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.
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。”