Celgene International Sàrl (Nasdaq:CELG) today announced the publication of peer–reviewed data from a Phase II study of REVLIMID in relapsed or refractory aggressive non–Hodgkin´s lymphoma in the Journal of Clinical Oncology. According to the data, REVLIMID, as an oral monotherapy, demonstrated activity in patients at an advanced stage of the disease who had received a median of four prior treatments and had limited treatment options.
According to the publication, of 49 patients eligible for response evaluation in the study, an objective response was observed in 35 percent, with 12 percent exhibiting a complete or unconfirmed complete response. Activity was also seen in other lymphoma subtypes, including diffuse large b–cell, follicular grade 3 and transformed.
In the study, the most common grade 4 adverse events were neutropenia (8.2%) and thrombocytopenia (8.2%) and the most common grade 3 adverse events were neutropenia (24.5%), leukopenia (14.3%) and thrombocytopenia (12.2%).
"These peer–reviewed data continue to show that oral therapy REVLIMID is active in relapsed or refractory NHL with manageable side effects," said Peter H. Wiernik, MD, Director, Cancer Center, Montefiore Medical Center–North Division and lead author of the study. "These results also suggest that the activity of REVLIMID is applicable to patients with aggressive disease who have few treatment options open to them."
REVLIMID is currently approved in the United States, the EU, Australia, Venezuela, Argentina and Switzerland for treatment of patients with multiple myeloma in combination with dexamethasone who have received at least one prior therapy. REVLIMID is also approved in the United States, Canada, Venezuela and Argentina for transfusion–dependent anemia due to low– or intermediate–1–risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia.
About REVLIMID®
REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition–of–matter and use patents.
About Non–Hodgkin´s Lymphoma
Lymphoma is the name for the group of blood cancers that start in the lymphatic system, which is part of the body´s immune system. Lymphomas generally start in the lymph nodes or lymphatic tissue in sites of the body such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. Most people with lymphoma have one of the many different kinds of non–Hodgkin´s lymphoma (NHL) and there are an estimated 360,000 cases of NHL in the U.S. with more than 59,000 new cases diagnosed annually.
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company´s website at www.celgene.com.
REVLIMID® and IMiDs® are registered trademarks of Celgene Corporation.
This release contains certain forward–looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company´s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward–looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company´s filings with the Securities and Exchange Commission such as Form 10–K, 10–Q and 8–K reports.
