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John Theurer Cancer Center Announces Positive Results from Revlimid MCL-001(EMERGE) Study Leading to FDA Approval of First Oral Therapy for Refractory Mantle-Cell Lymphoma (MCL) Patients
Date:9/26/2013

with MD Anderson Cancer Center and a number of institutions around the world. This study reported the impressive activity of the first BTK (Bruton's Tyrosine Kinase) inhibitor called PCI-32765 or ibrutinib. Ibrutinib belongs to a new category of drugs targeting the BCR (B-cell receptor) pathway, which appears very critical for B-cells and lymphoma cells' survival. Ibrutinib was very well tolerated and showed activity in almost three-fourths of the patients with very durable responses. Ibrutinib is currently under priority review by the FDA as an additional therapeutic treatment option. ("Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma" NEJM August 2013).

"These two new drugs represent great hope for patients with relapsed/refractory mantle-cell lymphoma and offer a terrific opportunity moving forward for treatments in combination or after conventional chemotherapy (as maintenance or consolidation), which will definitely improve the outcome of mantle-cell lymphoma patients," said Andre Goy, M.D., M.S.

Dr. Goy previously showed the first activity of bortezomib (proteasome inhibitor) and headed the trials which led to bortezomib approval as the first new drug ever approved by the FDA for relapsed/refractory mantle cell lymphoma.

"As one of the premier Lymphoma programs in the nation, we are committed to being at the forefront of cutting-edge research and treatment," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chief Innovations Officer, Professor and Vice President of Cancer Services, John Theurer Cancer Center and President of Regional Cancer Care Associates. "MCL-001 and the approval of lenalidomide represent a breakthrough in the treatment of mantle-cell lymphoma."

About John Theurer Cancer Center at Hackensack University Medical Center
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