FDA ADVISORY COMMITTEE
RECOMMENDS CLEARANCE FOR
MARKETING OF FIRST U.S. MONOCLONAL
ANTIBODY FOR CANCER TREATMENT;
RITUXAN REVIEWED FOR USE IN
NON-HODGKIN'S LYMPHOMA
Clearance for Marketing of First U.S. Monoclonal Antibody
for Cancer Treatment; Rituxan Reviewed for Use in
Non-Hodgkin's Lymphoma Business Editors and
Health/Science Writers
SAN DIEGO and SOUTH SAN FRANCISCO--(BW
HealthWire)--July 25, 1997-- IDEC Pharmaceuticals
Corporation (NASDAQ:IDPH) and Genentech, Inc.
(NYSE:GNE) today announced that Rituxan(TM)
(Rituximab), also known as IDEC-C2B8, a monoclonal
antibody, was recommended unanimously for marketing
clearance by the Biological Response Modifiers Advisory
Committee (BRMAC) to the U.S. Food and Drug
Administration(FDA). The proposed indication is for
treatment of relapsed or refractory low grade or follicular
B-cell non-Hodgkin's lymphoma.
In an open label multi-center pivotal trial, Rituxan, when used
alone, induced tumor shrinkage of 50 percent or greater in
76 of 151 evaluable patients (50 percent response rate)
following four weekly infusions. Thus far the median duration
of response has not been reached after 9.2+ months since 48
percent of responders continue to have an ongoing response.
In clinical trials, most adverse events associated with Rituxan
are infusion-related and are transient mild to moderate
symptoms (e.g. fever, chills, headache). Infusion-related
events occur with greatest frequency upon initial
administration and are usually limited in duration to the period
of the infusion. The symptoms decrease significantly with
subsequent infusions. More serious events which occurred
with less frequency included rigors, rash, hypotension,
wheezing, infections, and recurrence of cardiac events in
patients with a history of angina or arrhythmia.
"We are pleased the Advisory committee recommended to
the FDA marketing clearance of Rituxan. The proposed
indication is for the treatment of patients with relapsed or
refractory low grade or follicular B-cell non-Hodgkin's
lymphoma," said Antonio J. Grillo-Lopez, M.D., IDEC's
senior vice president of Medical and Regulatory affairs.
"Rituxan may represent a new approach to cancer treatment;
it harnesses the body's immune system to focus on and
destroy cancer cells." "The recommended clearance for
marketing of Rituxan is an important milestone," said Susan
Hellmann, M.D., M.P.H., Genentech's vice president of
Medical Affairs and Chief Medical Officer. "Patients may
soon have a new treatment available to them, which takes
less time to administer than conventional chemotherapy with
less serious side effects."
Unlike the standard four- to six-month chemotherapy
regimen or high-dose radiation, Rituxan treatment can be
administered in four infusions one week apart on an
outpatient basis during a 22-day period. There are
approximately 240,000 patients in the United States with
B-cell non-Hodgkin's lymphomas, which are malignancies of
the body's antibody-producing immune cells. Approximately
one-half are low grade or follicular lymphoma patients who
will experience multiple relapses during the average
seven-year course of their incurable disease. Currently,
standards of treatment consist of chemotherapy and/or
radiotherapy, with their accompanying toxicity.
The role of the BRMAC is to make recommendations, which
are not binding, to the FDA on the clinical sections of
Biologic License Applications (BLAs). The BLAs submitted
by both companies, including non-clinical sections, are
currently under review by the FDA. If the FDA concurs with
the Advisory Committee recommendation, Rituxan may
become the first monoclonal antibody commercially available
for the treatment of cancer in the United States. The FDA
makes the final determination as to whether there is sufficient
clinical data and compliance with all other requirements to
support product licensure. IDEC discovered Rituxan and
developed the product in collaboration with Genentech and
F. Hoffmann-La Roche Ltd of Switzerland, and Zenyaku
Kogyo Co., Ltd. of Japan. IDEC and Genentech submitted
Biologic License Applications (BLAs) jointly to the FDA to
support their shared responsibility for product manufacture,
and the companies will be co-promoting Rituxan in the
United States. Roche will be responsible for marketing
Rituxan in the rest of the world, excluding Japan.
Genentech, Inc., is a leading biotechnology company that
discovers, develops, manufactures and markets human
pharmaceuticals for significant unmet medical needs. The
company has headquarters in South San Francisco and is
traded on the New York Stock Exchange and Pacific
Exchange under the symbol GNE. F. Hoffmann-La Roche
Ltd, with headquarters in Basel, Switzerland, is a member of
the Roche Group, a world leader in research-based health
care with major businesses in pharmaceuticals, diagnostics,
vitamins and fine chemicals, and fragrances and flavors.
Roche has a long tradition of innovative breakthroughs in
drug development and is a pioneer in the medical applications
of genetic engineering.
IDEC Pharmaceuticals focuses on developing targeted
immunotherapies for the treatment of cancer and autoimmune
disease which are primarily designed to act through immune
mechanisms. If Rituxan is licensed for marketing by the FDA,
it will be IDEC's first marketed product. IDEC
Pharmaceuticals is a registered U.S. trademark and Rituxan
is a U.S. trademark of the company, which is headquartered
in San Diego, California. The statements made in this news
release contain certain forward looking statements that
involve a number of risks and uncertainties. Actual events or
results may differ from IDEC's expectations. In addition to
the matters described in this news release, ultimate licensing
or the timing thereof by the FDA and approval by other
regulatory agencies, as well as the risk factors listed from
time to time in IDEC's SEC filings, including but not limited to
its annual reports on Form 10-K for the year ended
December 31, 1996 and Form 10-Q filed May 13, 1997,
may affect the actual results achieved by IDEC. |
