tasigna in the United States and Europe in 2007 and it had filed the drug for submission in Japan in the second quarter 2007.
诺华公司周三称，2007年该药有望在美国和欧洲获批，同时在下半年他们已经完成向日本提交该药的注册申请资料。
More phase III studies involving Tasigna and patients with chronic myeloid leukemia were planned for 2007, Novartis said.
诺华公司称，2007年他们将继续进行慢性粒细胞性白血病／骨髓性白血病治疗的III 期临床研究
"A registration study is already underway in patients with gastrointestinal stromal tumors (GIST), which can also be treated with Glivec in certain countries," the company said.
诺华公司还称，另外一项对于胃肠肿瘤患者的疗效的注册研究正在进行中，一些国家也用Glivec治疗此类肿瘤疾病。
本月25日（周三），瑞士诺华公司的新型抗肿瘤药物Tasigna已首先获得瑞士药物管理局批准。
"The approval of Tasigna came after an accelerated review by the Swiss health authority Swissmedic based on positive findings from a pivotal phase II trial," Novartis said.
据该公司称，由于在二期临床研究阶段治疗作用效果良好，药管部门加快审评速度，Tasigna得以批准。
Last week the company said U.S. regulators had extended the review period for Tasigna by three months to analyse additional data.
诺华公司称，上周FDA将审评时限延长3个月，以便进一步分析该药研究数据和资料
Novartis said on Wednesday that it expected decisions on Tasigna in the United States and Europe in 2007 and it had filed the drug for submission in Japan in the second quarter 2007.
诺华公司周三称，2007年该药有望在美国和欧洲获批，同时在下半年他们已经完成向日本提交该药的注册申请资料。
More phase III studies involving Tasigna and patients with chronic myeloid leukemia were planned for 2007, Novartis said.
诺华公司称，2007年他们将继续进行慢性粒细胞性白血病／骨髓性白血病治疗的III 期临床研究
"A registration study is already underway in patients with gastrointestinal stromal tumors (GIST), which can also be treated with Glivec in certain countries," the company said.
诺华公司还称，另外一项对于胃肠肿瘤患者的疗效的注册研究正在进行中，一些国家也用Glivec治疗此类肿瘤疾病。