Special Notices
Tarceva Approved for Advanced Non-small Cell Lung Cancer
Patients
On Friday November 19, 2004, the Food and Drug Administration
(FDA) announced its approval of Tarceva (erlotnib) for the treatment of advanced
non-small cell lung cancer (NSCLC). Tarceva is being approved as a treatment
for patients whose cancer has continued to progress despite other treatments,
including at least one prior chemotherapy regimen.
The FDA based its approval
on a Phase III clinical trial, which compared Tarceva with placebo
in patients with advanced stage non-small cell lung cancer who had already
received chemotherapy. Tarceva was shown to extend survival rates and lessen
symptoms associated with the disease.
Tarceva was developed through
partnerships with OSI Pharmaceuticals and Genentech. It is one of a
new class of cancer treatments that blocks the epidermal growth factor signal,
which promotes cell growth. It is expected to be available to patients before
the end of the month.
For more information, please visit the following links.
News Releases
Genentech and OSI Pharmaceuticals
News stories
Insurance Coverage of Tarceva
Private:
Many of the large private insurance companies are expected to cover
some portion of Tarceva. You should check with your insurance company to determine
coverage.
Medicare:
A pilot program (known as the Medicare Replacement Drug Demonstration Project) offers coverage of some oral cancer drugs including Iressa and
Tarceva.
Access to Care, Tarceva Trial:
With the FDA approval of Tarceva, the Access to Care, Tarceva Trial
(ACT Trial) will be closed to further patient enrollment. However,
patients already enrolled in this study will be followed for up to nine
additional months after Tarceva's approval to evaluate the survival
duration and response rate of NSCLC patients receiving Tarceva in
relationship to their prior tobacco use.
Genentech's Access to Care Foundation:
Although Genentech's products are covered by most government and private
insurance, Genentech has established the Access to Care Foundation for
each of its marketed products to make them available to qualified uninsured
or under-insured patients in the United States. In 2003, more than 4,200
patients participated in the program and the Access to Care Foundation
provided more than $41 million worth of drugs to patients in need, keeping
the company's promise that no one will go without a Genentech product based
on financial reasons alone. For more information on the Genentech® Access
to Care Foundation, please call (800) 530-3083.
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