Ipsen’s Cabometyx can now be used as monotherapy to treat certain patients with liver cancer following a green light from regulators in Europe.
The drug, which is already cleared to treat advanced kidney cancer and medullary thyroid cancer (sold under the brand name Cometriq for the latter), has been shown in trials to extend life and delay disease progression in patients with advanced hepatocellular cancer (HCC) who have already received treatment with sorafenib.
The approval rides on the back of data from the Phase III CELESTIAL trial, which was stopped early after showing median overall survival of 10.2 months in patients taking Cabometyx (cabozantinib) and 8.0 months for those given a placebo.
The study also met all key secondary endpoints, including a statistically significant increase in median progression-free survival (PFS; 5.2 months versus 1.9 months) and objective response rates (4% versus 0.4%).
The drug’s approval in this setting “provides a much needed new option for HCC patients," noted Harout Semerjian, Ipsen’s chief commercial officer. "Until now, physicians in Europe had only one approved therapy for the 2nd line treatment of this aggressive and difficult-to-treat cancer," he added, higlighting the unmet need in this area.
“We are proud to offer Cabometyx as an innovative treatment that has been shown to extend survival in previously treated patients with HCC”.