Astellas Pharmaceuticals Inc.
) recently announced that the US Food and Drug Administration
(FDA) has accepted its supplemental new drug application (sNDA)
for Tarceva (erlotinib). Astellas is looking to expand the label
of Tarceva to first-line use in patients suffering from locally
advanced or metastatic non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) activating
mutations. Tarceva is currently approved and marketed for
maintenance therapy and second- or third-line therapy in advanced
Non-Small Cell Lung Cancer (NSCLC).
FDA will review the application on a priority basis. Priority
review status means that a response from the agency will be out
in six months instead of the usual 10 month review period. The US
regulatory authority generally reviews those drugs on a priority
basis, which offer major advances in treating diseases that do
not have adequate therapy. As such, a response from the FDA
should be out in second quarter of 2013.
The application was submitted on the basis of data from
an international trial, EURTAC (European Randomised Trial of
Tarceva vs. Chemotherapy), which was designed and sponsored by
the Spanish Lung Cancer Group (SLCG) and conducted in Spain,
France and Italy in cooperation with Roche Holding AG (
). The study evaluated the first-line use of Tarceva versus
platinum based chemotherapy in patients with EGFR activating
mutation-positive advanced NSCLC.
Astellas stated in its press release that 10% patients in
western countries with lung cancer and 30% patients in Asian
countries with lung cancer have EGFR activating mutations. We
believe the successful label expansion of Tarceva will increase
its sales potential.
According to Astellas over 226,000 Americans were diagnosed
with lung cancer, and NSCLC accounted for 85% of all lung cancers
in 2012. Around 60% was diagnosed in the advanced stages.
Astellas carries a Zacks Rank #4 (Sell). Right now Valeant
Pharmaceuticals International, Inc. (
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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