SEATTLE, Nov. 17, 2010 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) reviewed the impact of labeled and unlabeled use of PROVENGE® (sipuleucel-T) treatment on health outcomes of patients with advanced prostate cancer. This panel was convened as a part of the National Coverage Analysis (NCA) that was initiated by the Centers for Medicare and Medicaid Services (CMS).
"PROVENGE is an important new treatment for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer. "We look forward to working closely with CMS throughout the NCA process to ensure patients with advanced prostate cancer have access to PROVENGE."
PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies and is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. On June 30, 2010, CMS initiated the NCA of PROVENGE. According to CMS, a draft guidance memo will be issued by March 30, 2011, and the expected NCA completion date is June 30, 2011.
The NCA does not impact existing coverage decisions, nor does it restrict local Medicare Administrative Contractors (MACs) from covering PROVENGE. Therefore, Medicare beneficiaries are able to access PROVENGE, and private payers are also able to cover PROVENGE throughout the NCA process. Currently, MACs covering 14 of the 15 regional territories have established coverage guidelines and/or provided customers with written or verbal guidance on coverage.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 1-877-336-3736
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
|SOURCE Dendreon Corporation|
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