J&J, AbbVie's Imbruvica breaks out of blood-cancer corner with new graft-versus-host approval

Imbruvica already bears FDA approvals in chronic lymphocytic leukemia, previously treated mantle cell lymphoma and Waldenström macroglobulinemia.

AbbVie may have shelled out a whole lot of money to gain access to Imbruvica, but the med keeps paying off.

On Wednesday, the FDA approved the product for chronic graft-versus-host disease (cGVHD), marking the first time it’s greenlighted any med in that area. Imbruvica bears a second-line nod, meaning patients need to have failed on one or more treatmentssuch as corticosteroidsbefore receiving it.

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The med took an expedited trip through the regulatory review process, helped by the FDA’s breakthrough therapy and orphan drug designations. And Imbruvica doesn’t really know any other kind of trip. The cGVHD breakthrough was its fourth; it had previously won the distinction in chronic lymphocytic leukemia (CLL), previously treated mantle cell lymphoma (MCL) and Waldenström macroglobulinemia.

That potential was part of what convinced AbbVie to drop a cool $21 billion on Pharmacyclics, which developed the drug alongside Johnson & Johnson. At the time, analysts called the sum “staggering” and “astronomical,” but company CEO Richard Gonzalez stood by Imbruvica’s potential to rack up $7 billion in peak sales for the Illinois drugmakerand that’s not to mention the sales going to J&J.

Whether it can hit that target remains to be seen; Wall Street has been pegging its estimates below AbbVie’s own forecast of $5 billion in 2020 revenues, Leerink Partners analyst Geoffrey Porges wrote to clients last week, as the product has posted “frequent quarterly revenue misses in the past.” Last week, though, AbbVie said Imbruvica had delivered $528 million in second-quarter sales, a 16% jump over the year-ago quarter.

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Wednesday’s approval was also the med’s first outside of the blood cancer arenaan encouraging sign for its makers, who will soon be facing ramped-up competition. Earlier in the day, AstraZeneca said that U.S. regulators had accepted its application for BTK inhibitor acalabrutinib in relapsed/refractory MCL patients just one day after handing it a breakthrough tag of its own. And the British drugmaker is currently running a phase 3, head-to-head CLL trial pitting that candidate against Imbruvica.

“In previous-reported trials, acalabrutinib appears to be more tolerable than Imbruvica, with lower rates of atrial fibrillation and major hemorrhage,” Porges’ Leerink colleague Seamus Fernandez wrote to clients Wednesday. But “it remains to be seen if these differences hold up” in the ongoing phase 3 study, he noted.