Imbruvica, Rituxan Combination sNDA Accepted for Review by FDA

AbbVie announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia (WM), a rare and incurable form of blood cancer. If approved, the sNDA would expand the prescribing information of Imbruvica in WM beyond its current approved use as a single agent for all lines of therapy to include combination use with rituximab. As a single-agent therapy, Imbruvica is the first and only FDA-approved treatment available for patients with WM. Imbruvica is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.

"We are excited about the data from the Phase 3 iNNOVATE study, which indicate that Imbruvica plus rituximab was able to improve progression-free survival, versus rituximab alone, across all lines of therapy and Waldenström's macroglobulinemia patient subgroups that were studied," said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics, an AbbVie company. "These promising findings build on our commitment to exploring the full potential of Imbruvica alone and in combination with other treatments. If approved, this chemotherapy-free combination will provide another treatment opportunity for patients living with this rare disease, which continues to have very limited treatment options."

The sNDA is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial assessing Imbruvica in combination with rituximab, versus rituximab alone, in patients with previously untreated and relapsed/refractory WM.

Waldenström's macroglobulinemia is a rare and incurable form of non-Hodgkin's lymphoma (NHL). There are about 2,800 new cases of WM in the U.S. each year. In January 2015, IMBRUVICA received FDA approval for all lines of treatment in WM and as the first and only FDA-approved therapy specifically indicated for this disease.