AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

  AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for
  the Treatment of Advanced Renal Cell Carcinoma

     Oncologic Drugs Advisory Committee Meeting Scheduled for May 2, 2013

Business Wire

CAMBRIDGE, Mass. & NORTHBROOK, Ill. -- February 27, 2013

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Global Development, Inc., a
U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today
announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs
Advisory Committee (ODAC) will review the company's New Drug Application (NDA)
for tivozanib for the treatment of patients with advanced renal cell carcinoma
(RCC) during the morning session of its meeting on May 2, 2013. ODAC reviews
and evaluates data concerning the safety and effectiveness of marketed and
investigational human drug products for use in the treatment of cancer, and
makes recommendations to the Commissioner of Food and Drugs. According to the
timelines established by the Prescription Drug User Fee Act (PDUFA), the
review of the NDA is expected to be complete by July 28, 2013.

In November 2012, AVEO and Astellas announced that the FDA accepted for filing
the NDA for tivozanib with the proposed indication for the treatment of
patients with advanced RCC. The NDA includes results of the global Phase 3
TIVO-1 (TIvozanib Versus sOrafenib in 1^st line advanced RCC) trial, a
randomized superiority-designed pivotal trial evaluating the efficacy and
safety of tivozanib compared to sorafenib, an approved targeted agent, in 517
patients with advanced RCC, as well as data from 16 additional AVEO-sponsored
studies involving over 1,000 subjects who received tivozanib. Tivozanib is an
investigational medicine and is not currently approved in any country.

About Tivozanib

Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor
for which positive results from a Phase 3 clinical study in advanced RCC have
been reported, and is being evaluated in other tumors.

About Kidney Cancer

Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed cancer in
men and women in the U.S.^1 Worldwide it is estimated that more than 250,000
people are diagnosed and more than 100,000 people die from the disease each
year.^2 RCC accounts for more than 90 percent of all kidney cancers.^3

About the AVEO/Astellas Collaboration

In February 2011, AVEO and Astellas entered into a worldwide agreement to
develop and commercialize tivozanib outside of Asia for the treatment of a
broad range of cancers. Subject to regulatory approval, AVEO will lead
commercialization of tivozanib in North America and Astellas will lead
commercialization of tivozanib in the European Union (EU).

About Astellas

Astellas Pharma Global Development, 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 ofpeople 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.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to
discovering, developing and commercializing targeted therapies to impact
patients' lives. AVEO's proprietary Human Response Platform^TM provides the
company unique insights into cancer biology and is being leveraged in the
discovery and clinical development of its cancer therapeutics. For more
information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995 that involve substantial
risks and uncertainties. All statements, other than statements of historical
facts, contained in this press release are forward-looking statements. The
words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“target,” “potential,” “could,” “should,” “seek,” or the negative of these
terms or other similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among others,
statements about: the planned launch and commercialization of tivozanib; the
potential approval by the FDA of tivozanib in advanced RCC; the targeted dates
for the FDA’s ODAC meeting to review the NDA and the completion of the FDA’s
review of the NDA; tivozanib’s safety and efficacy profile and its potential
in treating patients with kidney cancer; and AVEO’s plans to leverage its
Human Response Platform™. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in the forward-looking
statements that AVEO makes due to a number of important factors, including
risks relating to: whether the results of AVEO’s Phase 3 TIVO-1 trial are
sufficient to obtain marketing approval for tivozanib, which turns on the
ability of AVEO to demonstrate to the satisfaction of the FDA or comparable
foreign regulatory authorities the safety and efficacy of tivozanib based upon
the findings of TIVO-1, including its data with respect to PFS, the rate of
adverse events, overall survival and other information that the FDA may
determine to be relevant to approvability; AVEO’s ability to demonstrate in
subsequent trials any safety and efficacy it demonstrated in earlier trials of
tivozanib; ongoing regulatory requirements with respect to the approval of
tivozanib, including the risk that the FDA or any comparable foreign
regulatory agency could require additional positive clinical trials as the
basis for product approval; AVEO’s ability to obtain and maintain adequate
protection for intellectual property rights relating to its product candidates
and technologies; unplanned operating expenses; AVEO’s ability to raise the
substantial additional funds required to achieve its goals; adverse general
economic and industry conditions; competitive factors; AVEO’s ability to
maintain its collaboration with Astellas; AVEO’s and Astellas’ ability to
successfully launch and commercialize tivozanib if and when it may be approved
for commercialization; and those risks discussed in the section titled “Risk
Factors” and elsewhere in AVEO’s current report on Form 8-K filed with the SEC
on January 16, 2013 and in its other filings with the Securities and Exchange
Commission. The forward-looking statements in this press release represent
AVEO’s views as of the date of this press release. AVEO anticipates that
subsequent events and developments will cause its views to change. However,
while AVEO may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as representing AVEO’s
views as of any date subsequent to the date of this press release.

^1U.S. Cancer Statistics Working Group. United States Cancer Statistics:
1999–2009 Incidence and Mortality Web-based Report. Atlanta: U.S. Department
of Health and Human Services, Centers for Disease Control and Prevention and
National Cancer Institute; 2013. Available at: ^www.cdc.gov/uscs^.

^2Cancer Research UK. Available at:
^http://info.cancerresearchuk.org/cancerstats/world/the-global-picture/#Common^;
^http://publications.cancerresearchuk.org/downloads/Product/cs_pdf_worldwide_2011.pdf

^3American Cancer Society. Available at: ^
http://www.cancer.org/Cancer/KidneyCancer/OverviewGuide/kidney-cancer--adult--
renal-cell-carcinoma-overview-what-is-kidney-cancer^.

Contact:

AVEO Oncology
Investor Contact:
Monique Allaire, 617-299-5810
or
Media Contacts:
AVEO Oncology
Rob Kloppenburg, 617-930-5595
or
Astellas US LLC
Jenny Kite, 224-205-5405
 
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