Cabometyx is an inhibitor of the tyrosine kinases c-Met and VEGFR2, discovered and developed by genomics-based drug discovery company Exelixis
Ipsen gets EC approval for Cabometyx. (Credit: Christina Victoria Craft on Unsplash)
French pharmaceutical company Ipsen has secured the European Commission (EC) approval for Cabometyx (cabozantinib) to treat a type of differentiated thyroid carcinoma (DTC) in adults.
The European regulator indicated Cabometyx as monotherapy for adult patients with locally advanced or metastatic DTC, who are not eligible for radioactive iodine (RAI).
Cabometyx is a small molecule inhibitor of the tyrosine kinases c-Met and VEGFR2, discovered and developed by genomics-based drug discovery company Exelixis.
The drug was previously approved in the US, as a monotherapy and in combination with other drugs, in several cancer indications, along with EU and other countries worldwide.
In 2016, Ipsen has obtained exclusive rights from Exelixis for the commercialisation and clinical development of Cabometyx outside of the US and Japan.
In 2017, Exelixis has granted Takeda exclusive rights for the commercialisation and clinical development of cabozantinib in Japan, retaining the rights in the US.
With the EC approval, Ipsen is allowed to commercialise Cabometyx in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland, in this indication.
Exelixis product development and medical affairs executive vice president Vicki Goodman said: “We are excited that Cabometyx will now be available in Europe for patients with locally advanced or metastatic differentiated thyroid carcinoma who have progressed during or after prior systemic therapy, that previously had no approved standard treatment options.
“The European Commission approval is an additional step in our partnership with Ipsen to provide new treatment options for more eligible patients with difficult-to-treat cancer types.”
The EC approval is based on results from the COSMIC-311, a multicentre, randomised, double-blind, placebo-controlled Phase 3 trial in 258 patients at 164 sites worldwide.
The primary endpoints of the study include progression-free survival (PFS) in the intention-to-treat population along with an objective response rate in the first 100 random patients. The safety, overall survival and quality of life include the additional endpoints.
In the study, Cabometyx has met the primary endpoint of significant improvement in progression-free survival (PFS) in patients with RAI-refractory DTC, compared to placebo.
The treatment showed a significant reduction in the risk of disease progression or death by 78% compared to placebo, at a median follow-up of 6.2 months.
It has also met the other primary endpoint, the objective response rate at a median follow-up of 8.9 months, but did not meet the criteria for statistical significance.
Cabometyx showed a safety profile in the COSMIC-311, consistent with that previously observed for Cabometyx, where adverse events were managed with dose modifications.
Ipsen chief medical officer Hildemann said: “Confirmation of the approval of Cabometyx for this difficult-to-treat cancer is welcome news for patients and treating physicians.
“We are delighted that the European Commission has recognised the strength of the COSMIC-311 data and the possibilities that Cabometyx can deliver for people living with radioactive-iodine-refractory differentiated thyroid cancer.”