Germany’s Bayer and its US partner Onyx Pharmaceuticals say they plan to file for approval “as rapidly as possible” for Nexavar to treat liver cancer after a study showed the drug significantly prolongs life for patients in the advanced stages of the disease.
The companies said that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from a Phase III trial, called SHARP, in patients with advanced hepatocellular carcinoma and based on an interim analysis, has concluded that the study met its primary endpoint resulting in superior overall survival in those patients receiving Nexavar (sorafenib) versus placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms, so Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar.
The firms noted that given the “limited approved systemic therapies for this disease,” they will “continue discussions with health authorities worldwide” in order to get the drug filed as soon as possible. Nexavar is currently approved as a treatment for advanced kidney cancer in around 50 countries.
The news is a huge boost for Bayer and Onyx, as the firms were rocked by clinical data from a Phase III trial last December which revealed that Nexavar was not effective in treating patients with advanced melanoma. The compound, as a single agent or combination treatment, is also being studied in a wide range of cancers, including non-small cell and breast cancer and Bayer has said that it believes Nexavar has blockbuster potential.
Kogenate gets EU approval for new indication
Meantime, Bayer has also announced that its well-established drug Kogenate (recombinant antihaemophilic factor) has received European Union approval for continuous infusion in haemophilia A patients undergoing major surgery, the first drug of its type to get the green light from the EU for that indication.
The firm said that a recent clinical study rated haemostasis with continuous infusion of Kogenate to be ‘excellent’ (87%) or ‘good’ (13%) in all patients. Bleeding and blood loss during surgery were within expected ranges and treatment was well tolerated without any undue safety concerns.