EU CHMP recommends approval of Cabometyx for differentiated thyroid carcinoma.- Exelixix/Ipsen
Exelixis announced that its partner Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.
The CHMP recommendation is based on results from COSMIC-311, the phase III pivotal trial that demonstrated significant improvement in progression-free survival (PFS) with Cabometyx versus placebo in patients with RAI-refractory DTC who progressed after up to two prior VEGFR-targeted therapies. COSMIC-311 was the basis for the FDA approval of Cabometyx in September 2021 for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following VEGFR-targeted therapy and who are RAI-refractory or ineligible. Cabometyx is currently approved in the European Union as a monotherapy for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy, for previously untreated intermediate- or poor-risk advanced RCC and for hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. Cabometyx in combination with Opdivo (nivolumab) is approved as a first-line treatment for advanced RCC.
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