“We fully support the FDA accelerated approval pathway, which patients rely on for timely access to promising treatments that may improve or extend their lives. While withdrawing these indications was a difficult decision, we remain confident in the benefit/risk profile of IMBRUVICA in its approved indications and are committed to its continued development,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “IMBRUVICA has transformed how patients with B-cell malignancies are treated and is the most comprehensively studied and prescribed therapy in its class.”
