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FDA Approves Tarceva (Erlotinib) Tablets and Cobas EGFR Mutation Test for Specific Type of Lung Cancer



  FDA Approves Tarceva (Erlotinib) Tablets and Cobas EGFR Mutation Test for
  Specific Type of Lung Cancer

    – Tarceva is the First Personalized Medicine Approved for the Initial
 Treatment of People with EGFR Mutation-Positive Advanced Non-Small Cell Lung
                        Cancer in the United States –

Business Wire

SOUTH SAN FRANCISCO, Calif. & NORTHBROOK, Ill. -- May 14, 2013

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and
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 approved Tarceva^® (erlotinib) tablets for the
initial (first-line) treatment of people with metastatic non-small cell lung
cancer (NSCLC) whose tumors have certain epidermal growth factor receptor
(EGFR) activating mutations as detected by an FDA-approved test. The FDA also
approved the cobas^® EGFR Mutation Test, which was developed by Roche and
validated in the pivotal EURTAC study. In the study, treatment with Tarceva
demonstrated that patients lived longer without their disease getting worse
(median progression-free survival [PFS] 10.4 months vs. 5.2 months; HR=0.34;
p<0.001 [95 percent CI 0.23 to 0.49]) compared to chemotherapy. The safety
profile for Tarceva in the EURTAC study was consistent with previous studies
of Tarceva in NSCLC.

“Ten to 30 percent of people worldwide with lung cancer have tumors that test
positive for certain EGFR mutations,” said Hal Barron, M.D., chief medical
officer and head, Genentech Global Product Development. “People with this type
of lung cancer now have the option to use a personalized medicine as their
initial treatment to help them live longer without their disease worsening.”

“With this approval, more patients across all lines of therapy have access to
Tarceva,” said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma
Inc. “This new indication is emblematic of Astellas’ commitment to continue
our development efforts in lung cancer and precision medicine.”

“Increasingly, doctors and patients rely on diagnostics to help guide
personalized treatment decisions. The approval of the cobas EGFR Mutation Test
highlights the importance of sensitive, accurate tests that can be conducted
in time to inform crucial treatment decisions,” said Paul Brown, head of Roche
Molecular Diagnostics. “At Roche, we have a deep commitment to providing
personalized healthcare options and are currently developing companion
diagnostics for more than half of the medicines in our pipeline.”

In the United States, Tarceva is already approved, irrespective of histology
or biomarker status for people with advanced-stage 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-stage NSCLC whose cancer has spread or grown after receiving at least
one chemotherapy regimen (second- or third-line treatment). Tarceva is not
meant to be used at the same time as certain types of chemotherapy for
advanced NSCLC.

This latest FDA approval for Tarceva is based on the results of the Phase III
EURTAC study, which evaluated the first-line use of Tarceva versus
platinum-based chemotherapy in people with EGFR-activating mutation-positive
advanced NSCLC. Tumor shrinkage (response rate) was observed in 65 percent of
patients treated with Tarceva and 16 percent of patients treated with
chemotherapy. The most frequent (greater than or equal to 30 percent) adverse
events in Tarceva-treated patients were diarrhea, weakness, rash, cough,
shortness of breath and decreased appetite. The most frequent Grade 3-4
reactions in Tarceva-treated patients were rash and diarrhea.

About the EURTAC Study

  * EURTAC (European Randomized Trial of Tarceva versus Chemotherapy) was
    designed and sponsored by the Spanish Lung Cancer Group (SLCG) and
    conducted in Spain, France and Italy in cooperation with Roche.
  * The cobas EGFR Mutation Test was used to confirm people with mutations
    (exon 19 deletion or exon 21 [L858R] substitution) in the EGFR gene.
  * From February 2007 to January 2011, 174 patients mostly of European
    descent were randomly assigned to receive Tarceva or platinum-based
    chemotherapy. The primary endpoint was investigator-assessed PFS.
  * Randomization was stratified by certain EGFR mutations and ECOG
    performance status (0 vs. 1 vs. 2).
  * The safety profile for Tarceva in the EURTAC study was consistent with
    previous studies of Tarceva in NSCLC.
  * The most frequent (greater than or equal to 30 percent) adverse events in
    Tarceva-treated patients were diarrhea, weakness, rash, cough, shortness
    of breath and decreased appetite. The most frequent Grade 3-4 reactions in
    Tarceva-treated patients were rash and diarrhea.

