Germany-based Bayer HealthCare and US-based Onyx Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Nexavar (sorafenib), an oral multi-kinase inhibitor, for the treatment of patients with differentiated thyroid cancer (DTC).
Following a priority review, the FDA has approved Nexavar for the treatment of locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine (RAI) treatment.
Bayer HealthCare executive committee member and global development head Dr Kemal Malik noted Nexavar is an important treatment option for patients with certain kinds of cancers, and this latest indication for RAI-refractory differentiated thyroid cancer addresses a serious unmet medical need.
"Bayer is committed to exploring the full clinical potential of our therapies to make a difference in the lives of patients and physicians," Malik added.
Based on the data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyroid caNcer) study, the FDA has approved sorafenib.
The DECISION study is an international, multicenter, placebo-controlled study.
In this study, a total of 417 patients with locally advanced or metastatic, progressive, 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).
Around 96% of the randomized patients had metastatic disease.
Progression-free survival is the primary endpoint of the study. When compared to placebo, sorafenib significantly extended the progression-free survival.
In this trial, Sorafenib has shown generally consistent safety and tolerability profile. The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhea, alopecia, weight loss, fatigue, hypertension and rash.
Results from the DECISION trial were presented at the American Society of Clinical Oncology annual meeting in June 2013.
Onyx and Bayer have co-developed Nexavar. Bayer manages all development except in Japan. Both companies co-promote the drug in the U.S.
Bayer has exclusive marketing rights outside the US and the two companies share profits globally, excluding Japan.
