OSI Pharmaceuticals Announces That Tarceva® Received Approval in the European Union for Maintenance Use in Advanced Non-Smal...
29 Abril 2010 - 2:15AM
Business Wire
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that
its international partner for Tarceva® (erlotinib), Roche, received
approval from the European Commission for Tarceva as a monotherapy
maintenance treatment in patients with advanced non-small cell lung
cancer (NSCLC) whose disease remains largely unchanged (stable
disease) after platinum-based initial chemotherapy.
“We are pleased that the European health authorities recognize
Tarceva as a valuable option for lung cancer patients and their
physicians when used in the first-line maintenance setting,” said
Colin Goddard, Ph.D., Chief Executive Officer of OSI
Pharmaceuticals. “We look forward to working with our partner,
Roche, to advance the robust Tarceva lifecycle program, which
includes evaluating Tarceva in the adjuvant setting and as a
first-line treatment for advanced NSCLC patients with an activating
EGFR mutation as well as branching into other disease settings
including liver cancer.”
OSI previously announced on April 16, 2010 that the U.S. Food
and Drug Administration (FDA) approved Tarceva as a maintenance
treatment for patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) whose disease has not progressed
after four cycles of platinum-based first-line chemotherapy.
Tarceva is now approved in 109 countries for advanced NSCLC and 80
countries for pancreatic cancer.
About SATURN
The EU approval was based on data from the pivotal Phase III
SATURN study. 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.
SATURN showed that Tarceva given as a maintenance therapy
immediately after first-line chemotherapy significantly extended
overall survival (OS) and significantly improved the time people
with advanced NSCLC lived without the disease getting worse
(progression-free survival, PFS) in a broad patient population,
including squamous and non-squamous histology, compared with
placebo.
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 not grown or spread
after initial treatment with certain types of chemotherapy. Tarceva
is also prescribed for people with advanced-stage NSCLC whose
cancer has not grown or spread 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 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. Difficulty with blood clotting, and
bleeding events, including gastrointestinal and
non-gastrointestinal bleeding, have been reported in clinical
studies. 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 studies. 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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