礼来单抗新适应症临床III期研究效果良好

仲夏秋夜云

美国礼来于周五宣布，公司旗下单抗药物ramucirumab新适应症的临床III期研究达成预期目标。新适应症为转移性结直肠癌。
　　Ramucirumab是一种完全人源化的血管内皮生长因子(VEGF)单抗。该药物于2014年4月获批，主要用于胃或胃食管交界处(GEJ)腺癌。
　　此次进行的全球范围内、随机、双盲临床III期试验共有超过26个国家的1000位患者参与。结果显示，相比起安慰剂，ramucirumab联合化疗治疗能大幅度改善患者的总体存活率以及无进展生存期。
　　礼来公司表示，将会2015年提交此项研究结果的详细数据并会在2015年上半年向药监局提交申请。

Lilly says with new data, it will seek another approval for Cyramza next year

September 12, 2014 | By Eric Palmer

Eli Lilly ($LLY) has harbored big hopes for its newly approved cancer fighter Cyramza since it picked up the drug in its $6.5 billion deal for ImClone way back in 2008. It expects it to get a string of approvals, and with new data in hand, it said it will go to the FDA with an application for colon cancer in the first half of next year.
Cyramza was approved in April for treating stomach cancer. Today, Lilly said that results from the RAISE study of 1,000 patients who had failed to sufficiently benefit from Roche's ($RHHBY) Avastin and other standard treatments showed a statistical improvement in survival from Cyramza compared with those taking a placebo and chemotherapy.
According to Reuters, the news prompted JPMorgan analyst Chris Schott to tell investors to expect Cyramza sales to reach $1.35 billion in 2020. He said most of that will come from its use in stomach cancer, but approvals for lung cancer and second-line treatment of colorectal cancer will help.
"We now have four Phase III ramucirumab trials that improved survival in three of the world's most common and deadly cancers--gastric, lung, and colorectal--supporting global regulatory submissions in multiple indications," Dr. Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, said today in a statement.
What it doesn't have is a study supporting breast cancer. Last fall, the drug failed a late-stage trial in breast cancer, giving investors pause about its future.
The news today is very important for Lilly, which has had other R&D setbacks. It has been scrambling for a couple of years in anticipation of losing the patent on megablockbuster Cymbalta, which it did late last year. It has cut staff and costs. In its second quarter, Lilly's revenue dropped 17% to $4.9 billion.

幻影

眼馋。

syhorchid

祝贺礼来公司

akiolmx

好消息