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Second approval in US for Bayer-Onyx' Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

Bayer headquarters

Bayer and Onyx' cancer drug Stivarga has been cleared in the US for the treatment of patients with advanced gastrointestinal stromal tumours (GIST), its second indication.

Stivarga (regorafenib) has been given the go-ahead by the FDA to treat advanced GIST that cannot be removed surgically and have failed to respond to prior treatment with Novartis' Gleevec (imatinib) and Pfizer's Sutent (sunitinib), the only other drugs approved in the US for GIST.

The decision adds to Stivarga's current approval as a third-line treatment for patients with metastatic colorectal cancer whose disease has progressed after standard therapy. Bayer has said in the past the drug could achieve sales of up to $1.3bn if it secures approval in multiple cancer indications.

Bayer also reported that regorafenib has been granted priority review status for GIST by Japan's Ministry of Health, Labour and Welfare (MHLW).

Stivarga is an oral multi-kinase inhibitor, which blocks several enzymes that promote cancer growth, and in trials delayed progression-free survival by almost four months compared to placebo in patients whose cancer had progressed despite Gleevec and Sutent therapy.

The latest approval continues a great few months for Onyx, which started 2012 with just one drug on the market - Bayer-partnered Nexavar (sorafenib) for liver and kidney cancer - but has now added multiple myeloma drug Kyprolis and Stivarga to its portfolio. Meanwhile, Nexavar should be filed this year for thyroid cancer and possibly also breast cancer.

Stivarga got off to a good start in the US following its launch in September, with Onyx booking $8m in royalty revenues. Bayer is scheduled to deliver its fourth quarter results statement later this week.

"The second approval for … Stivarga in the US reveals the drug's potential to fulfil serious unmet medical needs for patients with cancer who require new medicines that continue to slow the progression of their disease," said Kemal Malik, Bayer's head of global development.

26th February 2013

From: Sales

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