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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...