NEW YORK, Oct. 2 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated
(Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced
that the U.S. Food and Drug Administration (FDA) has approved an update to
the ERBITUX(R) (Cetuximab) product labeling to include overall survival
data as a single agent in epidermal growth factor inhibitor
(EGFR)-expressing metastatic colorectal cancer (mCRC) patients after
failure of both irinotecan- and oxaliplatin-based regimens.
The approval of the supplemental biologics license application (sBLA)
is based on prolonged overall survival from a large, randomized,
multicenter, Phase III trial comparing ERBITUX plus best supportive care
(BSC) to BSC alone in 572 EGFR-expressing mCRC patients after failure of
irinotecan- and oxaliplatin-based regimens. BSC was considered to be all
approved palliative therapies designed to alleviate pain and treat other
effects caused by mCRC in this patient population.
"We are very pleased that the FDA has recognized these data as the
second disease setting where ERBITUX has improved overall survival - which
is the ultimate goal of all cancer therapies," said Eric K Rowinsky, M.D.,
Chief Medical Officer and Senior Vice President of ImClone Systems. "This
approval for ERBITUX as a monotherapy offers an additional treatment option
for an expanded patient population, specifically, patients who have failed
both irinotecan- and oxaliplatin-based chemotherapy regimens."
"ERBITUX is now the only approved biologic therapy to demonstrate
improved overall survival as a single agent in patients with metastatic
colorectal cancer," said Martin Birkhofer, M.D., Vice President, Oncology
Global Medical Affairs, Bristol-Myers Squibb. "We continue to be encouraged
by the benefits of ERBITUX in metastatic colorectal cancer, and are
actively exploring its potential in other tumor types."
About Colorectal Cancer
In the U.S., approximately 154,000 people will be diagnosed with cancer
of the colon or rectum this year. More than half of these patients have
metastatic disease, or cancer that has spread to other organs, at the time
of diagnosis. EGFR is expressed in 60-80 percent of colorectal cancer
tumors. Colorectal cancer is the third most common cancer in both men and
women, excluding skin cancer.
About ERBITUX(R) (Cetuximab)
ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the
function of a molecular structure expressed on the surface of normal and
tumor cells called the epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1). In vitro assays and in vivo animal studies have shown that
binding of ERBITUX to the EGFR blocks phosphorylation and activation of
receptor-associated kinases, resulting in inhibition of cell growth,
induction of apoptosis, and decreased matrix metalloproteinase and vascular
endothelial growth factor production. In vitro, ERBITUX can mediate
antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor
types. While the mechanism of ERBITUX's anti- tumor effect(s) in vivo is
unknown, all of these processes may contribute to the overall therapeutic
effect of ERBITUX. EGFR is part of a signaling pathway that is linked to
the growth and development of many human cancers, including those of the
head and neck, colon and rectum.
ERBITUX, as a single agent, is indicated for the treatment of EGFR-
expressing, metastatic colorectal carcinoma (mCRC) after failure of both
irinotecan-and oxaliplatin-based regimes. ERBITUX, as a single agent, is
also indicated for the treatment of EGFR-expressing mCRC in patients who
are intolerant to irinotecan-based regimens.
For full prescribing information, including boxed WARNINGS regarding
infusion reactions and cardiopulmonary arrest, visit
http://www.ERBITUX.com.
IMPORTANT SAFETY INFORMATION
Grade 3/4 infusion reactions occurred in approximately 3% of patients
receiving ERBITUX (Cetuximab) in clinical trials with fatal outcome
reported in less than 1 in 1000. Reactions characterized by rapid onset of
airway obstruction (bronchospasm, stridor, hoarseness), urticaria,
hypotension, loss of consciousness, and/or cardiac arrest. Severe infusion
reactions require immediate and permanent discontinuation of ERBITUX
therapy
Most reactions (90%) were associated with the first infusion of ERBITUX
despite premedication with antihistamines. Caution must be exercised with
every ERBITUX infusion as there were patients who experienced their first
severe infusion reaction during later infusions. Monitor patients for
1-hour following ERBITUX infusions in a setting with resuscitation
equipment and other agents necessary to treat anaphylaxis (e.g.,
epinephrine, corticosteroids, intravenous antihistamines, bronchodilators,
and oxygen). Longer observation periods may be required in patients who
require treatment for infusion reactions
Severe cases of interstitial lung disease (ILD), which was fatal in one
case, occurred in 4 of 1570 (<0.5%) of patients receiving ERBITUX in
clinical trials. Permanently discontinue ERBITUX where ILD is confirmed.
In clinical studies of ERBITUX, dermatologic toxicities, including
acneform rash, skin drying and fissuring, paronychial inflammation,
infectious sequelae (eg, S. aureus sepsis, abscess formation, cellulitis,
blepharitis, cheilitis), and hypertrichosis occurred in patients receiving
ERBITUX therapy. Acneform rash occurred in 76-88% of 1373 patients
receiving ERBIUTX in clinical trials. Severe acneform rash occurred in
1-17% of patients. Acneform rash usually developed within the first two
weeks of therapy and resolved in a majority of the patients after cessation
of treatment, although in nearly half, the event continued beyond 28 days.
