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EU nod for Bayer’s Stivarga as Nexavar gets US priority review

Advances pharma company’s ambitions in cancer

Bayer symbol

There was a brace of good news on the oncology front for Bayer this week, with Stivarga securing approval in the EU for colorectal cancer and Nexavar given a priority review in the US for thyroid cancer.

Stivarga (regorafenib) was given a green light by the European Commission for the treatment of adult patients with metastatic colorectal cancer in whom other therapies were unsuitable or ineffective.

The approval means that Stivarga is now approved in the top three pharma markets worldwide - the US, EU and Japan - and keeps the product on track for achieving a predicted $1bn-plus in peak sales.

Earlier this month Stivarga was cleared for gastrointestinal stromal tumours (GIST) in Japan, adding to an earlier approval in colorectal cancer, and has been approved for both indications in the US. The product is still rolling out but has been growing at a rapid rate, adding €87m to Bayer's top-line in the first six months of the year.

Meanwhile, Nexavar (sorafenib) moved closer to approval in a third indication - differentiated thyroid cancer - after the US Food and Drug Administration (FDA) gave the drug a priority review. 

Nexavar is already approved in the US for liver and kidney cancers, and achieved €373m in sales in the first six months of this year, but there have been signs that sales have started to plateau a little with turnover actually a little down on the same period of 2012.

The priority review has been given for Nexavar in the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer, and the FDA is now due to deliver a verdict on the dossier before the end of the year.

This category of thyroid cancer patients numbers between 6,000 and 8,000 in the US and Europe and while many can be cured using existing therapies, a proportion fail to respond to any treatment so new therapies are still needed. Bayer filed for approval of the thyroid cancer indication in the EU in June, at the same time as its US application.

Both submissions were based on the phase III DECISION trial, which tested first-line Nexavar treatment in patients who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer.

The results, which were presented at the ASCO annual meeting in June, showed that Nexavar extended progression-free survival to 10.8 months compared to 5.8 months with placebo; an increase of 41 per cent.

The approvals are also great news for Onyx, which agreed to be taken over by Amgen in a $10.4bn deal earlier this week.  Onyx earns royalties on sales of Stivarga and Nexavar and has co-promotion rights to Stivarga in the US.



Article by
Phil Taylor

30th August 2013

From: Sales



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