Roche adapts newer breast 癌 麻薬 in 直面する of Herceptin imitations
By John Miller
ZURICH, Feb 5 (Reuters) - スイスの drugmaker Roche 目的（とする）s to broaden the use of its Kadcyla breast 癌 治療 as 競争相手s （人が）群がる into the market with biosimilar copies of its older 主要な支え Herceptin.
Roche said on Tuesday it had 適用するd for U.S. Food and 麻薬 行政 是認 for Kadcyla, a five-year-old 麻薬, for 地位，任命する-surgical use in women with a form of 早期に 行う／開催する／段階 breast 癌 who still show 調印するs of 病気 after 治療 with Herceptin and chemotherapy.
Kadcyla, which 生成するd sales of 979 million スイスの フランs ($981 million) last year, is already 認可するd for people with metastatic HER2-肯定的な breast 癌.
拡大するing use of Kadcyla, which 作品 by 大（公）使館員ing Herceptin to a chemotherapy 麻薬 developed by ImmunoGen Inc to 干渉する with 癌 独房 growth, could help Roche defend its turf in 扱う／治療するing women whose 癌 含む／封じ込めるs 増加するd 量s of a protein known as HER2.
Herceptin is Roche's biggest-selling 麻薬, at about $7 billion last year, but its 特許 has 満了する／死ぬd and its European sales last year 宙返り／暴落するd 16 パーセント. The company sees possible U.S. 競争 in the second half of 2019 from 競争相手s 含むing Celltrion and Teva, Pfizer and Mylan.
"We are working closely with the FDA to bring Kadcyla to people with HER2-肯定的な 早期に breast 癌 who have residual 病気 after neoadjuvant therapy as 早期に as possible," Sandra Horning, Roche´s 長，指導者 医療の officer, said.
是認 of Kadcyla for such 患者s would help Roche 安全な・保証する a big 株 of Herceptin sales now made to 患者s に引き続いて 外科, an 分析家 said.
"With Kadcyla, the だいたい 60 パーセント 株 of sales 生成するd by Herceptin as an adjuvant would be 安全な・保証するd for several years," wrote Michael Nawrath, of Zuercher Kantonalbank, in a 公式文書，認める.
"This prospect is an underrated 資産 in the market," Nawrath said.
Roche 株 were up 0.5 パーセント after the 告示, in line with the rise o f the Stoxx Europe 600 Health Care 索引.
Of people 扱う／治療するd with Kadcyla, 88.3 パーセント did not see their breast 癌 return after three years - compared to 77 パーセント 扱う／治療するd after 外科 with Herceptin - によれば a 臨床の 熟考する／考慮する Roche is using to underpin its 是認 事例／患者 with the FDA.
The FDA has 認めるd the 薬／医学 a 迅速な review, Roche said, pointing to a 決定／判定勝ち（する） in coming months. ($1 = 0.9983 スイスの フランs) (報告（する）／憶測ing by John Miller; Editing by Michael 保護物，者s and Susan Fenton)
