Celgene Corporation
Jun 16, 2011
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FDA Grants Accelerated Approval of ISTODAX® As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy

SUMMIT, N.J., Jun 16, 2011 (BUSINESS WIRE) --

Celgene Corporation (Nasdaq:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for its Supplemental New Drug Application (sNDA) for an additional indication for ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. ISTODAX is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

The PTCL approval was based on a priority (6 month) review by the FDA. Priority reviews are reserved for serious and life-threatening conditions that have an unmet medical need.

The ISTODAX sNDA approval is based upon results from two studies, a Phase II, multicenter, international, open-label, single-arm study of ISTODAX in patients with PTCL who had failed at least one prior systemic therapy (Study 3), which was presented at the 2010 American Society of Hematology annual meeting, and a single-arm clinical study of ISTODAX in patients with PTCL who had failed prior therapy (Study 4).

About ISTODAX

ISTODAX® (romidepsin) for injection is an epigenetic therapy and a member of a class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, ISTODAX causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized. For full prescribing information, visit www.ISTODAX.com.

ISTODAX® (romidepsin) for injection is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

ISTODAX® (romidepsin) for injection is indicated for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

Important Safety Information

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

Peripheral T-Cell Lymphoma

Cutaneous T-Cell Lymphoma

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see full Prescribing Information, including WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS.

ISTODAX® (romidepsin) for injection is indicated for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. This indication is based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

About PTCL

Peripheral T-cell lymphoma comprises a heterogeneous group of malignancies of T-cell origin that account for about 10-15% of all cases of non-Hodgkin's lymphoma. PTCL can occur from young adulthood to old age and is slightly more common in men than in women. It is a particularly aggressive form of lymphoma with a short median duration of survival (approximately two years) from diagnosis.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company's Web site at www.celgene.com.

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 10K, 10Q and 8K reports.

SOURCE: Celgene Corporation

Celgene Corporation
Jacqualyn A. Fouse, 908-673-9956
Sr. Vice President and
Chief Financial Officer
or
Brian Gill, 908-673-9530
Vice President,
Corporate Communication