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Nexavar cleared for thyroid cancer by FDA

Bayer and Onyx win expansion of oncology drug’s use in US
Bayer Nexavar sorafenib

Bayer and Onyx scored a third approval in the US for their oncology drug Nexavar after the Food and Drug Administration (FDA) approved the drug to treat metastatic differentiated thyroid cancer.

Nexavar (sorafenib) is already approved to treat certain forms of kidney and liver cancer, and the new use expands its potential market with around 60,000 people in the US diagnosed with thyroid cancer every year. 

Approval in radioactive iodine-refractory thyroid cancer - an indication which has also been filed in the EU - is expected to lend additional sales growth momentum to the product as Nexavar will add another 3,000 to 4,000 potential patients in each territory.

Analysts have suggested that could add another $300m a year to its peak sales. All told, Nexavar achieved global sales (excluding Japan) of $230m in the third quarter of the year - a rise of 7 per cent year-on-year.

The FDA's decision was based on the results of the DECISION study which showed a significant 41 per cent improvement in median progression-free survival (PFS) to 10.8 months in the sorafenib group compared with 5.8 months in the placebo arm.

Thyroid cancer patients whose disease progresses despite radiotherapy typically have a life expectancy of around three years at best, and often develop debilitating complications including metastases to the lungs and bone.

"Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies," said the FDA's Richard Pazdur, who heads the agency's Office of Hematology and Oncology Products.

Sorafenib blocks the enzyme RAF kinase, part of the RAF/MEK/ERK signalling pathway that controls cell division and proliferation, while also inhibiting the VEGFR-2/PDGFR-beta signalling cascade.

The drug is also in a phase III study in breast cancer called RESILIENCE, which should generate results in 2014, along with a trial called STORM looking at its role as an adjuvant treatment to prevent recurrence in hepatocellular carcinoma patients undergoing surgery or localised radiotherapy.

Eylea gets Japanese go-ahead

Meanwhile, in other good news for Bayer, the company was granted approval in Japan for its ophthalmic drug Eylea (aflibercept), developed in collaboration with Regeneron.

Japan's Ministry of Health, Labor and Welfare (MHLW) cleared the drug for the treatment of macular oedema following central retinal vein occlusion (CRVO), an indication which has already been approved in the US and Europe.

Article by
Phil Taylor

26th November 2013

From: Sales

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