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Bayer and Onyx get liver cancer approval for Nexavar in EU
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31/10/2007
www.pharmatimes.com
As expected, Bayer and partner Onyx Pharmaceuticals' Nexavar has received the green light in Europe to be sold as a treatment for liver cancer.
The German firm noted that European Commission has granted marketing authorisation to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma, making it "the first and only approved systemic drug therapy for liver cancer" and the only one shown to significantly improve overall survival in patients with the disease.
The approval, which comes just over a month after European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on the drug, is based on positive data from the Phase III SHARP trial. That study 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.
Based on the SHARP data, a supplemental New Drug Application for Nexavar was granted priority review status by the US Food and Drug Administration in August and since then a regulatory filing in Japan has been submitted. Arthur Higgins, head of Bayer HealthCare, added that the approval of Nexavar, a novel multi-kinase inhibitor, "represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options," noting that "this milestone will likely establish Nexavar as the standard of care in HCC".
Nexavar, which is currently approved in more than 50 countries to treat advanced kidney cancer, brought in 60 million euros in the second quarter but getting approval for the liver cancer indication is going to push that figure much higher and Bayer is looking to get it onto the market as soon as possible.
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.
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