Osi Pharmaceuticals (NASDAQ:OSIP)
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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.