Besides the main press release on Rituxan, I wanted to get my arms
around many the other press releases. (Most of you know how I like to
consolidate). Anyway, here are 7 (mostly redundant) articles on the
Rituxan FDA approval from last week.
FDA OKs New Lymphona Cancer Drug
The Associated Press
By LAURAN NEERGAARD
WASHINGTON (AP) - Thousands of patients with an incurable type of
non-Hodgkin's lymphoma won their first new weapon in a decade
The Food and Drug Administration approved a novel, genetically
engineered drug to attack the immune system cancer with far fewer side
effects than standard treatment.
Rituxan is not a cure, but the FDA said it has an ``excellent'' success rate
in shrinking tumors safely.
The approval makes Rituxan the nation's first anti-cancer monoclonal
antibody - a long-awaited biotherapy in which specially manufactured
antibodies bind to cancer cells and trigger the immune system to do the
killing instead of toxic chemicals.
One patient who tested Rituxan called the approval ``something to
celebrate this Thanksgiving.''
``Even though my type of lymphoma is still considered incurable, Rituxan
has renewed my hope of raising my three children,'' said Dr. Wendy
Harpham, a Richardson, Texas, physician who failed other treatments
before Rituxan therapy put her cancer in remission.
About 240,000 Americans have non-Hodgkin's lymphoma, a cancer of the
lymph system that targets vital white blood cells. Many patients are
successfully treated. But about half of them have an incurable form called
low-grade non-Hodgkin's that causes repeat relapses over six or seven
These patients try high doses of chemotherapy, radiation and bone
marrow transplants that can cause severe side effects, particularly
when these treatments also kill healthy cells that get in the way.
Rituxan, on the other hand, is made from a genetically engineered mouse
antibody designed to be a more specific treatment. Scientists don't know
exactly how it works, said FDA monoclonal antibody chief Kathryn Stein.
But ultimately these antibodies zero in on the white blood cells involved in
non-Hodgkin's lymphoma and trigger their death.
``This is the first of what we hope will be many monoclonal antibodies for
tumor treatment,'' she said.
In a study of 166 patients with advanced cancer, 48 percent had their
tumors shrink by at least half. Six percent of patients had complete
remissions. Half the successful patients remained stable for more than 11
months, a rate that Stein called ``excellent.''
Rituxan therapy does not require hospitalization. Manufacturers IDEC
Pharmaceuticals and Genentech Inc. say Rituxan, known chemically as
rituximab, will be available within a month. A complete course of four
weekly transfusions will cost roughly $9,000, comparable to many
Rituxan has some risks. It can kill healthy white blood cells as well as
cancerous ones, meaning patients could suffer infections although no
unusual rates have appeared so far, said Dr. Peter McLaughlin of the
M.D. Anderson Cancer Center, the drug's lead investigator. Those cells
grow back on their own within a year.
Additionally, most patients have temporary and mild flu-like symptoms,
such as fever and chills, one to two hours after the first infusion, as their
bodies learn to recognize the new antibody, he said.
So few side effects make Rituxan a prime candidate to give to lymphoma
patients in addition to chemotherapy, hoping for a one-two punch against
the disease, McLaughlin said. Doctors already are studying how well
such a combination could work, as well as the feasibility of giving it to
earlier patients instead of waiting until they relapse.
But for patients today, Rituxan promises to buy some time. Harpham says
if she hadn't gotten to test the drug, she would already have tried her last
option - a bone marrow transplant that she still can turn to if she has
Still, ``Rituxan has been the closest answer to my prayers so far,'' she
SOURCE: Lymphoma Patient Organization
Lymphoma Patient Organization Welcomes FDA Approval of Rituxan; First
Monoclonal Antibody Licensed To Treat Cancer in US
05:01 p.m Nov 26, 1997 Eastern LOS ANGELES, Nov. 26 /PRNewswire.
The Lymphoma Research Foundation of America, which represents more
than 12,000 lymphoma patients and their families, welcomes the Food and
Drug Administration announcement that Rituxan has been cleared for
marketing. The drug is the first new single-agent therapy for
non-Hodgkin's lymphoma in 10 years and the first monoclonal antibody
licensed for the treatment of cancer in the United States.
