AbbVie (ABBV) Files SNDA For Blood Cancer Drug Imbruvica
Zacks Investment Research | Sep 26, 2016 10:14PM ET
AbbVie Inc. (NYSE:ABBV) announced the submission of a supplemental New Drug Application (sNDA) for its blood cancer drug Imbruvica (ibrutinib) in the U.S.
AbbVie is looking for a label expansion of Imbruvica to include the treatment of marginal zone lymphoma (MZL). MZL is a slow-growing form of non-Hodgkin's lymphoma.
Imbruvica is currently approved in the U.S. for the treatment of patients with MCL or CLL who have received at least one previous therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia. This is the fifth time that AbbVie has filed an sNDA for Imbruvica.
Pharmacyclics LLC, a subsidiary of AbbVie, markets Imbruvica under a partnership with Johnson & Johnson’s (NYSE:JNJ) Janssen Biotech, Inc.
The sNDA was based on data from a multi-center, open-label phase II PCYC-1121-CA trial assessing Imbruvica as a single-agent treatment for MZL. The study enrolled 63 previously treated patients with MZL. Patients were received once-daily oral administration of ibrutinib alone. The primary endpoint of the overall response rate as assessed by an Independent Review Committee was met.
We remind investors that in Apr 2013, the FDA had granted Breakthrough Therapy designation to ibrutinib for the treatment of CLL/small lymphocytic lymphoma patients, with a deletion of chromosome 17p. Earlier this year, the regulatory agency granted Breakthrough Therapy designation to ibrutinib for the treatment of mantle cell lymphoma patients as monotherapy. The FDA granted also granted Breakthrough Therapy status to the candidate for the treatment of patients suffering from Waldenström's macroglobulinemia as monotherapy. We expect investor focus to remain on the further development of ibrutinib.
AbbVie expects Imbruvica peak sales of over $7 billion and revenues of about $5 billion in 2020. We believe Imbruvica has multi-billion dollar potential and AbbVie is working on expanding Imbruvica’s label to include solid tumors and autoimmune diseases. The company sees Imbruvica as a “pipeline in a molecule” given that the treatment is presently in several company-sponsored studies. A registrational study for graft-versus-host disease is underway, with data expected later this year or early 2017.
We remind investors that Imbruvica was added to AbbVie’s portfolio following its Pharmacyclics acquisition in May 2015.
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