Phase 1 of Bayer’s liver cancer plan is complete: Build a bridge between Stivarga and first-line blockbuster Nexavar. And now, the company’s ready to move into Phase 2: Dominate the market.
Thursday, the FDA green-lighted Stivarga as a second-line treatment for patients with unresectable forms of the disease. The approval follows results that showed Stivarga was the first drug to post an overall survival advantage in the population, earning the med the agency’s priority tag.
Now, Bayer’s counting on the approval create a link between its two therapies that the German drugmaker thinks will help it run the table in liver cancer.
“We know that there are other drugs being studied in this area, but those would be one-off approvals—front line, second line—but not necessarily this continuum approach that we could actually offer physicians as they think about the totality of treatments for the patients,” company oncology head Robert LaCaze told FiercePharma at October’s European Society for Medical Oncology annual meeting.
Stivarga, which Bayer counts among its Big 5 growth meds, hasn’t always performed like one in recent months. It closed out 2016 with €275 million in sales, marking a 12.1% decline from its 2015 sales haul of €313 million—and failing to come close to the 28%-plus expansion percentages fellow growth meds Xarelto, Eylea and Xofigo put up for the year.
The reason? “Intensified competition in the U.S.” from Otsuka’s Lonsurf, which has made things difficult for Stivarga on the colorectal cancer front.
In Q1, though, Stivarga showed signs of life, turning in a €75 million performance that beat out the year-ago period by 11.9% and just edged out consensus of €74 million. And the new liver cancer nod should only help things improve from there—the malady is the sixth most common cancer worldwide, and the second leading cause of global cancer-related deaths, Bayer said.