Monitor patients receiving ERBITUX for dermatologic toxicities and
infectious sequelae. Sun exposure may exacerbate these effects
In women of childbearing potential, appropriate contraceptive measures
must be used during treatment with ERBITUX and for 6 months following the
last dose of ERBITUX. If ERBITUX is used during pregnancy or if patients
become pregnant while receiving ERBITUX, patients should be apprised of the
potential risk for loss of pregnancy or potential hazard to the fetus
Hypomagnesemia occurred in 55% (199/365) of patients receiving ERBITUX
and was severe (NCI CTC grades 3 & 4) in 6-17%. The onset of hypomagnesemia
and accompanying electrolyte abnormalities occurred days to months after
initiation of ERBITUX. Monitor patients periodically for hypomagnesemia,
hypocalcemia and hypokalemia, during and for at least 8 weeks following the
completion of ERBITUX. Replete electrolytes as necessary
The most serious adverse reactions associated with ERBITUX in mCRC
patients are infusion reactions, dermatologic toxicity, sepsis, renal
failure, interstitial lung disease, and pulmonary embolus.
The most common adverse reactions with ERBITUX (incidence greater than
or equal to 25% in the ERBITUX plus best supportive care arm (BSC)) (n=288)
vs. BSC (n=274), respectively, were fatigue (89%, 76%), rash/desquamation
(89%, 16%), abdominal pain (59%, 52%), pain-other (51%, 34%), dry skin
(49%, 11%), dyspnea (48%, 43%), constipation (46%, 38%), pruritus (40%,
8%), diarrhea (39%, 20%), vomiting (37%, 29%), infection without
neutropenia (35%, 17%), headache (33%, 11%), fever (30%, 18%), insomnia
(30%, 15%), cough (29%, 19%), dermatology-other (27%, 6%), and stomatitis
(25%, 10%).
About ImClone Systems
ImClone Systems Incorporated is a fully integrated biopharmaceutical
company committed to advancing oncology care by developing and
commercializing a portfolio of targeted biologic treatments designed to
address the medical needs of patients with a variety of cancers. The
Company's research and development programs include growth factor blockers
and angiogenesis inhibitors. ImClone Systems' headquarters and research
operations are located in New York City, with additional administration and
manufacturing facilities in Branchburg, New Jersey. For more information
about ImClone Systems, please visit the Company's web site at
http://www.imclone.com.
ERBITUX(R) is a registered trademark of ImClone Systems Incorporated.
Certain matters discussed in this news release may constitute forward-
looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and the Federal securities laws. Although the company
believes that the expectations reflected in such forward-looking statements
are based upon reasonable assumptions it can give no assurance that its
expectations will be achieved. Forward-looking information is subject to
certain risks, trends and uncertainties that could cause actual results to
differ materially from those projected. Many of these factors are beyond
the company's ability to control or predict. Important factors that may
cause actual results to differ materially and could impact the company and
the statements contained in this news release can be found in the company's
filings with the Securities and Exchange Commission, including quarterly
reports on Form 10-Q, current reports on Form 8-K and annual reports on
Form 10-K. For forward-looking statements in this news release, the company
claims the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995. The
company assumes no obligation to update or supplement any forward-looking
statements whether as a result of new information, future events or
otherwise.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development and
exhaustive exploration of innovative cancer fighting therapies designed to
extend and enhance the lives of patients living with cancer. More than 40
years ago, Bristol-Myers Squibb built a unified vision for the future of
cancer treatment. With expertise, dedication and resolve, that vision led
to the development of a diverse global portfolio of anti-cancer therapies
that are an important cornerstone of care today. Hundreds of scientists at
Bristol- Myers Squibb's Pharmaceutical Research Institute are studying ways
to improve current cancer treatments and identify better, more effective
medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. There can be
no guarantee that the clinical development of the use of ERBITUX for the
treatment of other tumor types will be successful. Forward-looking
statements in this press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb's business, particularly
those identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31, 2006,
in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K..
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
SOURCE Bristol-Myers Squibb Company; ImClone Systems Incorporated
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Related links:
http://www.imclone.com
http://www.ERBITUX.com
CONTACT:
Rebecca Gregory, Corporate Communications,
+1-646-638-5058, Rebecca.Gregory@imclone.com, or Tracy Henrikson,
Corporate Communications, +1-908-243-9945,
Tracy.Henrikson@imclone.com, both of ImClone Systems
Incorporated; Media, Madeline Malia, +1-609-252-3347,
Madeline.Malia@bms.com, or Tony Plohoros, +1-609-252-7938,
Tony.Plohoros@bms.com, or Investors, John Elicker,
+1-212-546-3775, John.Elicker@bms.com, all of Bristol-Myers
Squibb
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