Imbruvica ibrutinib regulatory update

FDA granted accelerated approval to Imbruvica ibrutinib from Pharmacyclics and partner Johnson & Johnson to treat chronic lymphocytic leukemia (CLL) in patients who have received >=1 prior therapy. The approval - which triggered a $60 million milestone payment to Pharmacyclics from J&J - was based on data from a Phase Ib/II trial showing the drug led to an overall response rate (ORR) of 58.3% in 48 patients with relapsed or refractory CLL or small cell lymphocytic lymphoma (SLL). Pharmacyclics had been seeking approval for both CLL and SLL, but according to the company, FDA said data for the 3 SLL patients in the trial was "too small to make a conclusion about efficacy." The company said it will decide next steps for the SLL indication once it has data from the ongoing Phase III trials. Imbruvica already has accelerated approval from FDA for relapsed or refractory mantle cell lymphoma (MCL) in patients who have received >=1 prior therapy. Pharmacyclics and J&J have not yet broken out sales of the drug, which the partners launched in November (see BioCentury, Nov. 18, 2013). ...