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拜耳Xofigo获FDA批准用于CRPC

  1. Xofigo
  2. 前列腺癌
  3. 拜耳

来源:生物谷 2013-05-17 09:30

2013年5月16日讯 /生物谷BIOON/ --拜耳(Bayer)今天宣布,FDA已批准Xofigo(radium 223 dichloride,镭223二氯)用于有症状骨转移(symptomatic bone metastases )及无已知内脏转移(no known visceral metastatic disease)的阉割性前列腺癌(CRPC)患者的治疗。

2013年5月16日讯 /生物谷BIOON/ --拜耳(Bayer)今天宣布,FDA已批准Xofigo(radium 223 dichloride,镭223二氯)用于有症状骨转移(symptomatic bone metastases )及无已知内脏转移(no known visceral metastatic disease)的阉割性前列腺癌(CRPC)患者的治疗。

Xofigo的优先审查资格日期为2013年8月14日,但FDA提前3个月完成了审查。

Xofigo是获FDA批准的首个α-粒子辐射放射性治疗药物。在关键性III期ALSYMPCA临床试验中,与安慰剂相比,Xofigo显着改善了整体存活率(OS),同时延迟了首次有症状骨骼事件(SSE)的发生时间。

拜耳称,Xofigo的商业化生产目前正在进行中,首批药物预计将在近几周上市。拜耳拥有Xofigo的全球独家销售权。在美国,拜耳与Algeta US公司共同推广该药。

临床试验中,Xofigo表现出了良好的安全性,该药以一种完全新颖的方式改善患者的预后。镭233发射的α粒子能够作用于骨转移的癌细胞,能够帮助改善患者的生存。

Xofigo是继前列腺癌药物Xtandi之后不到一年时间里获FDA批准的又一药物。去年8月,FDA批准Xtandi用于已扩散或复发的晚期(转移性)阉割性前列腺癌男性患者的治疗,该药由安斯泰来(Astellas)和Medivation制药共同销售。

骨骼是体内转移性癌症影响的最常见部位,前列腺癌的骨转移尤其普遍。转移性前列腺癌中有约90%的患者发生骨转移。骨转移能够导致增加骨骼事件的发生频率,并已被证明是CRPC患者发病和致死的主要病因。(生物谷Bioon.com)

英文原文:Bayer Receives U.S. FDA Approval for Cancer Treatment Xofigo (radium 223 dichloride) Injection

New treatment for castration-resistant prostate cancer (CRPC) patients with bone metastases / Xofigo shown in a pivotal Phase III trial to significantly improve overall survival

Berlin, May 15, 2013 – Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) approved Xofigo? (radium 223 dichloride) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal Phase III ALSYMPCA trial.

The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. In the U.S., Bayer HealthCare and Algeta US, LLC will co-promote the product.

“Xofigo shows a favorable safety profile and has the potential to improve patient outcomes in a completely novel way. Radium 223 emits alpha particles that affect cancer cells in bone metastases and may contribute to a survival improvement,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “This FDA approval will provide prostate cancer patients and the physicians who care for them with a new and innovative treatment option.”

“Most men with advanced prostate cancer develop bone metastases, which can be life-threatening,” said Oliver Sartor, MD, North American Principal Investigator for the pivotal trial and medical director of the Tulane Cancer Center. “Xofigo has demonstrated an anti-tumor effect on bone metastases and an overall survival effect in prostate cancer, making it an important addition to the treatment of CRPC patients.”

Bone is the most common site in the body to be affected by metastatic cancer and bone metastases are particularly prevalent in patients with prostate cancer. Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events and have been shown to be the main cause of morbidity and death in patients with CRPC.

Efficacy and Safety Data Supporting Xofigo Approval

The approval of Xofigo (radium 223 dichloride, radium 223) is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, radium 223 significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with radium 223 plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event (SSE) for patients treated with radium 223 vs. placebo.

An updated analysis, conducted after the study was unblinded, showed a further improvement in overall survival (OS) for patients treated with radium 223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).

The most common adverse reactions (greater than or equal to 10%) in patients receiving radium 223 in the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

About Xofigo? (radium 223 dichloride) Injection

Xofigo? with the active ingredient radium 223 dichloride (radium 223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Radium 223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium 223 is less than 100 micrometers, which may limit damage to the surrounding normal tissue.

Radium 223 is currently not approved by the European Medicines Agency (EMA) or other authorities outside the U.S. Bayer submitted a Marketing Authorization Application to the EMA for radium 223 in December 2012 for the treatment of CRPC patients with bone metastases.

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium 223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize radium 223 globally. Algeta will co-promote radium 223 with Bayer in the U.S.

About the ALSYMPCA Trial

The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study of radium 223 dichloride with best standard of care vs. placebo with best standard of care in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of radium 223 or placebo each separated by an interval of four weeks.

The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases

Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man’s health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

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