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.