By Kim Coghill
BETHESDA, Md. ¿ IDEC Pharmaceuticals Corp. Tuesday won recommended approval of Zevalin, a radioimmunotherapy for non-Hodgkin¿s lymphoma (NHL).
The Oncologic Drugs Advisory Committee voted 13 to 2 in favor of accelerated approval of Zevalin (ibritumomab tiuxetan) for patients who have not failed Rituxan (rituximab), a treatment for chemotherapy-refractory, low-grade, non-follicular NHL that is co-promoted in the U.S. by Genentech Inc., of South San Francisco, and IDEC, of San Diego.
And the panel voted unanimously in favor of Zevalin for Rituxan-refractory patients.
IDEC had sought approval for both indications, but had not sought accelerated approval.
But ODAC¿s chairwoman, Stacy Nerenstone, added the accelerated approval question in an attempt to force IDEC into Phase IV trials as a method of collecting additional information. Nerenstone is an associate clinical professor and a physician at Helen & Harry Gary Cancer Center at Hartford Hospital in Hartford, Conn.
Zevalin is used to shrink tumors but may have some adverse effects, including a reduction in blood cell counts.
The FDA makes the final decision on drug approvals, and typically follows the advice of its panels.
George Sledge, a panel member and professor in the department of medicine and pathology at Indiana University School of Medicine in Indianapolis, said he wouldn¿t vote for accelerated approval, ¿because I think it is a back door to approval when more information is needed.¿
Others, including Scott Lippman, a panel member and professor of medicine and cancer prevention at the University of Texas Department of Clinical Cancer Prevention in Houston, said he agreed with an accelerated approval because it mandates a Phase IV trial.
Following the meeting, William Rastetter, IDEC¿s chairman, president and CEO, said the votes were a positive move for the company. ¿This is a great outcome for us and we¿ll work with the FDA to progress forward.¿
Rastetter wouldn¿t speculate on a launch date or anticipated revenues from Zevalin. However, Lehman Brothers, of New York, released a statement saying Zevalin should be launched in early 2002 and should generate about $70 million in sales during the first year.
Zevalin is the first radioimmunotherapy to make it to an FDA panel, and with approval, it would be the first product IDEC has developed and taken to market on its own. Rituxan was discovered by IDEC and was jointly developed by IDEC, F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Zenyaku, Kogyo Co. Ltd., of Japan.
Radioimmunotherapies are a new type of cancer treatment made by linking monoclonal antibodies (antibodies created in a laboratory to recognize and attach to substances on the surface of certain cells) to radioactive isotopes. When infused into a patient, the antibodies locate and bind to the surface of specific tumor cells and then deliver their cytotoxic radiation directly to malignant cells.
IDEC presented data from a Phase III randomized, controlled study of 143 patients with relapsed or refractory low-grade, follicular, or CD20-positive transformed B-cell NHL. The company reported that the Zevalin combined with Rituxan showed a response rate of 80 percent compared to 56 percent in the control (Rituxan alone) arm. A second pivotal Phase III trial in 54 follicular NHL patients showed an overall response rate of 54 percent.
IDEC submitted its biologics license application in early November and in May the FDA requested more clinical, chemistry, manufacturing and control data. (See BioWorld Today, May 11, 2000, and Nov. 2, 2000.)
In a deal worth about $47 million, IDEC partnered with Schering AG, of Berlin, for the rights to Zevalin. IDEC retains all rights in the U.S. (See BioWorld Today, May, 11, 2001.)
Materials released from the company say there are about 55,000 new cases of non-Hodgkin¿s lymphoma each year and the median age for diagnosis is 60.
Meanwhile, IDEC released a statement Tuesday afternoon saying it has filed two separate lawsuits in federal court in California for declaratory judgment for patent non-infringement and invalidity. One suit is against Corixa Corp., of Seattle; Coulter Pharmaceuticals Inc., of San Francisco; and the University of Michigan on six patents on products and processes related to radioimmunotherapy. The other is against GlaxoSmithKline plc, of London, on two patents relating to cell culture media.
Corixa and GlaxoSmithKline Wednesday afternoon released a statement saying they have filed a lawsuit against IDEC for alleged patent infringement on Zevalin. The companies are asking the court to declare that IDEC is willfully infringing on Corixa¿s patents. The companies are seeking ¿available remedies under the patent laws,¿ according to the statement.