Nexavar Submits sNDA for RAI-Refractory Differentiated Thyroid Cancer
Bayer Healthcare and Onyx announced that they have submitted a supplemental New Drug Application (sNDA) to the FDA for oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis.
The regulatory submission was based on data from the Phase 3 DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study.
A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer were randomized to receive 400mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo.
Nexavar is already approved for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.