US FDA grants approval for Imbruvica for chronic lymphocytic leukemia

The US Food and Drug Administration has granted USA-based Pharmacyclics (Nasdaq: PCYC) approval for Imbruvica (ibrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment naive and previously treated del 17p CLL patients.

Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of US health care giant Johnson & Johnson (NYSE: JNJ). The deal with Janssen involved $150 million upfront and further potential payments of $825 million to Pharmacyclics. This approval for Imbruvica triggers $60 million in milestone payments to Pharmacyclics under the collaboration.

This is the first full FDA approval for Imbruvica, and was granted within six months after the accelerated approval for patients with previously treated CLL in February 2014. Imbruvica had received the Breakthrough Therapy Designation for patients with del 17p CLL in April 2013.