Bayer HealthCare took another step toward a planned marketing application for the cancer drug regorafenib today as it unveiled the late-stage colorectal cancer data that it plans to take to regulators later this year. Late last year Bayer tapped regorafenib--sometimes referred to by industry wags as the "son of Nexavar"--as one of the pharma company's top four blockbuster contenders, as CEO Marijn Dekkers vowed to stand by its multibillion-dollar strategy on drug development.
Investigators report that the treatment improved the median overall survival rate of metastatic patients by 29%, with the drug arm demonstrating a 6.4 month overall survival rate while advanced patients who had already failed standard therapy survived a median average of 5 months on a placebo. Metastatic patients in the drug arm also experienced high rates of fatigue, skin reactions and diarrhea, according to Bayer.
Bayer already knew it had a positive batch of data coming late last year when researchers unblinded the Phase III CORRECT study on the advice of the monitoring committee so they could give regorafenib to the placebo arm.
Today's news is likely to inspire some smiles at Onyx ($ONXX) as well. The biotech landed a $160 million payday and won a 20% royalty stake in the drug last fall after prevailing in a bitter dispute over the rights to regorafenib, which bears a close resemblance to the jointly-owned Nexavar. Onyx had accused Bayer researchers of secretly developing analogs of Nexavar before the two partners finally managed to reach an agreement on ownership.
"It will be very likely that they'll grant approval because there's nothing else like it," Axel Grothey, a professor of oncology at the Mayo Clinic, tells Bloomberg. The next hurdle will be payers, who have been frowning over expensive new cancer drugs that offer only marginal improvements in median survival.
- read the press release
- here's the report from Bloomberg