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欧盟将开始审核默沙东PD-1抗癌药物

  1. PD-1
  2. 欧盟
  3. 默沙东

来源:生物谷 2014-08-23 22:13

欧盟将开始审核默沙东PD-1抗癌药物

2014年7月11日讯 /生物谷BIOON/ --制药巨头默沙东公司近日宣布公司已经正式向美国医药管理局(EMA)提出申请审核公司开发的PD-1抗癌药物pembrolizumab(MK-3475)。公司希望这一药物疗法能被用于治疗黑色素瘤。目前EMA已经接受申请。MK-3475能够刺激患者体内T细胞以激活免疫系统靶向杀灭癌细胞。目前美国FDA也已经接受了默沙东的类似申请。

近年来,由于其优异的疗效,PD-1药物研究领域日趋白热化,施贵宝、罗氏以及阿斯利康等公司都拥有自己的主打产品。分析人士估计这一领域的市场空间将可能达到350亿美元之多。因此可以预见未来这一领域的竞争将更加激烈。(生物谷Bioon.com)

详细英文报道:

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.

"With the five-year survival rate for patients with advanced melanoma at less than 20 percent, there remains a need to offer patients additional options," said Dr. Roy Baynes, senior vice president, clinical development, Merck Research Laboratories. "We are pleased to have regulatory applications under review in the United States and Europe as we work toward bringing pembrolizumab to patients around the world."

About Advanced Melanoma

Melanoma is the most serious form of skin cancer and is the 19th most common cause of cancer death in Europe. In 2012, there were an estimated 22,200 deaths from malignant melanoma in Europe. There were an estimated 232,000 new cases of melanoma diagnosed worldwide in 2012.

About Pembrolizumab

Pembrolizumab (MK-3475) is an investigational, selective, humanized, monoclonal anti-PD-1 antibody designed to reactivate anti-tumor immunity. Pembrolizumab exerts dual ligand blockade of the PD-1 pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2.

Today, pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. For information about Merck's oncology clinical studies, please visit http://www.merck.com/clinical-trials/index.html.

The Biologics License Application (BLA) for pembrolizumab is under priority review with the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced melanoma previously-treated with ipilimumab; the PDUFA date is October 28, 2014. Pembrolizumab has been granted FDA's Breakthrough Therapy designation for advanced melanoma. If approved by the FDA, pembrolizumab has the potential to be the first anti-PD-1 therapy approved within the United States.

About MSD Oncology

At MSD Oncology, our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. Harnessing immune mechanisms to fight cancer is the priority focus of our oncology research and development program. The Company is advancing a pipeline of immunotherapy candidates and combination regimens. Cancer is one of the world's most urgent unmet medical needs. Helping to empower people to fight cancer is our passion. For information about MSD's commitment to Oncology visit the Oncology Information Center athttp://www.mercknewsroom.com/oncology-infocenter.

About MSD

Today's MSD is a global healthcare leader who is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we collaborate with human and animal health professionals across the UK and in more than 140 countries to deliver innovative health solutions. Beyond this, we have a commitment to increasing access to healthcare through far-reaching programmes that donate and deliver our products to people who need them. For more information, please go to www.msd-uk.co.uk.

MSD Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of MSD's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; MSD's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in MSD's/Merck's 2013 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

 

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