Nexavar gains FDA ‘speed lane’ status for thyroid cancer
pharmafile | August 28, 2013 | News story | Research and Development, Sales and Marketing | Amgen, Nexavar, Onyx
Bayer and Onyx’s liver and kidney cancer pill Nexavar could be adding a new licence to its reporter after the FDA granted the treatment ‘priority status’ for thyroid cancer.
The German firm and partner Onyx, which has recently been acquired by Amgen, have gained a speedy review of their drug Nexavar (sorafenib) for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.
The FDA grants priority review to medicines that, if approved, would significantly improve the efficacy or safety of treatment for serious conditions.
With this status the US drugs regulator aims to complete its review within six months, rather than the standard ten-months, meaning the drug could be available by early next year.
Kemal Malik, head of global development, said: “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.”
The regulatory submission is based on data from the Phase III DECISION trial, which showed the pill extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo.
The median PFS was 10.8 months in patients treated with Nexavar, compared to 5.8 months in patients receiving placebo.
The drug is currently licensed in Europe to treat hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) for patients who have failed prior interferon-alpha or interleukin-2 based therapy, or are considered unsuitable for such therapy.
It made Bayer and Onyx just over $1 billion in 2012, but analysts predict a new licence could add about $200 million a year than it would have otherwise made, meaning peak sales could reach $1.6 billion by 2016.
New treatments for tough disease
Thyroid cancer has become the fastest-increasing cancer in the world in recent years and is the sixth most common cancer in women. There are more than 213,000 new cases of thyroid cancer annually and around 35,000 people die from thyroid cancer worldwide each year.
Papillary, follicular, Hürthle cell and poorly differentiated types of thyroid cancer are classified as ‘differentiated thyroid cancer’, accounting for around 94% 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.
Treatment for the disease in the US and Europe is limited to a handful of treatments, and includes AstraZeneca’s Caprelsa (vandetanib) that is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
The drug is expected to bring in just $112 million a year by 2016 according to analysts as there are ongoing safety concerns surrounding AZ’s treatment.
In November last year the FDA also approved Exelixis’s Cometriq (cabozantinib) for the treatment of patients with progressive metastatic MTC. Cometriq is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor.
Ben Adams
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