07/06/2022
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.
