Tarceva® (erlotinib) Endorsed by the U.K.’s National Institute for Health & Clinical Excellence for Use in Patients with A...
November 26 2008 - 6:38AM
Business Wire
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) welcomes today�s
announcement by the U.K.�s National Institute for Health and
Clinical Excellence (NICE) issuing Final Guidance recommending
funding by the National Health Service (NHS) for Tarceva�
(erlotinib) as an alternative treatment to the IV chemotherapy
agent docetaxel for the second-line treatment of advanced non-small
cell lung cancer (NSCLC). Tarceva is the first EGFR targeted agent
for advanced NSCLC recommended for use by NICE. With this action,
lung cancer patients in England, Wales and Northern Ireland will
now have access to an oral targeted therapy that has been approved
throughout Europe for advanced NSCLC. Tarceva is approved in 92
countries including the United States and the European Union as a
monotherapy for the treatment of patients with locally advanced or
metastatic NSCLC after failure of at least one prior chemotherapy
regimen. Tarceva is also approved in combination with gemcitabine
chemotherapy for the first-line treatment of locally advanced,
unresectable or metastatic pancreatic cancer in 68 countries
worldwide. 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 (at a
recommended dose of 150 mg/day). 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 locally advanced
or metastatic pancreatic cancer in patients who have not received
previous chemotherapy (at a recommended dose of 100 mg/day).
Tarceva Safety Profile There have been infrequent reports of
serious Interstitial Lung Disease (ILD)-like events, including
fatalities, in patients receiving Tarceva for treatment of NSCLC,
pancreatic cancer or other advanced solid tumors. Cases of hepatic
failure, hepatorenal syndrome, acute renal failure (all including
fatalities) and renal insufficiency have been reported during use
of Tarceva. In the pancreatic cancer trial, other serious adverse
reactions associated with Tarceva plus gemcitabine, and which may
have included fatalities, were myocardial infarction/ischemia,
cerebrovascular accident and microangiopathic hemolytic anemia with
thrombocytopenia. When receiving Tarceva therapy, women should be
advised against becoming pregnant or breastfeeding. Tarceva is
pregnancy category D. The most common adverse reactions in patients
with NSCLC receiving Tarceva monotherapy 150 mg were rash and
diarrhea. The most common adverse reactions in patients with
pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were
fatigue, rash, nausea, anorexia and diarrhea. 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
and novel pharmaceutical products designed to extend life and/or
improve the quality of life for patients with cancer and
diabetes/obesity. The Company�s oncology programs are focused on
developing molecular targeted therapies designed to change the
paradigm of cancer care. OSI�s diabetes/obesity efforts are
committed to the generation of novel, targeted therapies for the
treatment of type 2 diabetes and obesity. OSI's flagship product,
Tarceva� (erlotinib), is the first drug discovered and developed by
OSI to obtain FDA approval and the only EGFR inhibitor to have
demonstrated the ability to improve survival in both non-small cell
lung cancer and pancreatic cancer patients in certain settings. OSI
markets Tarceva through partnerships with Genentech, Inc. in the
United States and with Roche throughout the rest of the world. For
additional information about OSI, please visit . 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, the completion of clinical trials, the FDA
review process and other governmental regulation, OSI's and its
collaborators' abilities to successfully develop and commercialize
drug candidates, competition from other pharmaceutical companies,
the ability to effectively market products, and other factors
described in OSI Pharmaceuticals' filings with the Securities and
Exchange Commission.
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