Bayer HealthCare and Onyx Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted priority review designation to the supplemental New Drug Application (sNDA) for Nexavar (sorafenib) tablets, for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

"We welcome this priority review as it supports our ongoing effort to make more treatment options available for cancer patients who until now have only limited or no treatment options,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and head of Global Development.

The FDA grants priority review to medicines that, if approved, would significantly improve the efficacy or safety of treatment for serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete priority review within six months, rather than the standard ten-month review cycle.

The regulatory submission is based on data from the phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled trial. In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo (HR=0.587 [95% CI, 0.454-0.758]; p<0.0001), which represents a 41 per cent reduction in the risk of progression or death for patients who received sorafenib compared to placebo-treated patients. The median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.

The safety and tolerability profile of sorafenib for patients in the trial was generally consistent with the known profile of sorafenib. The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhoea, alopecia, rash/desquamation, fatigue, weight loss and hypertension. Results from the trial were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013.

The DECISION trial was an international, multicenter, placebo-controlled study. A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (papillary, follicular, Hürthle 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 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients).

Thyroid cancer has become the fastest-increasing cancer in the world in recent years and is the sixth most common cancer in women.

Papillary, follicular, Hürthle cell and poorly differentiated types of thyroid cancer are classified as “differentiated thyroid cancer” and account for approximately 94 per cent of all thyroid cancers. While the majority of differentiated thyroid cancers are treatable with treatment options such as resection and/or radioactive iodine (RAI), RAI-refractory differentiated thyroid cancer is more difficult to treat and is associated with a lower patient survival rate.

Nexavar, an oral anti-cancer therapy for liver cancer and for the treatment of patients with advanced kidney cancer, is currently approved in more than 100 countries worldwide. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials.