FDA Panel Rejects Earlier Use of Tarceva In Lung Cancer
December 16 2009 - 2:55PM
Dow Jones News
A Food and Drug Administration panel Wednesday rejected earlier
use of the cancer drug Tarceva in patients with advanced lung
cancer.
Tarceva, co-marketed by OSI Pharmaceuticals Inc. (OSIP) and
Roche's (ROG.VX) Genentech unit, is currently approved to treat
non-small cell lung cancer after treatment with chemotherapy failed
to stop the spread of the disease. The drug is considered a
second-line therapy.
The companies are seeking FDA approval to use the drug
immediately after chemotherapy as a maintenance treatment in
patients whose disease remained stable after chemotherapy.
However, the panel of outside medical experts voted 1 to 12
against a question that asked if Tarceva should be approved for the
proposed indication as a first-line maintenance treatment. Tarceva
is an oral drug that blocks an enzyme involved with cancer
growth.
The companies conducted a study involving 889 patients with
advanced lung cancer who had completed four cycles of chemotherapy
without their disease progressing or getting worse. Half of the
patients were given Tarceva while the other half were given a
placebo or fake treatment. The study showed patients receiving
Tarceva had a median progression-free survival of 12.3 weeks, or
the time before the disease started getting worse, compared with
11.1 weeks for those on placebo.
The panel said the benefit of using Tarceva earlier in treatment
than currently called for was modest and that it wasn't clear
whether using the drug earlier was better than using the product
once lung cancer has started getting worse.
In a background document prepared for Wednesday's meeting, the
FDA said the study was successful at meeting its main goal.
However, the agency said the main issue for discussion during the
panel meeting is "other available treatment options."
The FDA said Tarceva, and another drug, Cocetaxel, have a median
survival of three months compared to placebo when given to patients
after chemotherapy has failed. Docetaxel is sold as Taxotere by
Sanofi Aventis SA (SNY).
"This raises the question whether treatment with single agent
erlotinib (Tarceva) or docetaxel after progression are better
options than treatment with erlotinib as maintenance," the FDA
said.
OSI said Tarceva provides "an important new therapeutic option"
when given immediately after chemotherapy.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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