Monday, May 14, 2001
South San Francisco and San Diego, Calif. -- May 14, 2001 --Genentech, Inc. (NYSE: DNA) and IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biological License Application (sBLA) for Rituxan (Rituximab).
The new product labeling includes retreatment with Rituxan after a prior course of Rituxan therapy, initial treatment with eight weekly infusions of Rituxan, compared to four infusions, and treatment of bulky disease (tumors greater than 10 centimeters) for patients with relapsed or refractory, low-grade or follicular, CD20 positive B-cell non-Hodgkin's lymphoma (NHL). Additionally, the two companies will emphasize already existing safety information in the revised package insert for physicians concerning rare severe and potentially fatal mucocutaneous skin reactions that have occurred in patients who have received Rituxan.
"Rituxan is an important therapy for patients with low-grade NHL who will receive multiple therapies during his or her lifetime," said Gwen Fyfe, M.D., Genentech's senior director of Oncology, Medical Affairs. "The new data contained in the approved sBLA demonstrates that patients who receive longer initial therapy or multiple courses of Rituxan have the potential to achieve a prolonged duration of response to the therapy, a significant clinical benchmark for an incurable disease. Additionally, since patients will receive multiple therapies during the course of their disease, it is important that patients can receive therapies like Rituxan that do not cause cumulative toxicity or limit future treatment options."
In an investigational Phase II multi-center, single-arm study, 60 patients with relapsed or refractory, low-grade or follicular NHL were retreated when they relapsed after obtaining an objective clinical response with their initial four week course of Rituxan. These patients received 375 mg/m2 once weekly dose of Rituxan for four weeks. Of the 60 patients, 58 received a second course and two received a third course of Rituxan.
The overall response rate was 38 percent (23/60 patients) with 10 percent achieving complete responses and 28 percent partial responses. The projected median duration of response is 15 months.
Initial Treatment with Eight Weekly Infusions
In another investigational Phase II multi-center, single-arm, multiple-dose study, 37 patients with relapsed or refractory, low-grade NHL received 375 mg/m2 of Rituxan once a week for a total of eight weekly infusions. Overall response rates were 57 percent (21/37 patients) with 14 percent of patients experiencing complete responses and 43 percent partial responses. The projected median duration of response is 13.4 months.
Results also were submitted from multiple Rituxan studies of 39 low-grade NHL patients with relapsed or refractory bulky disease, which is especially difficult to treat successfully due to the increased tumor size. In 39 patients, an overall response rate of 36 percent (14/39) was observed, with three percent achieving complete responses and 33 percent achieving partial responses. The median duration of response was 6.9 months. Each patient received 375 mg/m2 of Rituxan in four weekly infusions.
A Dear Healthcare Provider letter has been sent to physicians to enhance their understanding of adverse events that may be associated with Rituxan use. The new labeling will include information on 20 post-marketing reports of rare severe mucocutaneous reactions that have been seen in patients treated with Rituxan. Eight of these resulted in a fatal outcome. Patients experiencing these reactions have highly compromised immune systems related to their disease. Currently there has been no direct link made between these types of reactions and Rituxan, however, until more is known it is important that physicians understand that Rituxan could have contributed to some of these events and manage their patients accordingly.
These reactions have been described as paraneoplastic pemphigus (PNP), lichenoid dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, or vesiculobullous dermititis. Many of these reactions were PNP which is known to be associated with various B-cell lymphomas, particularly NHL and chronic lymphocytic leukemia (CLL). Patients experiencing these types of reactions should have their Rituxan infusion discontinued and receive appropriate medical therapy which includes a skin biopsy to help guide treatment.
"Over 100,000 people have received Rituxan worldwide in just over three years since it was approved by the FDA," said Christine A. White, M.D., vice president, Medical Affairs at IDEC. "While reference to the rare, serious and fatal skin reactions were already contained in the product package insert, this action will serve to further educate physicians about Rituxan therapy and give them the tools to make an appropriate risk and benefit analysis with their patients for this incurable disease."
The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include, but are not limited to, flu-like fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention. Administration of Rituxan weekly for eight doses or retreatment was associated with higher rates of grade 3 and 4 adverse events overall compared with the original four dose schedule. In rare instances, severe and fatal infusion-related reactions have occurred, nearly all of which have been associated with the first Rituxan infusion. These events appear as manifestations of an infusion-related complex and include hypoxia, pulmonary infiltrates, adult respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock and tumor lysis syndrome. Patients who develop clinically significant infusion-related cardiopulmonary events should have Rituxan infusion discontinued and receive medical treatment.
Genentech and IDEC
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
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 systems. IDEC is headquartered in San Diego, California, and is traded on the NASDAQ National Market System under the stock symbol, IDPH.
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, 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, 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.
For full prescribing information or more information on the information above, please call (650) 225-8681 or visit http://www.gene.com.
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