Attached files
file | filename |
---|---|
8-K - FORM 8-K - OSI PHARMACEUTICALS INC | y84029e8vk.htm |
EX-99.1 - EX-99.1 - OSI PHARMACEUTICALS INC | y84029exv99w1.htm |
EX-99.2 - EX-99.2 - OSI PHARMACEUTICALS INC | y84029exv99w2.htm |
Exhibit 99.3
![]() |
NEWS RELEASE | |||||
OSI Contacts: | ||||||
Media/Investor: | Kathy Galante | (631)962-2043 | ||||
Media: | Kim Wittig | (631) 962-2135 | ||||
Representing OSI: | ||||||
Media: | ||||||
Joele Frank, Wilkinson Brimmer Katcher | ||||||
Joele Frank/Andy Brimmer/Eric Brielmann | ||||||
212-355-4449 | ||||||
Investors: | ||||||
Burns McClellan | ||||||
Lisa Burns | ||||||
212-213-0006 |
FDA APPROVES TARCEVA AS A MAINTENANCE THERAPY FOR ADVANCED NON-SMALL CELL LUNG CANCER
- First Maintenance Therapy Approved For a Broad Patient Population Including Squamous and Non-Squamous Histology -
MELVILLE, NEW YORK April 16, 2010 OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced
today that the U.S. Food and Drug Administration (FDA) approved the daily pill Tarceva®
(erlotinib) 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.
We are delighted that lung cancer patients and their physicians will have the option of beginning
Tarceva therapy in the first-line maintenance setting. We believe that Tarceva, as the only
medicine approved in the maintenance setting for the squamous and non-squamous forms of NSCLC,
offers a valuable treatment option for these patients, said Colin Goddard, Ph.D., Chief Executive
Officer of OSI Pharmaceuticals. We remain committed to a strategy of maximizing the value of
Tarceva as an important therapy for cancer patients and are pursuing the study of additional uses
for Tarceva, including as a first-line treatment for lung cancer patients with an activating EGFR
mutation, as an adjuvant therapy in NSCLC, and in other tumor types such as ovarian cancer and
hepatocellular carcinoma.
The new approval for Tarceva was based on data from the pivotal Phase III SATURN study. 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. The goal of maintenance therapy, a new approach in lung cancer, is to provide an active
treatment for patients whose disease either responded to, or was stable, following initial
chemotherapy before their cancer worsens. Many people are unable to receive further treatment
after their cancer grows or spreads because of rapid cancer growth and worsening symptoms.
Tarceva is already FDA-approved for people with advanced NSCLC whose cancer has grown or spread
after receiving at least one course of chemotherapy. Tarceva is not meant to be used at the same
time as certain types of chemotherapy for NSCLC.
According to the American Cancer Society, lung cancer is the leading cause of cancer death in the
United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most
common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to
five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.
About SATURN
SATURN was an international, placebo-controlled, randomized, double-blind, 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. PFS was defined as the length of time from
randomization to disease progression or death from any cause.
| OS was significantly improved by 23 percent with Tarceva compared to placebo (hazard ratio=0.81, 19 percent reduction in the risk of death, p=0.0088). | |
| People who received Tarceva had a 41 percent improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo (hazard ratio=0.71, 29 percent reduction in the risk of cancer progression or death, p<0.0001). | |
| The most commonly reported adverse events in patients who received Tarceva as maintenance therapy were rash (49 percent) and diarrhea (20 percent). Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively. There were no cases of Grade 4 rash or diarrhea. |
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.
In addition to its indications in advanced NSCLC, Tarceva is also prescribed in combination with
gemcitabine 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.
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, OSIs and its collaborators abilities to effectively market and sell Tarceva and to expand
the approved indications for Tarceva, OSIs ability to protect its intellectual property rights,
safety concerns regarding Tarceva, competition to Tarceva and OSIs drug candidates from other
biotechnology and pharmaceutical companies, the completion of clinical trials, the effects of FDA
and other governmental regulation, including pricing controls, OSIs ability to successfully
develop and commercialize drug candidates, and other factors described in OSI Pharmaceuticals
filings with the Securities and Exchange Commission.