ASH: Can Johnson & Johnson sell regulators on Xarelto as clot prevention for cancer patients?

Johnson & Johnson's clot-busting Xarelto may not have hit the primary goal in its latest trial, but the company still believes it can win a new approval down the line—and as the drug's laundry list of current indications shows, J&J knows how to expand its reach.

On Tuesday at the American Society of Hematology annual meeting, the New Jersey drugmaker said Xarelto had fallen short of statistical significance in its quest to prove it could outdo placebo at preventing blood clots in high-risk cancer patients.

The company, however, was quick to point to a "good, strong trend" in favor of Xarelto, as Paul Burton, M.D., Ph.D., VP of medical affairs at J&J’s Janssen, put it. Deep vein thrombosis, pulmonary embolism or death related to venous thromboembolism (VTE) occurred in 5.95% of patients treated daily with a 10-mg dose of Xarelto, versus 8.79% of those in the placebo arm—good for a 34% relative risk reduction.

One reason Xarelto may not have hit its statistical target? About 40% of patients stopped taking the drug during the trial. And when J&J removed those patients in a separate analysis, results were "highly significant," Burton said.

"When you analyze the patients while they were actually taking the drug, which makes the most clinical sense, you see a 60% reduction in risk," he pointed out, adding, "We definitely want to talk to regulators, talk to FDA about the data and look at the path forward."

J&J is looking to make Xarelto the first FDA-approved drug for clot prevention in patients with cancer, who face a higher risk of blood clots. A VTE episode "derails their surgery, their radiotherapy, their chemotherapy and so on," Burton said. Overall, it's the second most common cause of death in cancer patients.

And if J&J can sell regulators on Xarelto's results, its new patient pool could be a large one, especially as new therapies continue to extend the lives of cancer patients.

One thing is clear: The company would welcome the boost. It’s worked hard to rack up a slew of indications for Xarelto, including an October OK in artery disease that could pad sales by $1.5 billion. In atrial fibrillation, though, it’s still losing share to Pfizer and Bristol-Myers Squibb’s Eliquis, which has come from behind to take the lead in the class of next-generation oral anticoagulants.

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