SUTENT(R) Receives European Approval for a New Indication in Progressive Pancreatic Neuroendocrine Tumors (NET)

By Pfizer Inc., PRNE
Wednesday, December 1, 2010

First Targeted Therapy Approved for the Treatment of Pancreatic NET in Europe

NEW YORK, December 2, 2010 - Pfizer Inc. (NYSE: PFE) announced today that the European Commission has
approved SUTENT(R) (sunitinib malate) for the treatment of unresectable or
metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with
disease progression in adults. Experience with SUTENT as initial treatment is
limited in this disease. Pancreatic NET is a rare cancer reported in two to
four people per million annually worldwide.(1,2) Sutent is the first
treatment to be approved for patients with pancreatic NET in twenty-five

(Logo: )

The approval is based on results from a randomized, Phase 3 trial that
demonstrated SUTENT more than doubled the time period that patients were free
from disease progression or death. The progression-free survival (PFS) for
SUTENT was 11.4 months vs. 5.5 months for placebo (p=0.0001) in 171 patients.
Additionally, while the overall survival data were not mature at the time of
analysis, the overall survival favored the SUTENT arm compared with placebo
(9 vs. 21 deaths) (HR 0.409, p=0.0204).(4)

"This approval represents a significant milestone in the management of
pancreatic NET," said Dr. Mace Rothenberg, senior vice president of Clinical
Development and Medical Affairs, Pfizer Oncology Business Unit. "SUTENT has
been a standard of care for patients with advanced/metastatic renal cell
carcinoma (RCC) and imatinib-refractory gastrointestinal stromal tumor (GIST)
for several years, and we are proud that it is now a treatment option for
patients in Europe with progressive pancreatic NET."

Although rare, the reported incidence of pancreatic NET appears to be
rising,(2,5) accounting for approximately nine percent of neuroendocrine
tumors.(5) Current treatment options have limited therapeutic benefit and the
prognosis is poor for patients with advanced pancreatic NET.(6)

"As the first anti-VEGF therapy to show a substantial clinical benefit in
treating progressive pancreatic NET, SUTENT represents a novel therapeutic
approach for this difficult-to-treat disease." said Dr. Eric Raymond,
principal investigator of the pivotal Phase 3 study that led to the approval
of Sutent for pancreatic NET in Europe. "Physicians in Europe will now be
able to use a therapy with proven efficacy to treat this disease." Dr.
Raymond is professor of medical oncology and head of University Department of
Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon,
Clichy, France.

SUTENT is also approved for the treatment of unresectable
well-differentiated advanced and/or metastatic pancreatic neuroendocrine
carcinoma in the Philippines, Switzerland, Colombia and Korea. In addition,
it is under regulatory review for this indication in several other countries.

About Pancreatic Neuroendocrine Tumors

Tumors of the neuroendocrine system are typically classified into two
distinct categories: carcinoids or pancreatic neuroendocrine tumors.
Pancreatic neuroendocrine tumors, also known as pancreatic islet cell tumors,
form in the endocrine (hormone-producing) tissues of the pancreas.(7)
Subtypes include insulinomas, glucagonomas and gastrinomas. Pancreatic
neuroendocrine tumors are different from pancreatic adenocarcinoma, which
account for about 95 percent of all pancreatic cancers.(7)

About SUTENT((R)) (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor approved for the treatment of
advanced/metastatic renal cell carcinoma (RCC) and unresectable and/or
metastatic malignant gastrointestinal stromal tumor (GIST) after failure of
imatinib mesilate treatment due to resistance or intolerance. In Europe,
SUTENT is also indicated for the treatment of unresectable or metastatic,
well-differentiated pancreatic neuroendocrine tumors with disease progression
in adults. Experience with SUTENT as first-line treatment is limited

SUTENT works by blocking multiple molecular targets implicated in the
growth, proliferation and spread of cancer. Two important SUTENT targets,
vascular endothelial growth factor receptor (VEGFR) and platelet-derived
growth factor receptor (PDGFR), are expressed by many types of solid tumors
and are thought to play a crucial role in angiogenesis, the process by which
tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT
also inhibits other targets important to tumor growth, including KIT, FLT3
and RET.

