NICE approves Bayer’s Nexavar for primary liver cancer

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NICE has recommended Bayer's Nexavar (sorafenib) for use on NHS England for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have a Child-Pugh grade A liver impairment and who have failed or are unsuitable for surgical or loco-regional therapies.

Nexavar has been available on the Cancer Drugs Fund since 2010, but this decision from NICE will mean physicians and patients will now have routine access to the drug.

“Nexavar, funded through the Cancer Drugs Fund, has been the only option of advanced liver cancer patients in England," said Amanda Cunnington, head of patient access, Bayer, UK. "The new guidance from NICE now puts this funding on a more secure footing so patients and physicians in England will have routine access to a much needed standard of care.

“Our work does not stop there as we have also recently submitted Stivarga (regorafenib) for NICE and SMC review with the hope to also provide the first approved second-line treatment option for patients with HCC, who have previously been treated with Nexavar.”
HCC is the most common form of liver cancer and is responsible for approximately 70-85 percent of the total primary liver cancer burden worldwide. It is recognised as among the most chemo-resistant tumour types. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. In England, there are approximately 4,500 new cases of liver cancer diagnosed each year.

Nexavar is a multikinase inhibitor with both anti-proliferative and anti-angiogenic properties. In Europe, it is licenced for the treatment of hepatocellular carcinoma; for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; and for progressive, locally advanced or metastatic differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma refractory to radioactive iodine.
In a pivotal phase III, placebo-controlled study of 602 patients with advanced hepatocellular carcinoma, median overall survival and the time to radiologic progression were nearly 3 months (2.8 months) longer for patients treated with Nexavar than for those given placebo. The most frequent adverse events in the Nexavar group were diarrhoea, weight loss, hand-foot skin reaction and hypophosphatemia.

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