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Bayer/Onyx Pharmaceuticals: Nexavar Approval in Liver Cancer Will Boost Sales

Posted on: Wednesday, 21 November 2007, 06:00 CST

Bayer and Onyx Pharmaceuticals' Nexavar has received yet more positive regulatory news, winning approval in the US for the treatment of hepatocellular carcinoma. The targeted therapy can now expect to be adopted as the standard first-line treatment. Coupled with the recent approval in the EU for the same indication, overall sales of the drug are likely to be substantially boosted.

The FDA has approved a supplemental new drug application (sNDA) for Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib) in the treatment of unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer. This follows the EMEA's decision at the end of October 2007 to approve the drug in the same indication. Nexavar is now the only drug approved for liver cancer in either the US or EU.

Nexavar targets a range of tyrosine kinases, including those involved in promoting tumor angiogenesis (the growth of new blood vessels) and cell proliferation. The drug was first approved for renal cell carcinoma in the US in December 2005 and in the EU in July 2006.

Nexavar's sNDA was approved under priority review on the basis of data from a placebo-controlled Phase III trial showing that the median overall survival in Nexavar-treated patients was 10.7 months, compared to 7.9 months in patients who received a placebo. This represents a 44% improvement in overall survival.

HCC accounts for between 8590% of cases of liver cancer and is the sixth most common cancer in the world. Patients diagnosed with liver cancer have a particularly poor prognosis, partly due to the lack of effective treatment options in this disease area and tendency for diagnosis at an advanced stage. The five-year overall survival rate is just over 10%.

Given the previous lack of approved treatment options in HCC and proven survival benefit, Nexavar is now likely to be widely adopted as the standard first-line treatment for this indication. The drug will benefit greatly from its first-to-market advantage and the fact there are relatively few late-phase pipeline drugs set to challenge its status as the standard-of-care in the near future. Overall sales of the drug are therefore likely to be significantly bolstered by the recent EU and US approvals in HCC.

It should be noted, however, that a potentially more lucrative milestone is within Nexavar's reach. In Japan (where HCC approval is currently under review for Nexavar), HCC incidence is far higher than in the other major pharmaceutical markets: around 37,000 cases of HCC will be diagnosed in Japan in 2007 compared to just 14,000 in the US.

Source: Datamonitor

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