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Liver cancer trial halted early as Bayer/Onyx' Nexavar shines
 
 
  28/08/2007
 
The good news just keeps coming in for Bayer and partner Onyx Pharmaceuticals' Nexavar as the firms ended a late-stage trial early on the back of more positive results for the compound as a treatment for liver cancer.
 
A review by an independent data monitoring committee found that Nexavar (sorafenib) significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific Phase III trial of patients with advanced hepatocellular carcinoma, the most common form of liver cancer. As a result, the trial will be stopped to allow all the 226 patients from sites in China, Korea and Taiwan to receive treatment with the drug and data from the study will be submitted for presentation at an upcoming scientific meeting.
 
News of the Asia-Pacific study comes days after the firm's supplemental New Drug Application for Nexavar was granted priority review status by the US Food and Drug Administration. The sNDA is based on positive data from the Phase III SHARP trial which demonstrated that the drug extended overall survival by 44% in patients with HCC versus placebo and the same data also provided the basis for a marketing application to the European Medicines Agency earlier this summer. Additional regulatory submissions are being finalised, Bayer announced.
 
"Liver cancer incidence continues to rise in the Asia-Pacific region, due to the high prevalence of hepatitis B virus infection," said Ann-Lii Cheng, principal investigator and professor of medicine at National Taiwan University Hospital. "These study results confirm that Nexavar's efficacy and tolerability in liver cancer extends across ethnic groups and geographies and suggest that [the drug] could meet a tremendous unmet need".
 
Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer, and Bayer recorded revenues of 81.3 million euros from the drug in the second quarter, but the liver indication is exciting analysts even more. Onyx' share price in particular is benefiting from all this positive news flow and its stock ended the day up 10.2% to $37.04.
 
Bayer/Onyx' Nexavar gets US priority review for liver cancer
 
21/08/2007
 
The possibility of Bayer and partner Onyx Pharmaceuticals' Nexavar being approved as a liver cancer treatment appears to be moving closer with the news that US regulators will give it a quicker-than-usual review.
 
The firm's supplemental New Drug Application submitted in June for Nexavar (sorafenib) for the treatment of patients with hepatocellular carcinoma, the most common form of liver cancer, has been granted priority review status by the US Food and Drug Administration. The process is used to look at investigational agents that address unmet medical needs and means that the agency will take action on the drug before the end of the year ie within six months of the date it received the sNDA.
 
The sNDA is based on positive data from the Phase III SHARP trial which demonstrated that the drug extended overall survival by 44% in patients with HCC versus placebo and the study revealed no significant differences in serious adverse event rates between Nexavar and placebo-treated groups. The same data also provided the basis for a marketing application to the European Medicines Agency earlier this summer.
 
Susan Kelley, vice president of oncology at Bayer, said that the priority review "underscores the potential of Nexavar to be a significant advance in the treatment of liver cancer," and if approved, it would be the first FDA-approved therapy "for patients battling this devastating disease". Onyx chief medical officer Hank Fuchs added that "the incidence of liver cancer continues to rise in the USA and around the world, highlighting the significant need for new therapies," and Nexavar's "unique combination of multi-targeted activity, tolerability and oral dosing may meet additional unmet needs in cancer".
 
Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer and Bayer recorded revenues of 81.3 million euros from the drug in the second quarter.
 
 
 
 
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