OSI Pharmaceuticals Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. Food & Drug Admi...
16 June 2009 - 1:18AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for filing
and review the supplemental New Drug Application (sNDA) for the use
of Tarceva� (erlotinib) as a first-line maintenance treatment for
patients with advanced non-small cell lung cancer (NSCLC) who have
not progressed following first-line treatment with platinum-based
chemotherapy. Based upon the March 17th receipt of filing the FDA
Prescription Drug Fee Act (PDUFA) review date will be on or about
January 18, 2010.
�We are pleased with the FDA�s decision to review the data to
evaluate Tarceva as a first-line maintenance therapy,� stated Colin
Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals.
�This decision puts us one step closer toward accomplishing our
goal of making Tarceva available earlier in the course of lung
cancer treatment, offering a non-chemotherapy choice for all NSCLC
patients in the maintenance setting.�
The sNDA filing is based on a pivotal Phase III
placebo-controlled, randomized, double-blind trial known as SATURN.
On May 14, 2009, OSI announced data from the SATURN study, which
was formally presented at the 45th Annual Meeting of the American
Society of Clinical Oncology on May 31, 2009 in Orlando, Fla.
About SATURN
SATURN is an international, placebo-controlled, randomized,
double-blind, Phase III study conducted by Roche 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 were then randomized to Tarceva
(150 mg) or placebo if their cancer did not progress. The primary
endpoint of the study was progression-free survival in the overall
population, as determined by investigators, and was defined as the
length of time from randomization to disease progression or death
from any cause. The co-primary endpoint was PFS in patients with
EGFR positive tumors by IHC. Secondary endpoints included overall
survival, safety and an evaluation of exploratory biomarkers,
including EGFR mutations and K-ras mutations.
The study met both of its co-primary endpoints by demonstrating
a statistically significant 41% improvement in the time patients
live without their disease worsening (as measured by progression
free survival, or PFS) compared with placebo (Hazard Ratio = 0.71,
p-value
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