FDA Accepts Supplemental New Drug Application For Tarceva® (erlotinib) Tablets For Genetically Distinct Form Of Advanced Lung

FDA Accepts Supplemental New Drug Application For Tarceva® (erlotinib) Tablets
            For Genetically Distinct Form Of Advanced Lung Cancer

- The Tarceva application has been granted priority review -

PR Newswire

NORTHBROOK, Ill., Jan. 16, 2013

NORTHBROOK, Ill., Jan. 16, 2013 /PRNewswire/ --Astellas Pharma US, Inc.
("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), today announced that the U.S. Food and Drug Administration (FDA) has
accepted for filing a supplemental New Drug Application (sNDA) for Tarceva®
(erlotinib) for first-line use in people with locally advanced or metastatic
non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor
receptor (EGFR) activating mutations. The application has been granted
Priority Review status, and an FDA decision is expected in the second quarter
of 2013. A pre-market approval (PMA) application for a companion diagnostic,
the cobas® EGFR Mutation Test developed by Roche Molecular Diagnostics, has
also been submitted to the FDA.

"We are pleased the FDA granted an expedited six-month review of our
application because lung cancer is one of the most common and deadly cancers,"
said Stephen Eck, M.D., Ph.D., vice president, head of Medical Oncology,
Astellas Pharma Global Development, Inc. "We are proud of Tarceva's already
approved indications for the maintenance and relapsed advanced NSCLC settings.
If approved, people with a genetically distinct form of lung cancer could have
a potential new personalized medicine for use as a first-line treatment."

It is estimated that as many as one in 10 (10 percent) people in Western
populations with lung cancer and three in 10 (30 percent) Asian people with
lung cancer have EGFR activating mutations.

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.

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
    (PFS).

About Lung Cancer
In 2012, it was estimated that more than 226,000 Americans would be diagnosed
with lung cancer, and NSCLC accounts for 85 percent of all lung cancers. It is
estimated that approximately 60 percent of lung cancer diagnoses are made when
the disease is in the advanced stages.

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.

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.

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 GI and non-GI 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; or eye
irritation. Rash and diarrhea were the most common side effects associated
with Tarceva in the advanced NSCLC clinical studies.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Patients and caregivers may also report side effects to Genentech at (888)
835-2555.

For full prescribing information, please call 1-877-TARCEVA or visit
http://www.tarceva.com.

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 www.astellas.us.

SOURCE Astellas Pharma US, Inc.

Website: http://www.astellas.us
Contact: Jenny Kite, +1-224-205-5405
 
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