OSI Pharmaceuticals Announces That Tarceva® Received a Positive Opinion from Health Authorities in the European Union for Fi...
March 19 2010 - 6:50AM
Business Wire
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that
its international partner for Tarceva® (erlotinib), Roche, informed
OSI that the European Committee for Medicinal Products for Human
Use (CHMP) has issued a positive opinion recommending approval of
Tarceva as monotherapy for maintenance treatment in patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC)
with stable disease following four cycles of standard
platinum-based first-line chemotherapy. A final decision is
expected from the European Commission within 45 days.
“Advanced lung cancer is an aggressive disease and when the
cancer grows or spreads the health of patients deteriorates
rapidly. By giving Tarceva earlier after chemotherapy, instead of
waiting for the disease to progress, we could help more people live
longer without their disease getting worse,” said Professor
Federico Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital,
Italy and principal investigator of the SATURN trial.
The CHMP positive opinion is based on a review of data from the
pivotal Phase III SATURN study which showed a statistically
significant improvement in both progression-free survival (PFS) and
overall survival (OS)- the study’s primary and secondary endpoints,
respectively- with Tarceva compared to placebo across a broad range
of patients with advanced NSCLC in the maintenance setting. The
magnitude of the benefit was greater in patients with stable
disease following first-line chemotherapy compared to patients
achieving a complete or partial response. Data for patients with
stable disease will be presented at a forthcoming scientific
meeting.
The U.S. Food and Drug Administration (FDA) recently extended
the review period for the supplemental New Drug Application (sNDA)
for Tarceva as a first-line maintenance therapy in advanced NSCLC
by 90 days, and the agency is now expected to make a decision by
April 18, 2010.
Sales of Tarceva outside the U.S. represent an important
component of the Company's revenues. In 2009, $146 million (or 41%)
of the Company's $359 million in Tarceva-related revenues were
derived from royalty payments received from Roche for sales outside
the U.S. market.
About SATURN
SATURN was an international, placebo-controlled, randomized,
double-blinded, Phase III study that enrolled 889 patients with
advanced NSCLC at approximately 160 sites worldwide. Patients were
treated with four cycles of standard first-line platinum-based
chemotherapy and then randomized to Tarceva or placebo if the
cancer did not progress. The co-primary endpoints were
progression-free survival (PFS) in all patients and PFS in patients
whose tumors over-expressed the epidermal growth factor receptor
(EGFR) as assessed by Immunohistochemistry (IHC). PFS was defined
as the length of time from randomization to disease progression or
death from any cause. Secondary endpoints included overall
survival, safety and an evaluation of exploratory biomarkers.
About Lung
Cancer
Lung cancer is the most common cancer worldwide with 1.5 million
new cases annually and NSCLC accounts for almost 85% of all lung
cancers. NSCLC progresses rapidly; less than 5% of advanced NSCLC
patients survive for five years.
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 cancer cell, one of the critical
growth factors in NSCLC and pancreatic cancer. The way Tarceva
works to treat cancer is not fully known. Tarceva is
prescribed for patients with advanced-stage NSCLC whose cancer
has spread or grown after receiving at least one chemotherapy
regimen. Tarceva is not meant to be used at the same time as
certain types of chemotherapy for NSCLC.
In pancreatic cancer, Tarceva in combination with gemcitabine is
prescribed for patients with advanced-stage pancreatic
cancer whose cancer has spread, grown, or cannot be
surgically removed, and who have not received previous
chemotherapy.
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 NSCLC
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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