Ellen Glesby Cohen, President and Founder of the Lymphoma Research
Foundation of America said, "The approval is an exciting step forward
toward the goal of better and safer treatments for lymphoma and
hopefully other cancers. The challenge now is how to expand the use of
this product, perhaps in combination with standard therapies, to prolong
the duration of remission for the countless number of people who have
Each year approximately 85,000 people are diagnosed with some form of
lymphoma. Approximately 35,000 of the cases are incurable. Over the
last 20 years the incidence of lymphoma has increased by 50% while the
incidence of other cancers has been falling.
Source: SEATTLE--(BW HealthWire)
McCamant Calls FDA Approval of Lymphoma Drug 'Good News' for IDEC,
05:31 p.m Nov 26, 1997 Eastern SEATTLE--(BW
HealthWire)--Nov. 26, 1997--Today's Food and Drug Administration (FDA)
approval for marketing Rituxan, a single-agent monoclonal antibody
therapy for treatment of non-Hodgkin's lymphoma, is "good news" for
patients and Rituxan's marketing partners, according to a leading
James McCamant, editor of the Medical Stock Technology Newsletter,
said while the approval was "totally expected, it's good that it has
happened." He predicted Rituxan will become a "significant product" for
IDEC Pharmaceuticals (NASDAQ:IDPH), discoverer of the product, and
Genentech (NYSE:GNE), which helped IDEC develop Rituxan along with
F. Hoffman-LaRoche of Switzerland and Zenyaku Kogyo of Japan.
"Genentech historically has been an excellent marketing company and
should do a good job with Rituxan," McCamant said. "We don't know
pricing yet, but this could be a better-than $200 million market. It
also shows Genentech's commitment to the cancer area." Medical
experts call Rituxan important in treating low-level lymphoma because its
side effects are less serious than conventional chemotherapy and
radiation therapy. Also, Rituxan treatment can be completed in 22 days
vs. four-to-six months in chemotherapy and radiotherapy. About 250,000
patients in the U.S. suffer from B-cell non-Hodgkin's lymphomas. About
half arelow-grade or follicular patients. A portion of those will be eligible
for Rituxan therapy. IDEC CEO William Rastetter called the approval of
Rituxan "an important milestone in the treatment of cancer." Genentech's
CEO Arthur Levinson said Rituxan is the first of a series of drugs that will
come from Genentech's BioOncology initiative. McCamant will be a
keynote speaker along with Michael Murphy at the 1997 Informed
Investors Seattle Biotech Forum on Saturday Dec. 13. Murphy, editor of
the California Technology Stock Letter, is also a leading biotechnology
For information about attending the Biotech Forum or ordering audio
tapes of the Forum, see Informed Investors' website at
http://www.informedinvestors.com/seabio3.html or call 800/992-4683.
Genentech is a presenting company at the Forum, which offers individual
investors analyst-style presentations that typically are closed to the
Other presenting companies include: Ligand Pharmaceuticals
(NASDAQ:LGND) and Seattle area-based companies ALCIDE Corp.
(NASDAQ:ALCD), ICOS Corp. (NASDAQ:ICOS), Cell Therapeutics
(NASDAQ:CTIC), Sonus Pharmaceuticals (NASDAQ:SNUS), Corixa Corp.
(NASDAQ:CRXA) and QLT Phototherapeutics (NASDAQ:QLTIF) of
Vancouver, B.C. "It appears the FDA again will repeat its pattern of
announcing a lot of approvals near year end," McCamant said in an
interview with Informed Investors. "In recent years, about 50% of
approvals have been announced in November and December and
it looks like that might be the case again."
Murphy kicks off the conference with his keynote address. McCamant is
the luncheon keynote speaker. Both will participate in a panel
discussion, "What Biotechs To Buy Now," following lunch.
