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阿斯利康联手Myriad向胰腺癌个性化治疗发起冲锋

  1. BRCA基因
  2. Lynparza
  3. olaparib
  4. 伴随诊断
  5. 卵巢癌
  6. 阿斯利康

来源:生物谷 2015-04-03 15:29

Lynparza是一种首创PARP抑制剂,已获美欧批准,年销售额有望突破20亿美元。

2015年4月3日讯 /生物谷BIOON/ --阿斯利康(AZN)与美国生物医药企业万基遗传(Myriad Genetics)近日联合宣布,双方将扩大在抗癌药Lynparza(olaparib)方面的合作,将Myriad开发的伴随诊断试剂盒(CDx)用于阿斯利康所关注的各类癌症。此次双方将利用Myriad开发的BRCA Analysis CDx伴随诊断技术,识别可能对抗癌药Lynparza治疗有潜在反应的转移性胰腺癌患者。

Lynparza(olaparib)是阿斯利康研发的一种首创的口服多聚ADP核糖聚合酶(PARP)抑制剂,利用DNA修复途径的缺陷,优先杀死癌细胞。去年圣诞节前夕,Lynparza同时获得美国和欧盟批准,作为一种单药疗法用于铂敏感复发性BRCA胚系突变(gBRCAm)晚期卵巢癌成人患者的维持治疗,成为用于该患者群体的首个PARP抑制剂。

阿斯利康对Lynparza寄予厚望,认为该药的年销售额有望突破20亿美元。为了进一步推进史上首个PARP抑制剂的商业化成功,阿斯利康一直在努力扩大该药的标签,调查用于各种癌症的治疗,包括最致命的胰腺癌。目前,阿斯利康正开展多个III期研究,调查Lynparza用于BRCA突变胰腺癌、卵巢癌、乳腺癌、胃癌的治疗。

阿斯利康表示,与Myriad之间的合作是抗击胰腺癌所迈出的一大步,有望使胰腺癌的个性化治疗成为现实。Myriad开发的BRAC Analysis CDx检测技术有望快速并准确识别出可能从Lynparza治疗中受益的胰腺癌患者群体,并有望促进更好的健康预后。据估计,仅在美国,每年新增4.8万例胰腺癌病例,死亡4.0万例。

Myriad公司的BRAC Analysis CDx于去年12月首次获FDA批准,作为Lynparza的一种伴随诊断,用于卵巢癌患者的临床治疗。BRAC Analysis CDx是一种体外诊断设备,利用全血样本中提取的基因组DNA,识别各种形式的BRCA1和BRCA2基因。

关于BRCA基因:

BRCA1和BRCA2基因属于肿瘤抑制因子编码基因,这些基因的突变,与遗传性乳腺癌和卵巢癌相关。若一个女性继承了BRCA1或BRCA2突变,患乳腺癌和/或卵巢癌的风险将大大增加。在癌细胞扩增至卵巢以外之前,仅有15%的卵巢癌被发现。尽管当前治疗和诊断已经取得了很大进步,但癌细胞已扩散至卵巢外的患者,5年生存率低于50%。

关于Lynparza(olaparib):

Olaparib是一种创新的、潜在首创口服多聚ADP核糖聚合酶(PARP)抑制剂,在临床前模型中已被证明,能够利用DNA修复途径的缺陷,优先杀死癌细胞。这种作用模式,赋予olaparib治疗具有DNA修复缺陷的广泛肿瘤类型的潜力。PARP与广泛的肿瘤类型相关,尤其是乳腺癌和卵巢癌。(生物谷Bioon.com)

英文原文:AstraZeneca plc (ADR) And Myriad Genetics, Inc. Expand Collaboration On Lynparza
Myriad’s BRAC Analysis CDx test will be used to identify prospective patients of metastatic pancreatic cancer who could respond to AstraZeneca’s Lynparza

AstraZeneca plc (ADR) (NYSE:AZN) and Myriad Genetics, Inc. (NASDAQ:MYGN) have announced to expand their companion diagnostic (CDx) collaboration for enhancing focus on various forms of cancer.

As per the terms of the expanded collaboration, the combined companies’ efforts will be used to benefit from the BRAC Analysis CDx test, developed by Utah-based Myriad, for identifying prospective patients of metastatic pancreatic cancer who could potentially respond to treatment with AstraZeneca’s Lynparza.

Lynparza, also known by its chemical name olaparib, works as an orally active PARP (poly-ADP ribose polymerase) inhibitor and targets the deficiencies of DNA repair pathway of various tumors in order to kill tumor cells. Olaparib was first approved by the US Food and Drug Administration (FDA) in December last year, as a first-line monotherapy option for women suffering from deleterious germline BRCA-mutated (gBRCAm) form of advanced ovarian cancer, who had also received three or more prior therapies.

To advance the success of its first ever PARP inhibitor to be approved by the FDA, AstraZeneca has been trying to expand its label for various indications including the most deadly cancers; the company currently has late-stage trials underway for testing the regimen’s efficacy for treating BRCA-mutated pancreatic cancer, adjuvant and metastatic BRCA-mutated breast cancers, as well as second-line gastric cancer.

The current expansion in collaboration with Myriad is expected to boost the success of AstraZeneca’s Lynparza in the area of pancreatic cancer. Currently almost 48,000 new cases of pancreatic cancer are diagnosed each year, with approximately 40,000 patients dying annually from the debilitating form of cancer in the US alone.

Mark Capone, president at Myriad Genetic Laboratories, seemed positive about the expanded collaboration with AstraZeneca, saying: "Pancreatic cancer is one of the few cancers for which survival has not improved substantially in the last 40 years, and the average life expectancy after diagnosis with metastatic disease is three to six months. Our collaboration with AstraZeneca is a big step forward in the fight against pancreatic cancer and in ensuring that personalized medicine becomes reality. BRAC Analysis CDx has the potential to quickly and accurately identify those patients who may be candidates for treatment with Lynparza and hopefully to accelerate better health outcomes," as per the press release by the company on Wednesday.

Myriad’s BRAC Analysis CDx was first approved in December last year to be used as a companion diagnostic for Lynparza in ovarian cancer patients. It became the first ever complex laboratory developed test (LDT) to be approved by the FDA under a pre-market approval application process. This was also the first regulatory approval for any LDT CDx test. BRAC Analysis CDx works as an in-vitro diagnostic device and uses genomic DNA taken from whole blood samples to identify various forms of BRCA1 and BRCA2 genes.

AstraZeneca shares traded up 0.53% to close at $68.79 on Wednesday. Myriad stock, on the other hand, was down 1.78% and closed at $34.77 yesterday.

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