Janssen’s leukemia drug receives third FDA breakthrough therapy designation

Hannah Blake

pharmaphorum

Janssen and Pharmacyclics have announced that the US FDA has granted a third Breakthrough Therapy Designation (BTD) for their joint investigational oral agent ibrutinib. The FDA awarded the drug with its first two BTD’s back in February 2013.

Ibrutinib is a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (del 17p).

The FDA designation is intended to speed up the development and review of a potential new drug for serious or life-threatening diseases when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

“Ibrutinib continues to demonstrate promise for patients living with B-cell malignancies, and we are pleased that the FDA has recognized its potential for people living with CLL and the del17p mutation. This third Breakthrough Therapy Designation reflects the potential importance of ibrutinib for patients diagnosed with a 17p deletion chromosomal abnormality in CLL/SLL, and we are committed to working with Pharmacyclics and the FDA to expedite development and review of ibrutinib as quickly as possible.”

Peter F. Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen.

Chronic lymphocytic leukemia is the second most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with this cancer.