Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

CHMP recommendation follows September 2021 U.S. FDA approval of CABOMETYX in this setting –

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today 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 European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation, and a final decision on the application is expected in the coming months.

“The CHMP’s recommendation is an important milestone for our partner Ipsen in their efforts to bring CABOMETYX to patients in Europe with radioactive iodine-refractory differentiated thyroid cancer that has progressed following prior systemic therapy,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer at Exelixis. “These patients have a poor prognosis, and there are currently no standard treatment options approved in Europe following progression on anti-VEGFR therapy. We look forward to hearing the European Commission’s decision in the coming months, with the hope that a new therapy will soon be available to these patients and their caregivers.”

The CHMP recommendation is based on results from COSMIC-311, the phase 3 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 U.S. Food and Drug Administration (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.

About COSMIC-311
COSMIC-311 was a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that enrolled 258 patients at 164 sites globally. Patients were randomized in a 2:1 ratio to receive either CABOMETYX 60 mg or placebo once daily.

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