Bayer's struggling Stivarga moves closer to liver-cancer lifeline with FDA 'priority' tag

The FDA has granted Bayer's Stivarga its priority review designation in second-line liver cancer.

Bayer cancer med Stivarga has been grappling with some new colorectal cancer competition—but a new indication may be on the way soon to give it a boost.

On Wednesday, U.S. regulators granted the med their “priority” tag for second-line liver cancer treatment, meaning the drug could zip down the regulatory pathway to a green light in six months. And if it does, Bayer is confident it will be able to top the liver cancer market well into the future by building a bridge between Stivarga and first-line blockbuster Nexavar.

“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.

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Either way, Bayer will run the second-line unresectable liver cancer show in the near term with a Stivarga approval; it’s the first drug to show an overall survival advantage in that population. And it’s no small population, either: Liver cancer is the second-largest killer among cancer patients, with more than 600,000 patients per year succumbing to the disease.

Stivarga could certainly use a revenue lift. Through the first nine months of 2016, sales of the med “receded noticeably due to intensified competition in the U.S.,” the German drugmaker has said. The cancer-fighter posted a top-line haul of just $198 million, 16.1% short of its tally through the first three quarters of 2015. In the U.S. alone, the damage was even worse: With Otsuka’s Lonsurf arriving on the scene in October 2015, Stivarga sales crashed 27.5% through 2016’s first three quarters to $100 million.

That’s not going to cut it for a product Bayer sees as one of its top five growth prospects. In September, new CEO Werner Baumann—working to allay investor concerns over Bayer’s mammoth Monsanto buy—increased the company’s sales forecast for the group—which comprises Stivarga, fellow cancer med Xofigo, next-gen anticoagulant Xarelto, eye blockbuster Eylea and pulmonary arterial hypertension therapy Adempas—to more than €10 billion, up from a previous €7.5 billion-target.


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