FDA Advisory Committee Recommends Against Approving Tarceva for First-Line Maintenance Use in Advanced Non-Small Cell Lung Ca...
December 16 2009 - 3:40PM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc., a
wholly owned member of the Roche Group (SIX: RO, ROG)(OTCQX:
RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one
recommending against approval of the daily pill Tarceva®
(erlotinib) for first-line maintenance use in people with advanced
or metastatic non-small cell lung cancer (NSCLC) whose cancer has
not progressed (grown or spread) following first-line treatment
with platinum-based chemotherapy. The FDA is not bound by the
recommendations of its advisory committees and the agency is
expected to make a decision whether to approve Tarceva for this use
by January 18, 2010.
“We are disappointed with the Committee’s recommendation and
will work diligently to respond to the issues that arose today as
quickly as possible,” said Colin Goddard, Ph.D., Chief Executive
Officer of OSI Pharmaceuticals. “We continue to believe that having
an oral, well-tolerated treatment option that can maintain the
initial benefit from cytotoxic chemotherapy would be an important
advance in treating advanced lung cancer and will explore further
with regulatory agencies how best to pursue this outcome.”
“We continue to hope Tarceva may be an option that could help
more people with advanced non-small cell lung cancer live longer
without the disease getting worse,” said Hal Barron, M.D.,
executive vice president, Global Development and chief medical
officer, Genentech. “We will work closely with OSI to carefully
review and address the Committee’s comments.”
The ODAC recommendation was based on a review of data from the
pivotal Phase III SATURN study which showed a statistically
significant improvement in both progression-free survival (PFS) and
overall survival (OS) with Tarceva compared to placebo in the NSCLC
maintenance setting. There were no new or unexpected safety signals
in the study and adverse events were consistent with those
previously reported for Tarceva in NSCLC.
- 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
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