U.S. regulators have stamped an approval as expected on Sanofi ($SNY) and Regeneron's ($REGN) drug Zaltrap for patients with aggressive cases of colorectal cancer. The FDA's approval includes a boxed warning that the drug can trigger serious and at times fatal bleeding, slow wound healing and lead to holes in the gastrointestinal tract.
Though Zaltrap isn't expected to be a blockbuster, Sanofi's approval bolsters the Paris-based pharma giant's mission to usher new drugs to market as its major sellers such as the blood thinner Plavix face generic drug competition. And the fact that Zaltrap comes from partner Regeneron supports Sanofi CEO Chris Viehbacher's case for generating more R&D productivity at the company through a constellation of alliances. Even as Sanofi and partner Regeneron celebrate this regulatory victory, Sanofi is expected to cut a bunch of research jobs through the layoffs of some 2,500 workers in France.
The FDA green-lighted Zaltrap for use in combination with a certain chemotherapy regimen called Folfiri for colorectal cancer patients whose tumors are spreading and have built resistance to chemo with oxaliplatin. Regulators judged the new drug based in large part on the results of a key study in which patients in the Zaltrap arm lived for 1.5 months longer than those taking Folfiri chemo and placebo. Patients on the Zaltrap-containing regimen also lived 2.2 months longer without their cancer spreading than patients in the placebo arm.
As U.S regulators noted in their approval release, colorectal cancer will kill an estimated 51,690 Americans this year and the tumors are the country's fourth most common cause of cancer deaths.
Zaltrap, which has failed to impress in a series of trials for prostate cancer and other tumors, will rival Roche's ($RHHBY) similar drug Avastin and Bristol-Myers Squibb's ($BMY) Erbitux. As reported in The Financial Times earlier this week, there are no head-to-head data on the two drugs yet at least one cancer specialist noted that Zaltrap could be a more potent VEGF inhibitor than Roche's drug.
- here's the FDA's release
- see Reuters' update
- check out Forbes' Matthew Herper's take
Special Reports: Sanofi - The Biggest R&D Spenders In Biopharma | Zaltrap - Top 10 Late-Stage Cancer Drugs 2012
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