US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

The US Food and Drug Administration yesterday (November 13) approved US health care giant Johnson & Johnson’s (NYSE: JNJ) Imbruvica (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL), a rare blood cancer, who have received at least one prior therapy.

This indication is based on overall response rate (ORR); an improvement in survival or disease-related symptoms has not been established. Imbruvica is one of the first drugs to receive FDA approval via the Breakthrough Therapy Designation pathway, which is intended to speed up the development and review of treatments to help address serious or life-threatening diseases.

Imbruvica is the third drug approved to treat MCL. Velcade (bortezomib, from Millennium and approved in 2006) and Revlimid ((lenalidomide, from Celgene approved in 2013) are also cleared to treat the disease, says the FDA. The drug is still under review by the European Medicines Agency.

Developed with Pharmacyclics