Important SUTENT((R)) (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing
experience. Cases of hepatic failure, some with a fatal outcome, were
observed in <1% of solid tumor patients treated with SUTENT. It is
recommended to monitor liver function tests before initiation of treatment,
during each cycle of treatment, and as clinically indicated. If signs or
symptoms of hepatic failure are present, sunitinib should be discontinued and
appropriate supportive care should be provided.

Women of child bearing age who are (or become) pregnant during therapy
should be informed of the potential for fetal harm while on SUTENT.

Decreases in left ventricular ejection fraction (LVEF) to below the lower
limit of normal (LLN) have been observed. Patients with concomitant cardiac
conditions should be carefully monitored for clinical signs and symptoms of
congestive heart failure. Patients should be monitored for hypertension and
treated as needed with standard antihypertensive therapy. Complete blood
counts (CBCs) with platelet count and serum chemistries should be performed
at the beginning of each treatment cycle for patients receiving treatment
with SUTENT.

The most common adverse reactions in GIST, RCC and pancreatic NET
clinical trials were diarrhea, fatigue, asthenia, nausea,
mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension,
dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin
discoloration, hair color changes, altered taste and bleeding. For more
information on SUTENT and Pfizer Oncology, including full prescribing
information for SUTENT (sunitinib malate), please visit

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook for cancer
patients worldwide. Our strong pipeline, one of the most robust in the
industry, is studied with precise focus on identifying and translating the
best scientific breakthroughs into clinical application for patients across a
wide range of cancers. Pfizer Oncology has biologics and small molecules in
clinical development and more than 100 clinical trials underway. By working
collaboratively with academic institutions, individual researchers,
cooperative research groups, governments, and licensing partners, Pfizer
Oncology strives to cure or control cancer with breakthrough medicines, to
deliver the right drug for each patient at the right time. For more
information please visit

DISCLOSURE NOTICE: The information contained in this release is as of
December 2, 2010. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.

This release contains forward-looking information that involves
substantial risks and uncertainties about the pancreatic NET indication for
Sutent in countries in which that indication is under regulatory review. Such
risks and uncertainties include, among other things, decisions by regulatory
authorities in those countries regarding whether and when to approve
supplemental drug applications that have been filed for such indication as
well as their decisions regarding labeling and other matters that could
affect its availability or commercial potential; and competitive

A further description of risks and uncertainties can be found in Pfizer's
Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in
its reports on Form 10-Q and Form 8-K.

    (1) Ramage JK, Davies AHG, Ardill et al. Guidelines for the
    management of gastroenteropancreatic neuroendocrine (including
    carcinoid) tumors. Gut. 2005;54:iv1-16.
    (2) Halfdanarson TR, Rabe KG, Rubin J et al. Pancreatic
    neuroendocrine tumors (PNETs): incidence, prognosis and recent trend
    toward improved survival. Ann Oncol. 2008;19:1727-33
    (3) U.S. Food and Drug Administration. Drugs@FDA: Zanosar.
    Accessed November 17, 2010.
    (4) Niccoli, P., Raoul, J., Bang, Y., et al. Updated safety and
    efficacy results of the phase III trial of sunitinib (SU) vs placebo
    (PBO) for treatment of pancreatic neuroendocrine tumors (NET). ASCO
    (5) Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla
    EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years
    after "carcinoid": epidemiology of and prognostic factors for
    neuroendocrine tumors in 35,825 cases in the United States. J Clin
    Oncol. Jun 20 2008;26(18):3063-3072.
    (6) Yao JC, Eisner MP, Leary C, et al. Population-based study of
    islet cell carcinoma. Ann Surg Oncol. 2007;14(12):3492-3500.
    (7) National Cancer Institute. Islet Cell Tumors (Endocrine Pancreas)
    Treatment - Patient Version. Available at:
    Accessed January 5, 2010.

Media: Curtis Allen, +1-212-733-2096, +1-347-443-5252; or Investors: Jennifer Davis, +1-212-733-0717

will not be displayed