OSI Pharmaceuticals Announces Tarceva to Be Reviewed by the FDA's Oncologic Drugs Advisory Committee for Use as a First-Line ...
November 16 2009 - 10:54AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that
the Oncologic Drugs Advisory Committee (ODAC) will review the use
of Tarceva® (erlotinib) as a first-line maintenance therapy for
patients with advanced non-small cell lung cancer (NSCLC) who have
not progressed following first-line treatment with platinum-based
chemotherapy at its December 16, 2009 meeting. The ODAC panel is a
committee of external experts, formed by the U.S. Food and Drug
Administration (FDA), to advise the FDA in the evaluation of
marketed and investigational drugs for use in the treatment of
cancer.
In June 2009, the FDA accepted for filing and review the
supplemental New Drug Application (sNDA) for the use of Tarceva as
a first-line maintenance treatment for patients with advanced NSCLC
who have not progressed following first-line treatment with
platinum-based chemotherapy. In addition, the overall survival data
was included in an update to the U.S. sNDA. The FDA Prescription
Drug Fee Act (PDUFA) review date for the Tarceva application is on
or about January 18, 2010.
Tarceva is the only oral, non-chemotherapy agent shown to
provide a statistically significant improvement in both
progression-free survival (PFS) and overall survival (OS) in the
NSCLC maintenance setting.
About Lung
Cancer
According to the American Cancer Society, lung cancer is the
leading cause of cancer death in the United States. In 2009,
approximately 159,000 Americans will die from the disease. Most
people are diagnosed with advanced stage disease and only 15
percent survive five years. NSCLC is the most common type of lung
cancer.
About Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway.
Tarceva is designed to inhibit the tyrosine kinase activity of the
EGFR signaling pathway inside the cell, one of the critical growth
factors in NSCLC and pancreatic cancers. Tarceva is indicated as a
monotherapy for patients with locally advanced or metastatic NSCLC
whose disease has progressed after one or more courses of
chemotherapy. Tarceva is not intended to be used at the same time
as chemotherapy for NSCLC.
In pancreatic cancer, Tarceva is indicated in combination with
gemcitabine for the first-line treatment of patients with locally
advanced pancreatic cancer, pancreatic cancer that cannot be
surgically removed or pancreatic cancer that has spread to distant
body organs.
Tarceva Safety
There have been infrequent reports of serious Interstitial Lung
Disease (ILD)-like events including deaths in patients taking
Tarceva. Serious side effects (including deaths) in patients taking
Tarceva include liver and/or kidney problems; gastrointestinal (GI)
perforations (the development of a hole in the stomach, small
intestine, or large intestine); and severe blistering skin
reactions including cases similar to Stevens-Johnson syndrome.
Patients taking Tarceva plus gemcitabine were more likely to
experience bleeding and clotting problems such as heart attack or
stroke. Eye irritation and damage to the cornea have been reported
in patients taking Tarceva. Women should avoid becoming pregnant
and avoid breastfeeding while taking Tarceva. Patients should call
their doctor right away if they have these signs or symptoms: new
or worsening skin rash; serious or ongoing diarrhea, nausea, loss
of appetite, vomiting or stomach pain; new or worsening shortness
of breath or cough; fever; eye irritation. Rash and diarrhea were
the most common side effects associated with Tarceva in the
non-small cell lung cancer clinical study. Fatigue, rash, nausea,
loss of appetite and diarrhea were the most common side effects
associated with Tarceva plus gemcitabine therapy in the pancreatic
cancer clinical study.
For full prescribing information, please call 1-877-TARCEVA or
visit http://www.tarceva.com.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted medicines designed
to extend life and improve the quality of life for patients with
cancer and diabetes/obesity. For additional information about OSI,
please visit http://www.osip.com.
This news release contains forward-looking statements. These
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI’s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI’s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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