Astellas Submits Supplemental New Drug Application to FDA for Tarceva® as a First-Line Therapy in Genetically Distinct Form of

 Astellas Submits Supplemental New Drug Application to FDA for Tarceva® as a
First-Line Therapy in Genetically Distinct Form of Non-Small Cell Lung Cancer

PR Newswire

NORTHBROOK, Ill., Nov. 20, 2012

NORTHBROOK, Ill., Nov. 20, 2012 /PRNewswire/ --Astellas Pharma US, Inc.
("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), today announced it has submitted a supplemental New Drug Application
(sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for
Tarceva^® (erlotinib) tablets for first-line treatment of patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors
have epidermal growth factor receptor (EGFR) activating mutations as detected
by an approved test.

The sNDA submission is based on results of the international EURTAC trial, a
prospective, randomized, controlled Phase 3 trial evaluating the first-line
use of Tarceva versus platinum-based chemotherapy in patients with EGFR
activating mutation-positive advanced NSCLC.

A companion diagnostic, the cobas® EGFR Mutation Test developed by Roche
Molecular Diagnostics, to identify people with NSCLC whose tumors have EGFR
activating mutations is currently under review by the Center for Devices and
Radiological Health (CDRH) to support the EURTAC sNDA. It is estimated that as
many as one in ten (10 percent) people in Western populations with lung cancer
and three in ten (30 percent) Asian people with lung cancer have EGFR
activating mutations.

About the EURTAC Study

  oEURTAC (European Randomised Trial of Tarceva vs. Chemotherapy) was
    designed and sponsored by the Spanish Lung Cancer Group (SLCG) and
    conducted in Spain, France and Italy in cooperation with Roche.
  oFrom February 2007 to January 2011, 174 predominantly Caucasian patients
    were randomly assigned to receive Tarceva or platinum-based chemotherapy.
    The primary endpoint was investigator-assessed progression-free survival
  oAn analysis of the EURTAC data, reflecting a total of 133 PFS events, is
    included in the submission to the FDA.
  oIn the 133 PFS event analysis, the median PFS was 10.4 months in the
    Tarceva group and 5.1 months in the platinum-based chemotherapy group.
    Tarceva reduced the risk of lung cancer getting worse by 66 percent
    (hazard ratio=0.34, p<0.0001).
  oThe safety profile for Tarceva in the EURTAC study was consistent with
    previous studies of Tarceva in NSCLC.
  oThe most frequent (> 10%) adverse events were diarrhea, asthenia, rash,
    cough, and dyspnea in the Tarceva group and asthenia, anemia, nausea,
    neutropenia and cough in the chemotherapy group.  Two patient deaths in
    the chemotherapy arm and two patient deaths in the Tarceva arm were
    reported as related to treatment.

About EGFR in Lung Cancer
EGFR is a protein that extends across the cell membrane. The epidermal growth
factor (EGF) binds to the part of the EGFR protein that sits on the outside of
the cell. Binding leads to activation of the EGFR protein which triggers a
complex signaling cascade inside the cell that leads to events including
accelerated cell growth and division and development of metastases  (tumor
growth and spread to other parts of the body). Some NSCLC tumors have
activating mutations in the EGFR gene, changing the structure of the EGFR
proteins such that they have increased activity.

Important Safety Information
There have been reports of serious Interstitial Lung Disease (ILD)-like events
including deaths in patients taking Tarceva. Serious side effects (including
deaths) in patients taking Tarceva include liver and/or kidney problems;
gastrointestinal (GI) perforations (the development of a hole in the stomach,
small intestine, or large intestine); severe blistering skin reactions
including cases similar to Stevens-Johnson syndrome; and bleeding events
including gastrointestinal and non-gastrointestinal bleeding when taking
warfarin or non-steroidal anti-inflammatory drugs (NSAIDs). Eye irritation
and damage to the cornea have been reported in patients taking Tarceva. Women
should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.
Patients should call their doctor right away if they have these signs or
symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea,
loss of appetite, vomiting, or stomach pain; new or worsening shortness of
breath or cough; fever; eye irritation. Rash and diarrhea were the most common
side effects associated with Tarceva in the advanced non-small cell lung
cancer clinical studies.

Report side effects to the FDA at (800) FDA-1088 or

Patients and caregivers may also report side effects to Genentech at (888)

For full prescribing information, please call 1-877-TARCEVA or

About Tarceva
Tarceva is approved for patients with advanced NSCLC whose cancer has not
spread or grown after initial treatment with certain types of chemotherapy
(maintenance treatment). Tarceva is also approved for patients with advanced
NSCLC whose cancer has spread or grown after receiving at least one
chemotherapy regimen (second-/third-line treatment). Tarceva is not meant to
be used at the same time as certain types of chemotherapy for NSCLC.

Tarceva is a trademark of OSI Pharmaceuticals, LLC, Farmingdale, NY, USA, an
affiliate of Astellas Pharma US, Inc. In the United States, Tarceva is
jointly marketed by Astellas and Genentech, a member of the Roche Group.

About Astellas
Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The organization
is committed to becoming a global category leader in oncology, and has several
oncology products on the market and compounds in development. Astellas is
proud to be an award recipient of the CEO Gold Standard Accreditation from the
CEO Roundtable on Cancer. For more information on Astellas Pharma Inc., please
visit our website at

SOURCE Astellas Pharma US, Inc.

Contact: Jenny M. Kite, +1-224-205-5405,
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