Since 1993, Sacramento-based Informed Investors has been linking
investors with management of public companies. Informed Investors
represents individual investors who collectively hold an estimated $1.3
billion in investable assets. (See also: http://www.businesswire.com)
Source: SAN DIEGO and SOUTH SAN FRANCISCO, Calif.--(BW
First New Drug for Non-Hodgkin's Lymphoma in Decade Receives FDA
Clearance for Marketing; First U.S. Monoclonal Antibody for Therapeutic
Use in Cancer
08:53 a.m. Nov 26, 1997 Eastern SAN DIEGO and SOUTH SAN
FRANCISCO, Calif.--(BW HealthWire)-- Nov. 26, 1997--IDEC
Pharmaceuticals Corporation (NASDAQ:IDPH) and Genentech, Inc.
(NYSE:GNE) today announced that RITUXAN(TM) (Rituximab) has been
cleared for marketing by the U.S. Food and Drug Administration (FDA).
Rituxan, previously know as the C2B8 antibody, is a single-agent
monoclonal antibody therapy for the treatment of relapsed or refractory
low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma.
In the pivotal trial conducted at 31 U.S. sites, Rituxan, when used
alone, showed a 48 percent overall response rate. Eighty of 166 patients
experienced tumor shrinkage of 50 percent or greater following four
weekly infusions. The median duration of response is projected to be
10-12 months. Patients continue to be monitored. These results
corroborated those seen in earlier studies.
In clinical trials, the most common adverse events associated with
Rituxan were infusion-related, consisting mainly of mild to moderate
flu-like symptoms (e.g., fever, chills, rigors) that occurred in the majority
of patients during the first infusion. Other events which occurred with
less frequency included nausea, rashes, fatigue and headache. More
serious events included hypotension, wheezing, sensation of tongue or
throat swelling and recurrence of cardiac events in patients with a
history of angina or arrhythmia. These symptoms were usually limited in
duration to the period of infusion and decreased with subsequent
Rituxan is the first new single-agent therapy in 10 years for
non-Hodgkin's lymphoma and the first monoclonal antibody licensed for
the treatment of cancer in the United States. Rituxan also represents
the first marketed monoclonal antibody product for Genentech's
BioOncology initiative, and is the first marketed product for IDEC. It
is expected to be commercially available for use within approximately
FDA approves monoclonal antibody for cancer treatment
By Andrea Orr
LOS ANGELES, Nov 26 (Reuters) - The U.S. Food and Drug
Administration on Wednesday approved a new cancer drug that
stimulates the body's immune system to fight the disease, and could limit
the need for foreign agents like chemotherapy.
Although the drug, Rituxan, was approved only for the treatment of one
type of cancer, it is a critical first step in longstanding efforts to come up
with less toxic cancer drugs.
Rituxan, approved for the treatment of non-Hodgkin's lymphoma, is based
on a ``monclonal antibody,'' a version of the body's disease-fighting
agents that has been genetically engineered to attack cancer cells.
``There are side effects, but they should be milder than the side effects
of chemotherapy,'' said Bill Young, chief executive officer of South San
Francisco-based Genentech Inc (NYSE:GNE - news), which developed
the drug in collaboration with IDEC Pharmaceuticals Corp (Nasdaq:IDPH -
news) in San Diego.
The companies said the drug should be available in about three weeks.
About 250,000 people in the United States suffer from non-Hodgkin's
lymphoma, a cancer of the immune system.
The incidence of lymphoma has increased three-fold over the past 20
years. The increase is believed to be due partly toenvironmental toxins,
although a clear link has not been identified. Non-Hodgkin's lymphoma is a
form of the disease that is especially difficult to treat.
Doctors have for decades been trying to harness the human immune
system to attack cancerous cells. In recent years, they discovered that
non-Hodgkin's lymphoma was especially receptive to this kind of
Rituxan works by binding to a protein on the body's B cells, a type of
immune cell that non-Hodgkin's lymphoma strikes. The drug then recruits
the body's natural defenses to attack and kill the B cells.
While Rituxan is the first drug of its kind to win U.S. approval, it is
as precise as doctors would like. Most consider Rituxan a more
significant development for the research community than it is for people
who have cancer.
