FDA批准Cabometyx用于治疗经验丰富的HCC患者

StephenW

FDA News
FDA approves Cabometyx for treatment-experienced patients with HCC
January 15, 2019

Exelixis has announced it has received FDA approval for Cabometyx to treat patients with hepatocellular carcinoma who previously underwent treatment with Nexavar, according to a press release.

“This new indication for Cabometyx is an important treatment advance for patients with this aggressive form of liver cancer, a community in need of new therapeutic options,” Michael M. Morrissey, PhD, president and CEO of Exelixis, said in the release. “This approval is an important milestone as we continue to explore how Cabometyx may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma.”

Approval was based on results from the CELESTIAL phase 3 trial of Cabometyx (cabozantinib) for patients with HCC who previously received Nexavar (sorafenib, Bayer).

During the trial, patients who received cabozantinib had significantly improved rates of overall survival (10.2 vs. 8 months; HR = 0.76; 95% CI, 0.63-0.92) and progression-free survival (5.2 vs. 1.9 months; HR = 0.44; 95% CI, 0.36-0.52) compared with placebo. Additionally, patients who received cabozantinib were more likely to achieve partial response or stable disease compared with placebo (64% vs. 33%).

The most common grade 3 or grade 4 adverse events among patients who received cabozantinib included palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase, fatigue and diarrhea. Treatment-related grade 5 adverse events occurred in six treated patients and included hepatic failure, esophagobronchial fistula, portal vein thrombosis, upper gastrointestinal hemorrhage, pulmonary embolism and hepatorenal syndrome.

“Patients with this form of advanced liver cancer have few treatment options, particularly once their disease progresses following treatment with sorafenib,” Ghassan K. Abou-Alfa, MD, from the Memorial Sloan Kettering Cancer Center in New York and lead trial investigator, said in the release. “The results of the CELESTIAL trial demonstrate that Cabometyx has the efficacy and safety profile to become an important new therapy in our efforts to slow disease progression and improve treatment outcomes.”

According to the release, Exelixis’ partner Ipsen received approval in November 2018 from the European Commission for cabozantinib as monotherapy for HCC in adults with sorafenib experience.

Exelixis and Ipsen have also partnered for a phase 3 trial designed to evaluate cabozantinib in combination with atezolizumab vs. sorafenib for previously untreated advanced HCC.

Reference: www.exelixis.com

StephenW

FDA新闻
FDA批准Cabometyx用于治疗经验丰富的HCC患者
2019年1月15日

根据一份新闻稿，Exelixis已宣布已获得FDA批准Cabometyx用于治疗之前接受过多吉美治疗的肝细胞癌患者。

Exelixis公司总裁兼首席执行官Michael M. Morrissey博士在发布会上表示，“Cabometyx的新适应症是这种侵袭性肝癌患者的重要治疗进展，这是一个需要新治疗选择的社区。” “这一批准是一个重要的里程碑，因为我们将继续探索Cabometyx如何使患有肾细胞癌以外难以治疗的癌症患者受益。”

批准是基于Cabometyx（cabozantinib）的CELESTIAL 3期试验的结果，该试验用于之前接受Nexavar（索拉非尼，拜耳）的HCC患者。

在试验期间，接受cabozantinib治疗的患者总生存率显着提高（10.2对8个月; HR = 0.76; 95％CI，0.63-0.92）和无进展生存率（5.2对1.9个月; HR = 0.44;与安慰剂相比，95％CI，0.36-0.52）。此外，与安慰剂相比，接受卡博替尼治疗的患者更有可能达到部分缓解或疾病稳定（64％对33％）。

接受卡博替尼治疗的患者中最常见的3级或4级不良事件包括手掌 - 足底红斑感觉异常，高血压，天冬氨酸氨基转移酶升高，疲劳和腹泻。治疗相关的5级不良事件发生在6名接受治疗的患者中，包括肝功能衰竭，食管支气管瘘，门静脉血栓形成，上消化道出血，肺栓塞和肝肾综合征。

“患有这种形式的晚期肝癌的患者几乎没有治疗选择，特别是在索拉非尼治疗后疾病进展时，”来自纽约Memorial Sloan Kettering癌症中心的Ghassan K. Abou-Alfa医学博士和首席试验研究员表示在发布中。 “CELESTIAL试验的结果表明，Cabometyx具有有效性和安全性，可成为我们减缓疾病进展和改善治疗效果的重要新疗法。”

根据该发布，Exelixis的合作伙伴Ipsen于2018年11月获得了欧洲委员会对卡博替尼的批准，作为具有索拉非尼经验的成人的HCC单药治疗。

Exelixis和Ipsen还合作进行了一项3期试验，旨在评估cabozantinib联合atezolizumab与索拉非尼治疗先前未治疗的晚期HCC。

参考：www.exelixis.com