The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended for approval of the oral multi-kinase inhibitor sorafenib (Nexavar) to treat patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexavar is co-developed by Onyx Pharmaceuticals, an Amgen subsidiary, and Bayer HealthCare Pharmaceuticals, except in Japan where Bayer manages all development.
In November 2013, the European Commission (EC) has granted an orphan drug designation for sorafenib to treat follicular and papillary thyroid cancer.
The decision of the EC on the approval is expected by mid-2014.
In November 2013, the US Food and Drug Administration (FDA) had approved sorafenib for this indication.
Bayer HealthCare member of the Executive Committee and head of Global Development Joerg Moeller said the recommendation by the CHMP for sorafenib in differentiated thyroid cancer is an important milestone because it brings patients one step closer to a new treatment option for this difficult-to-treat form of thyroid cancer.
"Nexavar is already approved for patients with hepatocellular carcinoma and advanced renal cell carcinoma in countries around the globe, and the CHMP's positive decision in this third indication addresses another serious unmet medical need," Moeller said.
The recommendation is based on data from the Phase III DECISION trial, in which sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the trial, compared to placebo, which represents a 41% reduction in the risk of disease progression or death for patients who received sorafenib compared to placebo-treated patients.
Median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.