It is widely expected that Rituxan will be prescribed in conjunction with
chemotherapy, at least initially, to give patients the best possible chances
In a clinical trial, Rituxan shrunk tumors by 50 percent or more in 48
percent of patients treated -- encouraging results but not a cure.
Another problem is that Rituxan cannot differentiate between healthy and
cancerous B cells, and therefore winds up killing both kinds. Still, the
healthy B cells do grow back after treatment. And unlike chemotherapy,
Rituxan spares other kinds of cells surrounding the cancer.
Cancer researchers hope they will eventually find monoclonal antibodies
that work against other types of cancer.
Genentech has developed another drug based on a monoclonal antibody
that attacks breast cancer. It recently completed Phase III trials and is
preparing to announce results.
``I hope the lessons we've learned from lymphoma research will help us
find similar targets in non-hematologic cancers, but we have a lot more
studying to do first,'' said Dr. Mark Kaminski, director of leukemia and
lymphoma research at the University of Michigan cancer center.
Kaminski works as a consultant to another company, Coulter
Pharmaceutical Inc (Nasdaq:CLTR - news), which has a drug similar to
Rituxan in development. Coulter combined a monoclonal antibody with a
radioactive isotope, which takes radiation therapy to the diseased cells,
forming a double punch against the cancer.
Coulter recently reported its drug had shrunk the tumors in 60 percent of
patients with non-Hodgkin's lymphoma, and appeared to eradicate tumors
in 27 percent of the patients.
``I'm hoping for the day when we won't have to use chemotherapy, and
will have a cancer treatment that is more intelligent than the hit-or-miss
approach we use now, '' said Kaminski.
"Rituxan represents an important turning point in the treatment of
lymphoma," said Myron Czuczman, M.D., Assistant Professor of Medicine,
Roswell Park Cancer Institute, Buffalo, New York, and a key
investigator. "Although it is not a cure, we finally have a cancer agent
that can be effective with less serious side effects than with
conventional chemotherapy. Treatment can also be completed in 22 days,
unlike the typical four- to six-month chemotherapy regimens. This is
exciting news, especially for elderly patients and relapsed patients who
have failed at least one standard treatment regimen."
"We are very pleased that Rituxan has been cleared for marketing as it
marks an important milestone in the treatment of cancer," said William
H. Rastetter, Ph.D., IDEC Pharmaceuticals' chairman, president and chief
executive officer. "IDEC and Genentech are committed to continue
exploration of further uses of Rituxan as a first line therapy for
low-grade lymphoma, in combination with other anti-cancer treatments for
lymphoma, and in intermediate- and high-grade
"The licensing of Rituxan affirms our strategy of pairing Genentech's
existing strengths with our partners' development resources in order to
bring important new products to market," said Arthur D. Levinson, Ph.D.,
Genentech's president and chief executive officer. "Rituxan is the first
to be promoted in a series of innovative biotherapeutic cancer agents
that will follow from Genentech's pipeline. It will be co-promoted by
Genentech and IDEC and supported by both companies' newly
established oncology sales forces."
There are approximately 250,000 patients in the United States with
B-cell non-Hodgkin's lymphomas, which are malignancies of the body's
antibody-producing immune system cells. Approximately one-half are
low-grade or follicular lymphoma patients. A portion of these patients
will have multiple relapses and may be eligible for Rituxan therapy.
Currently, standard treatment consists of chemotherapy and/or
Unlike the typical four- to six-month chemotherapy regimen or high-dose
radiation treatment, Rituxan can be administered in four infusions on an
outpatient basis over a 22-day period.
Rituxan works by binding to a particular protein (the CD20 antigen) on
the surface of mature B cells and B-cell tumors. Then it recruits the
body's natural defenses to attack and kill both malignant and normal
mature B cells. Stem cells present in the bone marrow lack the CD20
ntigen and are, therefore, not affected by the treatment. In clinical
studies, B cells returned to normal levels within several months after
completion of treatment.
