J&J's Imbruvica snares fourth indication
Johnson & Johnson's Imbruvica (ibrutinib) now has an expanded label. The FDA announced Thursday that the drug, made with J&J partner Pharmacyclics, can now include an indication for Waldenstrom's macroglubulinemia, a rare form of non-Hodgkin lymphoma.
Thursday's news builds on the previous indications, which include mantle cell lymphoma, chronic lymphocytic leukemia — known as CLL—and CLL with a 17p deletion.
Like these other indications, the Waldenstrom application carried the regulator's Breakthrough Therapy label, which helped expedite approval. Johnson & Johnson estimated in 2013 the Breakthrough label shaved two years off its development. Imbruvica wrangled $92 million in fourth-quarter sales and $200 million for the year.
The Breakthrough Therapy approval process, which pushes a drug into a 60-day review period, started in 2012. The regulator approved three BT drugs in 2013. Cancer drugs dominated last year's total, accounting for four of the nine Breakthrough drug approvals which included Merck's Keytruda (pembrolizumab) and Gilead's Zydelig (idelalisib).