Exelixis, Inc. (NASDAQ:EXEL) and Ipsen SA (EPA:IPN) have a new phase of development for their Cabometyx™ (cabozantinib). The treatment that comes in 20, 40, and 60mg a which is use in the treatment of advanced renal cell carcinoma (RCC) in adults has received positive recommendation from Committee for Medicinal Products for Human Use (CHMP). The recommendation was also backed up by the scientific committee of the European Medicines Agency (EMA) for marketing purposes.
Speaking about the long-awaited approval, Chief Executive Officer of Ipsen, David Meek expressed the company’s enthusiasm calling it a significant milestone for both Exelixis and Ipsen. The treatment will be use in patients with advanced renal cell carcinoma but who must have received one prior therapy. The achievement is a shared undertaking by the two companies in delivering modern treatments to advance the treatment of cancer that has become a threat to many households.
More about the Recommendation from CHMP and EMA
The two bodies are entrusted with reviewing and giving approvals to medicinal products that are expected to be part of a major public. This particular recommendation means that the rug has met the terms and conditions that the bodies consider being of public interest and especially in addressing a serious unmet medical need.
The validation of Exelixis’ Marketing Authorization Application (MAA) for Cabometyx gives it 150-day review legibility by the European Commission which has an upper hand in approving medicines in over 28 countries of the European Union. Recommendations for use of the product shall then be described in the Summary of Product Characteristics (SmPC).
What should be known about the METEOR Phase 3 Pivotal Trial?
That it met its primary endpoint of significantly improving PFS having been carried out at about 200 sites across 26 countries. Patients were randomized 1:1 to receive a daily dose of 60 mg of Cabometyx. The Secondary endpoints had everything to do with OS and objective reaction rate in all patients who were enrolled from Western Europe, North America, and Australia
