US regulator shows Nexavar green light
pharmafile | November 25, 2013 | News story | Sales and Marketing | Bayer, Cancer, FDA, Nexavar, Onyx, thyroid
The FDA has extended the indication of liver and kidney cancer pill Nexavar to treat late-stage differentiated thyroid cancer.
It is big news for its co-marketers Bayer HealthCare and Onyx Pharmaceuticals: the drug made them just over $1 billion last year, but this may now rise significantly.
Analysts have predicted that the new licence for Nexavar (sorafenib) could add about $200 million a year, meaning peak sales could reach $1.6 billion by 2016.
The FDA gave the drug priority review in this indication – in part because thyroid cancer is the fastest-increasing cancer in the world in recent years and the sixth most common cancer in women.
“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases,” he added.
There are more than 213,000 new cases of thyroid cancer annually and around 35,000 people die from thyroid cancer worldwide each year – 1,850 of them in the US this year, it is estimated.
‘Differentiated’ thyroid cancer is a definition which includes papillary, follicular and Hürthle cell, accounting for around 94% of all thyroid cancers.
While the majority are treatable with 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.
Treatment for the disease in the US and Europe is limited to a handful of treatments, and includes AstraZeneca’s Caprelsa (vandetanib).
Nexavar inhibits multiple proteins in cancer cells, limiting their growth and division – and the drug’s new indication is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to RAI treatment.
In trials it increased progression-free survival by 41%, with half of patients receiving Nexavar living without cancer progression for at least 10.8 months – compared to at least 5.8 months for patients receiving placebo.
Adam Hill
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