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.”