Second-line new drug for advanced liver cancer! Ipsos' targeted cancer drug Cabometyx has been approved by the European Union

French pharmaceutical company Ipsen recently announced that the European Commission (EC) has approved a new adaptation of the target cancer drug Cabozantinix 20mg, 40mg and 60mg tablets as a single-drug therapy for adult patients with advanced hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
this approval is based on positive data from CELESTIAL, a global Phase III clinical study. The study, a randomized, double-blind, controlled study conducted at more than 100 clinical centers in 19 countries around the world, included 773 patients with advanced HCC who had previously received sorafenib and may have received two systemic cancer therapies and had sufficient liver function. In the study, patients were randomly assigned a 60 mg dose of cabozantinib or a placebo once a day at a 2:1 scale. The main endpoints of the study were total lifetimes (OS), secondary endpoints included objective mitigation rates and non-progressive lifetimes, and exploratory endpoints included patient reporting results, biomarkers, and safety.
data showed that the cabozantinib treatment group OS achieved statistically significant and clinically significant extensions compared to the placebo group when used in the second-line treatment of advanced HCC;
, Chief Commercial Officer of Ipsen, said, "Today's EC approval of Cabometyx will provide a very important new treatment option for the HCC patient population in Europe. So far, only one drug has been approved in Europe for second-line treatment for this invasive and incurable cancer. Cabometyx, an innovative therapy, has been shown to extend the survival of HCC patients who have been treated in the past. This new adaptation will strengthen ipsen's commitment to improving patients' lives by expanding the clinical benefits of Cabometyx in the treatment of solid tumors.
cabozantinib is an oral drug that plays an anti-tumor role by targeting the suppression of MET, VEGFR2, and RET signaling path pathps, killing tumor cells, reducing metastasis and inhibiting angiogenesty. Currently, cabozantinib capsule dosage forms are being sold under the brand name Cometriq for the treatment of advanced metastatic thyroid myelinoma (MTC) in the United States and for the treatment of advanced non-removable localized advanced or metastatic MTC in the European Union.
addition, cabozantinib tablets are being sold under the brand name Cabometyx for patients with advanced renal cell carcinoma (RCC) who have previously received vascular endodertic growth factor (VEGF) targeted therapy. In the United States and the European Union, Cabometyx was approved in April and September 2016 for the above-mentioned adaptations, with approved doses of 20 mg, 40 mg and 60 mg, with the recommended dose of 60 mg per day or oral. In May, Cabometyx was approved by the European Union for first-line treatment of mid- to high-risk late-stage RCC. On the U.S. side, Cabometyx was approved by the FDA on December 19, 2017 for first-line treatment for late-stage RCC.
, developed by Exelixis, ipsen signed an exclusive $855 million licensing agreement with Exelixis in February 2016 to obtain cabozantinib's commercialization rights outside the United States, Canada and Japan. In December 2016, the parties amended the licensing agreement to give ipsen the right to commercialize cabozantinib in Canada.
, Japanese drug company Takeda signed an exclusive licensing agreement with Exelixis, granting Cabozantinib exclusive commercial rights to treat all potential adaptive disorders in Japan. (Bio Valley)