IDEC discovered Rituxan and developed the product in collaboration
with Genentech, F. Hoffman-La Roche, Ltd of Switzerland and Zenyaku
Kogyo Co., Ltd. of Japan. IDEC and Genentech will be co-promoting
Rituxan in the United States and will have shared responsibility for
product manufacture. Roche will be responsible for marketing Rituxan in
the rest of the world, excluding Japan. In financial reporting,
Genentech will book all the sales and Genentech expenses related to the
product in the United States. The profit will be split between the two
companies based on a formula which provides Genentech with the
Genentech, Inc. is a leading biotechnology company that discovers,
develops, manufactures and markets human pharmaceuticals for
significant unmet medical needs. Eleven of the currently marketed
biotechnology products stem from Genentech science. Genentech
markets or promotes eight biotechnology products in the United States.
The company has headquarters in South San Francisco and is traded on
the New York Stock Exchange and Pacific Exchange under the symbol
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. IDEC Pharmaceuticals is a
registered U.S. trademark, and Rituxan is a U.S. trademark of IDEC,
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, timelines for ongoing and
future clinical activity are subject to change, results of pending or future
clinical trials cannot be accurately predicted and decisions by the FDA
and other regulatory agencies, including their determination is to whether
there is sufficient clinical data and compliance with all other requirements
to support product licensure, 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/A filed August 18, 1997, may affect the actual results achieved
For full prescribing information or a copy of an interactive press kit,
please call (650) 225-8751. (See also: http://www.businesswire.com)
U.S. Department of Health and Human Services
P97-39 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Print Media (LG): 301-827-6242
Nov 26, 1997 Broadcast Media: 301-827-3434
Consumer Inquires: 800-532-4440
FIRST MONOCLONAL ANTIBODY APPROVED TO TREAT CANCER
FDA today approved the first biotechnology product to treat
patients with one type of non-Hodgkin's lymphoma (NHL), a cancer of the
The product, rituximab, is a monoclonal antibody that is effective
for patients with low-grade B-cell NHL who have not responded to
standard treatments. Rituximab targets and destroys white blood cells
(B-cells) involved in the disease, resulting in significant tumor
shrinkage with less severe side-effects than most cancer treatments. In
the United States, approximately 240,000 people have B-cell NHL, and
about 50 percent of this group are of the low-grade or follicular
subgroup of NHL, which is ultimately incurable. Patients with this type
of NHL may remain in remission for years but eventually have multiple
recurrences of their symptoms or relapses that occur more frequently
over the course of the disease. Rituximab is a genetically engineered
version of a mouse antibody that contains both human and mouse
components. It can be produced in large quantities in the laboratory.
Because specific cells are targeted with rituximab, rather than all
fast-growing cells, as is the case for most chemotherapy, NHL patients
suffer fewer serious side effects than with other treatments.
"Decades of basic scientific research have culminated in the first
monoclonal antibody product to treat cancer," said Lead Deputy FDA
Commissioner Michael A. Friedman, M.D. "Although not yet the magic
bullet we are looking for, it will give patients and their physicians
another less toxic treatment option when other treatments fail."
In the main clinical study of 166 patients with advanced low-grade
or slow-growing NHL, tumors shrunk by at least one-half in 48 percent of
the patients who completed the treatment with 6 percent having complete
remissions. All of these patients had received at least one other form
of chemotherapy before the clinical trial. The positive results have
been long-lasting, with half of the patients who responded staying in
remission for more than 11 months. Studies on these patients are
The most common side effects associated with rituximab were related
to the intravenous infusion itself and involved mild to moderate
flu-like symptoms. These symptoms occurred predominantly with the first
treatment, were limited to the period of infusion and were less common
and less severe with subsequent infusions. Hospitalization is not
required to administer the product.
Because rituximab destroys healthy immune cells as well as
cancerous ones, concerns existed about patients' being prone to
infections. However, patients in the clinical trial had no more
infections than would be expected given their disease and damage to
their immune systems from prior treatments
IDEC Pharmaceuticals Corporation, San Diego, Calif., and Genentech,
Inc., San Francisco, Calif., co-developed the product and will market it
in the United States under the trade-name Rituxan. FDA completed its
review of the license application in five months, and the product was
approved four months later, following the resolution of outstanding