FDA Extends Review Period for Tarceva Application for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
January 15 2010 - 11:41AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc., a
wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) has extended the review period for the supplemental New Drug
Application (sNDA) for Tarceva® (erlotinib) as a first-line
maintenance therapy in advanced non-small cell lung cancer (NSCLC)
by an additional 90 days. The extension follows OSI’s submission of
further data in support of the application. The original
Prescription Drug User Fee Act (PDUFA) date was January 18, 2010.
The companies now anticipate FDA action on the sNDA by April 18,
2010.
OSI and Genentech will work closely with the FDA during this
extended review period.
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
According to the American Cancer Society, lung cancer is the
leading cause of cancer death in the United States. It is estimated
approximately 159,000 Americans died from the disease in 2009. 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 cancer cell, one of the critical
growth factors in NSCLC and pancreatic cancer. Tarceva is indicated
as a monotherapy for people 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.
Tarceva is also indicated in combination with gemcitabine
chemotherapy for the first-line treatment of people 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 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.
About Genentech
Founded more than 30 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. The company, a wholly owned
member of the Roche Group, has headquarters in South San Francisco,
California. 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.
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