FDA Approves New indication For Imbruvica
On February 12, 2014 the U.S. Food and Drug Administration approved a new indication for Imbruvica (chemical name ibrutinib). The drug is now approved to treat patients with chronic lymphocytic leukemia (CLL). Imbruvica was initially approved by the FDA on November 13, 2013 with an indication to treat mantle cell leukemia (MCL), a rare and aggressive form of blood cancer, in patients who have been treated with at least one other therapy.
Imbruvica is an oral Bruton’s tyrosine kinase inhibitor that is supplied as 140 mg capsules. The recommended dose for CLL is 420 mg once daily. This compares to a recommended dose of 560 mg daily for MCL.
Efficacy and safety for Imbruvica’s CLL indication was established in a single clinical trial under the FDA’s accelerated review process, which allows approval based on observed response in intermediate endpoints. Common side effects observed in the clinical trial that gained the CLL indication included thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory tract infection, fatigue, musculoskeletal pain, rash, fever, constipation, peripheral edema, arthralgia, nausea, stomatitis, sinus infection and dizziness.
Imbruvica is manufactured in the U.S. by Pharmacyclics, Inc. and the estimated cost to treat CLL will be approximately $9,800 per month.
For more information, see the Imbruvica information on the manufacturer’s website at Pharmacyclics, Inc. or the FDA’s news release at: FDA Imbruvica Announcement