-- Roche Submits Marketing Authorization Application for Approval of
Tarceva as a First-line Maintenance Therapy in Europe --
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Genentech, Inc., (NYSE:
DNA) today announced that OSI submitted a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) for
the use of Tarceva® (erlotinib) as a first-line maintenance
therapy for people with advanced non-small cell lung cancer (NSCLC) who
have not progressed following first-line treatment with platinum-based
chemotherapy. Additionally, the Companies announced that Roche, their
international collaborator for Tarceva, filed an application in Europe
with the European Medicines Agency (EMEA).
“If approved, Tarceva will be the first EGFR targeted and oral therapy
available as a first-line maintenance treatment for people with NSCLC,
which we believe is an important advancement in the treatment of lung
cancer,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI
Pharmaceuticals.
“The FDA application reflects our goal of extending the time people with
advanced lung cancer live without their disease progressing following
initial treatment with chemotherapy,” said Hal Barron, M.D., Genentech’s
senior vice president, Development and chief medical officer.
Both the U.S. and EU submissions are based on a pivotal Phase III
placebo-controlled, randomized, double-blind trial known as SATURN. In
November 2008, OSI, Genentech and Roche announced that SATURN met its
primary endpoint and showed that Tarceva significantly extended the time
patients with advanced NSCLC lived without their cancer getting worse
(progression-free survival or PFS) when given immediately following
initial treatment with platinum-based chemotherapy, compared to placebo.
There were no new or unexpected safety signals in the study and adverse
events were consistent with those observed in previous NSCLC clinical
trials evaluating Tarceva.
The SATURN data will be presented at the 45th Annual Meeting of the
American Society of Clinical Oncology being held May 29-June 2, 2009 in
Orlando, Fla. Overall survival data, a secondary endpoint of the study,
are expected in the second half of 2009 and will be part of the FDA
review process.
Additional Information about SATURN
The SATURN study, conducted by Roche, enrolled 889 patients with
advanced NSCLC at approximately 160 sites worldwide. Patients were
treated with at least four cycles of standard first-line platinum-based
chemotherapy and were then randomized to Tarceva or placebo if their
cancer did not progress. The primary endpoint of the study was
progression-free survival.
