CHMP建议批准拜耳regorafenib用于转移性结直肠癌(mCRC)治疗

拜耳（Bayer）上周末宣布，药物regorafenib获得了欧盟委员会（EC）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准将regorafenib用于既往治疗过或不适用于当前可用疗法（包括基于氟尿嘧啶的化疗，抗VEGF疗法、抗EGFR疗法）的转移性结直肠癌（mCRC）成人患者的治疗。预计EC将于2013年第三季度作出审查决定。

CHMP的积极意见，是基于关键性III期CORRECT临床试验数据，结果表明，与安慰剂相比，regorafenib显著延长了总生存期（OS），并显著延缓了癌症的进展。

Regorafenib是首个也是唯一一种在转移性结直肠癌（mCRC）中表现出总生存期益处的多激酶抑制剂。

Regorafenib品牌名为Stivarga，已获包括美国及日本在内的一些国家批准，用于mCRC的治疗，同时该药于今年2月获FDA批准用于胃肠道间质瘤（GIST）的治疗。

英文原文：Bayer AG : Bayer’s Regorafenib Recommended for Approval in the European Union for the Treatment of Metastatic Colorectal Cancer

Regorafenib shown in a pivotal Phase III trial to extend overall survival in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after previous treatments

Berlin, June 28, 2013- Bayer's oncology compound regorafenib has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy. The decision of the European Commission on the approval is expected in the third quarter of 2013.

"The recommendation by the CHMP for regorafenib is an important milestone for Bayer and brings us one step closer to providing an innovative new treatment option for patients with metastatic colorectal cancer," said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "Bayer is committed to developing new therapies in difficult-to-treat diseases like mCRC where there continues to be an unmet medical need for additional treatments, and we are delighted that regorafenib provides a potential new treatment option for patients and their physicians."

"The medical community constantly strives to find new and better treatment options in the fight against cancer. There are currently limited choices in mCRC so the potential approval of regorafenib in Europe can give patients and physicians new hope," said Eric Van Cutsem, Lead CORRECT investigator, University Hospital Gasthuisberg Leuven, Belgium. "In the pivotal Phase III CORRECT trial, regorafenib has been shown to prolong overall survival and slow the progression of cancer in patients whose disease had progressed after treatment with currently available therapies. It is the first and only multikinase inhibitor to show an overall survival benefit in mCRC and we are very encouraged by the positive opinion from CHMP."

The CHMP recommendation was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated withregorafenib or placebo after failure of standardtherapy) trial. The study results showed that regorafenib plus BSC significantly improved both overall survival (OS) (HR=0.77, 1-sided p-value=0.0052) and progression-free survival (PFS) (HR=0.49, 1-sided p-value <0.000001) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. In the study, median OS was 6.4 months with regorafenib versus 5.0 months with placebo; median PFS was 1.9 months with regorafenib versus 1.7 months with placebo.

In the CORRECT study, the most frequently observed adverse drug reactions (equally or greater than 30%) in patients receiving regorafenib were asthenia/fatigue, decreased appetite and food intake, hand-foot-skin reaction/ palmar-plantar erythrodysesthesia, diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. In regorafenib clinical trials the most serious adverse drug reactions in patients receiving regorafenib were hepatotoxicity, hemorrhage and gastrointestinal perforation.

Full results from the CORRECT study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and published in the journal The Lancet in January 2013.

Regorafenib is approved under the brand name Stivarga® in several countries, including the USA and Japan, for the treatment of mCRC. It has also received U.S. approval for the treatment of patients with gastrointestinal stromal tumors (GIST) in February 2013. The NDA for regorafenib for the treatment of GIST filed in Japan in December 2012 was granted priority review.