- The Food and Drug Administration has granted a breakthrough therapy designation to Imbruvica (ibrutinib), a cancer drug co-marketed by Johnson & Johnson and AbbVie, for second-line treatment of chronic graft-versus-host disease.
- Imbruvica is currently indicated for three types of blood cancer: relapsed or refractory mantle cell lymphoma, Waldenström's macroglobulinemia and chronic lymphocytic leukemia.
- Corticosteroids are typically used as first-line treatment for graft-versus-host disease (GVHD). But once that fails, there are no approved second-line treatment options.
This is the fourth breakthrough designation for Imbruvica, and also sets up the drug for a potential expansion beyond treatment of blood cancer into GVHD—a condition that can occur in patients who have undergone stem-call or bone marrow transplantation. In GVHD, the patient's body is attacked by donor immune cells.
"We are excited to learn if the mechanism of action for ibrutinib may allow its use beyond its current indications in hematologic malignancies," said Sen Zhuang, vice president for clinical development, hematology at Janssen's R&D division.
Since approval in November 2013, Johnson & Johnson (the parent company of Janssen) has watched sales of Imbruvica grow.
AbbVie gained access to the drug when it bought Pharmacyclics for $21 billion last year. AbbVie predicts blockbuster status for Imbruvica, and $5 billion in sales by 2020.