) recently announced that the US Food and Drug Administration
(FDA) has approved Tarceva (erlotinib) tablets for the first line
treatment of patients suffering from metastatic non-small cell
lung cancer (NSCLC).
Tarceva can now be used to treat patients suffering from NSCLC
with tumors that have certain epidermal growth factor receptor
(EFGR) activating mutations as detected by an FDA-approved
The FDA approval for Tarceva was based on the phase III EURTAC
study wherein the first-line use of Tarceva was evaluated
vis-à-vis platinum-based chemotherapy in patients with
EGFR-activating mutation-positive advanced NSCLC.
The study showed that 65% of patients treated with Tarceva
experienced tumor shrinkage as compared to 16% of patients
treated with chemotherapy. In addition, Roche got FDA approval
for its cobas EFGR Mutation Test which was validated in the
pivotal EURTAC study.
We note that Tarceva is already approved in the US for the
treatment of advanced-stage NSCLC in patients whose cancer has
not spread or grown after initial treatment with certain types of
chemotherapy (maintenance treatment).
The drug is also approved for treating patients suffering from
advanced-stage NSCLC whose cancer has spread or grown even after
being treated with at least one chemotherapy regimen.
The approval for the new indication should boost the sales
potential of the drug.
Tarceva was approved in Europe in 2012 for the first-line
treatment of NSCLC with EGFR activating mutations where it
primarily faces competition from
Roche has a global development and marketing alliance with
Astellas Pharma Inc.
) for Tarceva.
Roche currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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