Impressive Results from ibrutinib Study Conducted at John Theurer Cancer Center Lead to FDA Approval of Imbruvica as a Single Agent for Patients with Mantle Cell Lymphoma

John Theurer Cancer Center Chairman and Lymphoma Chief Andre Goy, M.D., M.S., Responsible for Leading Research Efforts that Result in New Treatments and New Hope for MCL Patients

HACKENSACK, N.J.--()--Andre Goy, M.D., M.S., Chairman and Director of John Theurer Cancer Center and Chief of the Lymphoma Program, announced today that ibrutinib, to be marketed as Imbruvica, has been approved by the FDA based on clinical studies conducted at John Theurer Cancer Center in previously treated mantle cell lymphoma patients. Imbruvica becomes the first-in-class of drugs targeting the B-cell receptor pathway. Approval of Imbruvica was granted under breakthrough therapy designation based on the strong positive results demonstrated in the clinical trial.

“This is one of the most transforming advances in the treatment of cancer. It provides a new treatment option that has the potential to greatly improve the lives of mantle cell lymphoma patients,” said Andre Goy, M.D., M.S. “Imbruvica further demonstrates the shift ‘away from chemotherapy’ that is already emerging in hematological malignancies particularly in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) patients.”

Mantle cell lymphoma is an aggressive blood cancer that starts in the white blood cells and accounts for about six percent of all non-Hodgkin lymphoma cases in the U.S., according to the FDA. The disease affects fewer than 200,000 people in the U.S. with about 2,900 new cases diagnosed each year. By the time it is diagnosed, the cancer usually has spread to the lymph nodes, bone marrow and other organs.

Imbruvica is an orally bioavailable agent very well tolerated with minimal hematological toxicity, allowing new opportunities in the combination setting. It is intended for patients with MCL who have received at least one prior therapy and works by inhibiting the enzyme needed by the cancer to multiply and spread. While two other drugs are available to treat MCL, Imbruvica is the first drug approved to treat MCL under breakthrough therapy designation by the FDA, and the second approval by the FDA under this category. The Food and Drug Administration Safety and Innovation Act, passed in July 2012, is designed to speed up development of promising drugs by providing increased and earlier communication with FDA scientists.

Imbruvica has shown impressive activity early on across B-cell malignancies including diffuse large B-cell lymphoma (DLBCL ABC subtype), chronic lymphocytic leukemia (CLL), Waldenstrom Macroglobulinemia (WM) and particularly mantle cell lymphoma (MCL), which has led to three breakthrough designations by the FDA in a matter of months.

Results from the ibrutinib study conducted at John Theurer Cancer Center in collaboration with MD Anderson Cancer Center and a number of institutions around the world were published in the New England Journal of Medicine in August. The 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. (“Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma” NEJM August 2013).

Dr. Goy, an international expert in the field, previously showed the first activity of bortezomib (proteasome inhibitor) as principal investigator for the trials which led to bortezomib’s approval as the first new drug ever approved by the FDA for relapsed/refractory mantle cell lymphoma. Bortezomid is marketed as Velcade®. Dr. Goy was also lead author of the MCL-001 study, which led to FDA approval earlier this year of lenalidomide, marketed as Revlimid®, to treat patients with mantle cell lymphoma who have relapsed or whose disease has progressed after two prior therapies including at least one prior treatment with bortezomib. Previously, Temsirolimus, marketed as Torisel, was approved for use in Europe.

“Our researchers continue to shape the future of cancer care through clinical trials such as this one,” 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. “Our center reflects a future where a cure for cancer will be a reality and continues to be committed to providing patients hope through leading edge research and the development of new treatment options.”

About John Theurer Cancer Center at Hackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is among the nation’s top 50 U.S. News and World Report Best Hospitals for cancer – the only ranked in New Jersey with this designation. It is New Jersey's largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.

Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertise—all under one roof. Physicians at John Theurer Cancer Center are members of Regional Cancer Care Associates one of the nation’s largest professional hematology/oncology groups. For more information please visit www.jtcancercenter.org.

About Regional Cancer Care Associates

Regional Cancer Care Associates (RCCA), one of the largest oncology physician networks in the US, is transforming oncology care by ensuring patients and their caregivers are an active part of the treatment team in all aspects of the management of their disease in a way that is life-enriching and respectful.

Regional Cancer Care Associates extends across New Jersey with more than 90 cancer care specialists, growing to include more than 100, and is supported by 700 employees at 27 care delivery sites, providing care to more than 20,000 new patients annually and over 230,000 existing patients. RCCA takes responsibility to ensure access to the highest quality, compassionate and cutting-edge cancer care for its patients while controlling the cost of this care. For more information visit: www.regionalcancercare.org.

Contacts

John Theurer Cancer Center
Jon Byington, 212-601-8208
jtcc@porternovelli.com

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Impressive Results from ibrutinib Study Conducted at John Theurer Cancer Center Lead to FDA Approval of Imbruvica as a Single Agent for Patients with Mantle Cell Lymphoma

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Contacts

John Theurer Cancer Center
Jon Byington, 212-601-8208
jtcc@porternovelli.com