OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Genentech, Inc.,
(NYSE: DNA) today announced that OSI submitted a supplemental New
Drug Application (sNDA) to the U.S. Food and Drug Administration
(FDA) for the use of Tarceva� (erlotinib) as a first-line
maintenance therapy for people with advanced non-small cell lung
cancer (NSCLC) who have not progressed following first-line
treatment with platinum-based chemotherapy. Additionally, the
Companies announced that Roche, their international collaborator
for Tarceva, filed an application in Europe with the European
Medicines Agency (EMEA).
�If approved, Tarceva will be the first EGFR targeted and oral
therapy available as a first-line maintenance treatment for people
with NSCLC, which we believe is an important advancement in the
treatment of lung cancer,� stated Colin Goddard, Ph.D., Chief
Executive Officer of OSI Pharmaceuticals.
�The FDA application reflects our goal of extending the time
people with advanced lung cancer live without their disease
progressing following initial treatment with chemotherapy,� said
Hal Barron, M.D., Genentech�s senior vice president, Development
and chief medical officer.
Both the U.S. and EU submissions are based on a pivotal Phase
III placebo-controlled, randomized, double-blind trial known as
SATURN. In November 2008, OSI, Genentech and Roche announced that
SATURN met its primary endpoint and showed that Tarceva
significantly extended the time patients with advanced NSCLC lived
without their cancer getting worse (progression-free survival or
PFS) when given immediately following initial treatment with
platinum-based chemotherapy, compared to placebo. There were no new
or unexpected safety signals in the study and adverse events were
consistent with those observed in previous NSCLC clinical trials
evaluating Tarceva.
The SATURN data will be presented at the 45th Annual Meeting of
the American Society of Clinical Oncology being held May 29-June 2,
2009 in Orlando, Fla. Overall survival data, a secondary endpoint
of the study, are expected in the second half of 2009 and will be
part of the FDA review process.
Additional Information about
SATURN
The SATURN study, conducted by Roche, enrolled 889 patients with
advanced NSCLC at approximately 160 sites worldwide. Patients were
treated with at least four cycles of standard first-line
platinum-based chemotherapy and were then randomized to Tarceva or
placebo if their cancer did not progress. The primary endpoint of
the study was progression-free survival. Secondary endpoints
included overall survival, safety and an evaluation of exploratory
biomarkers.
About Lung
Cancer
According to the American Cancer Society (ACS), lung cancer is
the single largest cause of cancer death among men and women in the
U.S. and nearly 162,000 Americans died from the disease in 2008.
Most people with lung cancer are diagnosed with advanced stage
disease that cannot be surgically removed or has spread to other
parts of the body. The majority of people with advanced lung cancer
survive less than one year. NSCLC is the most common type of lung
cancer.
About Tarceva
Tarceva is a small molecule designed to target the EGFR pathway,
which is one of the factors critical to cell growth in NSCLC and
pancreatic cancers. Tarceva is designed to inhibit the tyrosine
kinase activity of the EGFR signaling pathway inside the cell.
Tarceva is FDA-approved for use as a monotherapy in patients
with locally advanced or metastatic NSCLC whose disease has
progressed after one or more courses of chemotherapy. Results from
two, multicenter, placebo-controlled, randomized, Phase III trials
conducted in first-line patients with locally advanced or
metastatic NSCLC showed no clinical benefit with the concurrent
administration of Tarceva with platinum-based chemotherapy
(carboplatin and paclitaxel or gemcitabine and cisplatin) and its
use is not recommended in that setting.
Tarceva is also approved in combination with gemcitabine for the
treatment of patients who have not received previous chemotherapy
for locally advanced pancreatic cancer, pancreatic cancer that
cannot be surgically removed or pancreatic cancer that has spread
to distant body organs.
Tarceva Safety
In clinical studies, there were infrequent reports of serious
lung injuries similar to Interstitial Lung Disease (ILD)-like
events including deaths. Liver and/or kidney problems (including
deaths) have been reported in some patients taking Tarceva.
Patients receiving Tarceva plus gemcitabine were more likely to
experience bleeding and clotting problems such as heart attack or
stroke. Women should avoid becoming pregnant and avoid
breastfeeding while taking Tarceva. Patients taking Tarceva have
experienced new or worsening skin rash; serious or ongoing
diarrhea, nausea, loss of appetite, or vomiting; new or worsening
shortness of breath or cough; fever; eye irritation. Patients
should stop smoking while taking Tarceva. 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 personalized 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.
About Genentech
Founded more than 30 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines for patients with significant unmet
medical needs. The company has headquarters in South San Francisco,
California and is listed on the New York Stock Exchange under the
symbol DNA. For additional information about the company, please
visit http://www.gene.com.
OSI Safe Harbor Statement
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.
Genentech Safe Harbor Statement
This press release contains forward-looking statements regarding
the potential for Tarceva and approval for Tarceva in the
first-line maintenance setting for NSCLC. Such statements are
predictions and involve risks and uncertainties such that actual
results may differ materially. Actual results may be affected by a
number of factors including, but not limited to, unexpected safety,
efficacy or manufacturing issues, the need for additional data,
data analysis or clinical studies, NDA preparation, FDA actions or
delays, failure to obtain or maintain FDA approval, competition,
pricing, reimbursement, the ability to supply product, product
withdrawals and new product approvals and launches, and
intellectual property or contract rights. Please also refer to the
risk factors described in Genentech's periodic reports filed with
the Securities and Exchange Commission. Genentech disclaims, and
does not undertake, any obligation to update or revise any
forward-looking statement in this press release.
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