J&J's Imbruvica bests Glaxo's Arzerra in CLL trial, raising hopes for off-label sales

While some analysts have tabbed Johnson & Johnson ($JNJ) and Pharmacyclics' ($PCYC) Imbruvica as a future multibillion-dollar blockbuster, it currently boasts only one approval--for mantle cell lymphoma (MCL), a rare disease. But positive data from a new trial in chronic lymphocytic leukemia (CLL) should open up some doors for the drug, as analysts expect to see an uptick in off-label use.

As PMLiVE reports, an independent panel stopped short a trial comparing Imbruvica with GlaxoSmithKline's ($GSK) Arzerra as a second-line treatment for CLL after Imbruvica showed significant improvement in both progression-free survival and overall survival. And while details on the survival impact aren't yet available, Imbruvica's edge was enough to convince the trial's monitoring committee to advise that all patients in the Arzerra arm be granted access to Imbruvica.

And that edge could also lead doctors to prescribe Imbruvica off-label for CLL, Forbes notes. "With the positive data, we expect the off label use of Imbruvica in CLL to increase," Deutsche Bank analyst Robyn Karnauskus wrote in a note seen by Forbes. As Karnauskus estimates, 35% of Imbruvica use is already for CLL.

Meanwhile, J&J and Pharmacyclics are waiting for the FDA to decide about a new use for Imbruvica in CLL patients, with the agency's answer expected by the end of February. And while Karnauskus pointed out that adding the new study data to the application could actually stall that process, she believes the off-label spike should offset any regulatory delays.

But for underwhelmed Pharmacyclics shareholders, that approval can't come soon enough. As Sanford Bernstein analyst Geoffrey Porges wrote in a Monday note on the company, Imbruvica's current indication as a second-line MCL treatment is "somewhat limiting so far." And while Porges expects Imbruvica "will dominate this niche market," achieving 85% penetration in the patient population, it's still, after all, a niche market. According to Forbes, though shares of the company jumped 18% to $123.90 on news of the recent study, they've still slid 10% overall after peaking in October.

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