Pharmacyclics, Roche deal

The companies partnered to evaluate Imbruvica ibrutinib in combination with Gazyva obinutuzumab in a Phase III trial conducted by Pharmacyclics to treat chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). The partners will later evaluate a combination to treat non-Hodgkin Lymphoma (NHL). Roche declined to provide details, and Pharmacyclics could not be reached.

Imbruvica, a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481, has full approval in the U.S. for first-line therapy for chronic lymphocytic leukemia (CLL) in patients with chromosome 17p deletion and to treat CLL in patients who have received at least one prior therapy. It has accelerated approval from FDA to treat mantle cell lymphoma (MCL) in patients who have received at least one prior therapy. The drug also has Orphan Drug designation in the EU for diffuse large B cell lymphoma (DLBCL) and follicular lymphoma and in the U.S. for DLBCL. It has breakthrough therapy status from FDA for MCL and for CLL or small lymphocytic leukemia (SLL) in patients with chromosome 17p deletion. Pharmacyclics is co-developing and co-commercializing ibrutinib with the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) under a 2011 deal (see BioCentury, Dec. 12, 2011 & Aug. 4, 2014). ...