(BW HealthWire) — IDEC Pharmaceuticals Corporation (NASDAQ: IDPH) announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended approval of ZEVALIN(TM) (Ibritumomab Tiuxetan), an investigational agent, for the proposed treatment of rituximab-refractory follicular, B-cell non-Hodgkin’s lymphoma (NHL).
With respect to the use of ZEVALIN for treatment of patients that are not rituximab-refractory, that is, patients with relapsed or refractory, low grade, follicular or CD20-positive transformed, B-cell NHL, the Committee recommended that the FDA consider approval of ZEVALIN in this indication under the agency’s accelerated approval regulations. While the ZEVALIN BLA was not filed under the accelerated approval regulations, given the Committee’s recommendations, the Company will discuss with the FDA the merits of an accelerated approval approach for ZEVALIN and its implications on product labeling and the timing of BLA approval.
The Advisory Committee consists of individuals recognized as experts in various fields including medicine, science and research, industry, and consumer/patient advocacy. While the Committee’s recommendations are a milestone, the FDA will determine the applicability of the accelerated approval regulations and will make the final decision whether or not to approve ZEVALIN. IDEC will continue to work with the FDA to implement the Advisory Committee’s recommendations.
“We are delighted the Advisory Committee recommended approval of a first-in-class radioimmunotherapy,” said William H. Rastetter, Ph.D., Chairman, Chief Executive Officer and President of IDEC. “ZEVALIN represents years of tireless work on the part of hundreds of IDEC employees. If approved by the FDA, we believe ZEVALIN will provide a potential treatment alternative for certain non-Hodgkin’s lymphoma patients.”
Christine A. White, M.D., IDEC’s Vice President of Medical Affairs, gave the Company’s scientific and medical presentation of ZEVALIN data to the ODAC panel. More than 500 NHL patients have been treated with ZEVALIN in clinical trials sponsored by IDEC throughout the U.S.
IDEC Pharmaceuticals focuses on the commercialization and development of targeted therapies for the treatment of cancer and autoimmune diseases. IDEC’s antibody products act chiefly through immune system mechanisms, exerting their effect by binding to specific, readily targeted immune cells in the patient’s blood or lymphatic system. For a menu of IDEC’s current news releases and quarterly reports or to retrieve a specific release, call (888) 329-2309. On the Internet check the News Center at IDEC’s website: http://idecpharm.cdmail.biz.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from IDEC’s expectations. For example, the timing, success and cost of preclinical research and clinical studies, the timing, acceptability and review periods for regulatory filings, the timing of and ability to obtain regulatory approval of products, such as ZEVALIN, the achievement of future product sales, the level of manufacturing performance and the risk factors listed from time to time in IDEC’s SEC filings including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2000 and Form 10-Q for the quarter ended June 30, 2001, may affect the actual results achieved by IDEC. These forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
IDEC Pharmaceuticals is a registered U.S. trademark of the Company. ZEVALIN is a trademark of the Company. Rituxamab is the generic name for the Company’s approved drug Rituxan(R), a registered U.S. trademark. The Company’s headquarters are located at 3030 Callan Road, San Diego, CA 92121.
IDEC Pharmaceuticals’ press releases are available at no charge through Business Wire’s News on Demand Plus. For a menu of IDEC’s current press releases and quarterly reports or to retrieve a specific release, call 888/329-2309. On the Internet, check the News Center at IDEC’s website: http://idecpharm.cdmail.biz.
CONTACT: IDEC Pharmaceuticals Corporation Vince Reardon, Director, Corporate Communications 858/431-8656
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