Newest Imbruvica 'breakthrough' tag gives J&J, AbbVie hope for expansion outside blood cancers


Johnson & Johnson and AbbVie have been charging hard to rack up additional indications for star med Imbruvica in hematologic cancers. But with the med’s latest breakthrough designation, there’s hope for the pair expanding Imbruvica’s patient pool outside that area, too.

Wednesday, U.S. regulators granted both their breakthrough tag and an orphan drug designation to Imbruvica as a second-line treatment for chronic graft-versus-host disease--moves that’ll put the product on a speedy path to an FDA thumbs-up. Right now, there are no approved meds or established standards of care specifically geared toward cGVHD patients who have failed their first-line treatment, the companies noted.

The breakthrough win--No. 4 for Imbruvica, which currently boasts indications in chronic lymphocytic leukemia (CLL), previously treated mantle cell lymphoma (MCL) and Waldenström macroglobulinemia--“shows the promise of Imbruvica and its unique mechanism of action as a potential therapy beyond blood cancers,” Danelle James, head of oncology at AbbVie’s Pharmacyclics, said in a statement.

AbbVie, for one, would like nothing more than an additional boost as it works to hit $7 billion in peak sales--and that’s not including what J&J takes in for its share. CEO Richard Gonzalez outlined the goal last March after agreeing to shell out $21 billion on Pharmacyclics--a price analysts deemed “lofty,” “staggering” and even “astronomical.”

So far, though, the therapy has been living up to expectations. In March, it snagged an FDA green light in treatment-naïve CLL patients, opening it up as an option for a larger group of patients who stay on therapy for longer periods of time. Moving up in the treatment sequence is how Imbruvica will post nearly a third of its forthcoming growth, Gonzalez said at the time of the deal announcement.

- read J&J's release
- read AbbVie's release

Special Report: Top 20 orphan drugs by 2018 - Ibrutinib

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