FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
April 16 2010 - 7:35PM
Business Wire
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
Osi Pharmaceuticals (NASDAQ:OSIP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Osi Pharmaceuticals (NASDAQ:OSIP)
Historical Stock Chart
From Jul 2023 to Jul 2024
Real-Time news about Osi Pharmaceuticals Inc. (MM) (NASDAQ): 0 recent articles
More OSI Pharmaceuticals, Inc. News Articles