FDA approves Imbruvica (ibrutinib) for MCL

Share this article:
J&J cancer med adds indication, lower dose
J&J cancer med adds indication, lower dose

The FDA approved Pharmacyclics/Janssen's mantle cell lymphoma drug Imbruvica Wednesday. This was one of the early drugs to receive the FDA's breakthrough therapy designation to help speed it through the review process.

Roche's Gazyva, approved last week, was the first breakthrough-status drug to get approved. It's indicated for chronic lymphocytic leukemia.

Johnson & Johnson estimates that the breakthrough label has shaved two years off development for ibrutinib, as noted by Reuters earlier this summer.

Imbruvica was also granted breakthrough therapy status for CL/small lymphocytic lymphoma with deletion of the short arm of chromosome 17 and Waldenstrom's macroglobulinemia.

Share this article:

Email Newsletters

More in News

Star Group merges with Vox Medica, Calcium NYC

Star Group merges with Vox Medica, Calcium NYC

The newly formed group will be known as Calcium with Steve Michaelson, formerly of Rosetta Wishbone, at the helm.

Survey finds pay doesn't make doctors happy

Survey finds pay doesn't make doctors happy

Medscape's survey of over 24,000 physicians found that a paycheck is not necessarily linked to a physician's professional satisfaction.

CDC sees declines in some diabetes complications

CDC sees declines in some diabetes complications

Centers for Disease Control data shows that diabetes complications including heart attack and amputation fell in the twenty years between 1990 and 2010. The bad news: the number of diagnosed ...