Priority Review for Pharmacyclics' ibrutinib
FDA accepted and granted Priority Review to an NDA from Pharmacyclics Inc. (NASDAQ:PCYC) for ibrutinib to treat relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL). The PDUFA date is Feb. 28, 2014. The acceptance triggers a $75 million milestone payment to Pharmacyclics from the Janssen Biotech Inc. subsidiary of Johnson & Johnson (NYSE:JNJ) under their 2011 deal.
The Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 has breakthrough therapy designation from FDA for MCL and for CLL or SLL in patients with chromosome 17p deletion, as well as for Waldenstrom's macroglobulinemia. Jay Siegel, head of global regulatory affairs for Janssen R&D, discussed ibrutinib and the breakthrough designation program during an interview in June with BioCentury This Week television (see BioCentury This Week, June 30). ...