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CHMP支持批准拜耳抗癌药Stivarga用于GIST的治疗

来源:生物谷 2014-07-01 09:13

2014年7月1日讯 /生物谷BIOON/ --拜耳(Bayer)6月27日宣布,抗癌药Stivarga(regorafenib)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Stivarga用于既往经2种酪氨酸激酶抑制剂(Gleevec、Sutent)治疗后病情恶化或不耐受的不可切除性或转移性胃肠道间质瘤(GIST)患者的治疗。欧盟委员会(EC)预计将于2014年第三季度做出最终审查决定。此前,Stivarga于2013年8月30日获欧盟批准用于转移性结直肠癌(mCRC)的治疗。

CHMP的积极意见是基于关键III期GRID研究的数据。数据显示,与安慰剂+最佳支持疗法(BSC)相比,Stivarga+BSC组合疗法使无进展生存期(PFS)取得了统计学意义的显著改善(4.8个月 vs 0.9个月,p<0.0001)。

目前,Stivarga已获美国、欧盟、日本批准,用于转移性结直肠癌(mCRC)的治疗。同时,该药已获美国和日本批准用于治疗胃肠道间质瘤(GIST)。Stivarga是FDA批准的第三个治疗胃肠道间质瘤(GIST)的药物,另2个药物为诺华的格列卫(Gleevec)、辉瑞的索坦(Sutent)。

胃肠道间质瘤(GIST)是癌细胞发生在胃肠道的一种肿瘤,患者多为老年人。GIST,由于其极具侵略性的特点,目前依然是尚未满足的医疗需求,同时治疗的选择也很有限,相关临床研究数据表明,Stivarga有望为那些经标准治疗后复发的患者提供一种重要的治疗方案。

Stivarga是一种口服多激酶抑制剂,在临床前研究中,regorafenib能够抑制数个促血管生成VEGF受体酪氨酸激酶,这些激酶在肿瘤的血管生成中发挥着重要作用。该药还可以抑制癌和肿瘤微环境中的多种激酶,包括VEGFR 1-3, KIT, RET, PDGFR及FGFR。Stivarga由拜耳开发,由拜耳和Onyx制药联合推广。(生物谷Bioon.com)

英文原文:Regorafenib from Bayer Recommended for Approval in the European Union for the Treatment of Gastrointestinal Stromal Tumors

Final decision from European Commission expected in the third quarter of 2014
Berlin, June 27, 2014 - The oncology compound regorafenib (Stivarga®) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. The decision of the European Commission on the approval is expected in the third quarter of 2014. Stivarga is already approved in the EU for the treatment of patients with metastatic colorectal cancer (mCRC).

"The recommendation by the CHMP for Stivarga brings us one step closer to fulfilling a serious unmet medical need for patients suffering from this rare but aggressive cancer" said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "As an oral multi-kinase inhibitor that targets multiple tumor pathways, Stivarga would provide a new option for those patients with GIST who have no other approved treatment alternatives. At Bayer, we are committed to developing treatments that truly make a difference for patients battling the toughest of cancers."

The CHMP decision is based on the results of the pivotal Phase III GRID trial which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC (HR=0.268 [95% CI 0.185-0.388], p<0.0001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm (p < 0.0001). The increase in PFS was consistent independent of patient age, sex, geographic region, prior lines of treatment or ECOG performance status.

The most frequently reported drug-related adverse events in regorafenib-treated patients versus placebo-treated patients, respectively, were: asthenia/fatigue, hand-foot skin reaction (HFSR) / palmar-plantar erythrodysesthesia (PPE), diarrhea, decreased appetite and food intake, hypertension, mucositis, dysphonia, infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever and nausea. The most serious adverse drug reactions in patients receiving Stivarga are hepatotoxicity, hemorrhage, and gastrointestinal perforation.

Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and published in November 2012 in the journal The Lancet.

Regorafenib is approved under the brand name Stivarga® in several countries worldwide, including the U.S., Europe and Japan, for the treatment of patients with mCRC. In several countries, including the U.S. and Japan, the product has also been approved for the treatment of GIST.

About the GRID Study
GRID (GIST - Regorafenib In Progressive Disease) was a randomized, double-blind, placebo-controlled, multi-center Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib.

Patients were randomized in a 2:1 ratio to receive either regorafenib plus BSC or placebo plus BSC to evaluate efficacy and safety. Treatment cycles consisted of 160 mg regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint was PFS, and secondary endpoints included OS, time to progression, disease control rate, tumor response rate, and duration of response. The safety and tolerability of the two treatment groups were also compared.

About Gastrointestinal Stromal Tumors (GIST)
GIST is the most common form of sarcoma arising from the muscle wall of the gastrointestinal tract. GIST represents a life-threatening malignancy if the disease has spread to other parts of the body (metastasized) or is unable to be surgically removed with curative intent. GIST affects an estimated 11-20 patients per million per year worldwide.

The discovery of oncogenic KIT kinase mutations in GISTs and the introduction of kinase inhibitor therapies have led to a rapid evolution in the understanding of these tumors. It is now established that 70-80% of GISTs harbor a KIT gene mutation, that these mutations lead to the continued activation of the kinase and that mutant KIT is a clinically important therapeutic target in GIST.

About Stivarga® (Regorafenib)
Stivarga® (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.

Stivarga is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries.

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