About Lung Cancer

According to the American Cancer Society, it is estimated that more than
228,000 Americans will be diagnosed with lung cancer in 2013, 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 surface. 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 cobas EGFR Mutation Test

The cobas EGFR Mutation Test is a real-time, polymerase chain reaction-based
diagnostic test for the qualitative detection and identification of exon 19
deletion or exon 21 (L858R) substitution mutations in the EGFR gene in DNA
derived from formalin-fixed, paraffin-embedded tumor (FFPET) tissue from NSCLC
patients. The test is intended to be used to identify patients with advanced
NSCLC whose tumors harbor these certain types of mutations.

About Genentech Access Solutions

Genentech is committed to people having access to our medicines. Genentech
Access Solutions is a team of more than 350 Genentech employees who help those
who need our medicines. Our knowledgeable and experienced specialists can help
patients and medical practices navigate the access and reimbursement process
and provide assistance to eligible patients in the United States who do not
have insurance coverage or who cannot afford their out-of-pocket co-pay costs.
For more information, please visit http://www.Genentech-Access.com.

About Tarceva

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of
advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein
involved in the growth and development of cancers. 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.

Tarceva Indications in NSCLC

First-Line, Maintenance Therapy, and Second- or Third-Line Therapy in Advanced
Non-Small Cell Lung Cancer (NSCLC):

  * Tarceva is prescribed as initial treatment for patients with NSCLC, whose
    cancer has spread to other parts of the body,that has certain types of
    Epidermal Growth Factor Receptor (EGFR) mutations. (First-line treatment)
  * Tarceva is prescribed for patients with advanced-stage non-small cell lung
    cancer (NSCLC) whose cancer has not spread or grown after initial
    treatment with certain types of chemotherapy. (Maintenance treatment)
  * Tarceva is prescribed for patients with advanced-stage (NSCLC) whose
    cancer has spread or grown after receiving at least 1 chemotherapy
    regimen. (Second/Third-line treatment)

Limitations of Use

  * Tarceva is not meant to be used at the same time as certain types of
    chemotherapy for advanced NSCLC.
  * For Initial treatment with NSCLC whose cancer has not spread to other
    parts of the body, it is not known if Tarceva is safe and effective in
    other EGFR mutations.

Important Safety Information

The following serious adverse reactions, which may include deaths, were
reported in patients taking Tarceva: Interstitial Lung Disease (ILD)-like
events; Liver and/or kidney problems; Gastrointestinal (GI) perforations (the
development of a hole in the stomach, small intestine, or large intestine);
Serious skin conditions; Bleeding and clotting problems (Heart attack or
stroke); Eye disorders (eye irritation and damage to the cornea); Bleeding
events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs);
Pregnancy (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:

Serious or ongoing diarrhea, nausea, loss of appetite, or vomiting; New or
worsening shortness of breath or cough; Eye irritation; New or worsening skin
rash, blistering or skin peeling; Any changes in smoking habits.

The most common, but less serious side effects include:

First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of
breath, and loss of appetite.

Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.

Report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch.

Patients and caregivers may also report side effects to Genentech at (888)
835-2555.

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

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 http://www.astellas.us.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco,
California. For additional information about the company, please visit
http://www.gene.com.

Contact:

Genentech
Media:
Holli Dickson, 650-467-6800
or
Advocacy:
Jen Mills, 650-467-6722
or
Investors:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
or
Astellas
Media:
Jenny Kite, 224-205-5405
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