Pfizer's Sutent(R) Is Granted Full Marketing Authorization for First-Line Use in Advanced Kidney Cancer in the European Union

New York (ots/PRNewswire) -

- Full marketing authorization and extension of indication to
first-line treatment of advanced and/or metastatic renal cell
carcinoma (MRCC)

- First multiple receptor tyrosine kinase inhibitor to be approved
in the EU for first-line use in MRCC

Pfizer Inc said today that Sutent(R) (sunitinib malate) has
received the European Commission's full marketing authorization for
the treatment of advanced and/or metastatic renal cell carcinoma
(MRCC), a type of advanced kidney cancer. It is the first multiple
receptor tyrosine kinase inhibitor to be approved in the EU for
first-line use in MRCC.

Sunitinib malate is an oral therapy belonging to a new class of
dual-action multi-targeted drugs that attack cancer by inhibiting
tumor growth and starving the tumor of blood, thereby reducing its
ability to continue to divide and grow.

Clinical Studies

The European Commission's full marketing authorization is based on
data from a large phase III MRCC trial. In this multicenter
international study, 750 patients received sunitinib malate or
interferon-alfa (IFN alfa), the current standard of care.

Patients taking sunitinib malate had prolonged progression-free
survival (PFS) in first-line treatment for MRCC.

- Patients in the sunitinib malate arm experienced 11-month median PFS
-- more than double the 5-month median PFS observed with IFN alfa.
- Sunitinib malate demonstrated a 5-fold higher objective response rate
(ORR) compared with IFN alfa in first-line MRCC treatment (28% vs. 5%).
- Sunitinib malate is generally well tolerated with fewer
discontinuations than IFN alfa. Fewer patients discontinued the
medicine because of treatment-related adverse events (6% vs. 9%).

"The study shows the benefits that Sutent can provide to
patients," said Professor Sylvie Negrier, Deputy Director of the
Centre Leon Berard, Lyon and Professor of Medicine at Lyon
University. "Doubling median progression-free survival compared to
the current standard treatment is a promising result, and confirms
Sutent's value for this devastating disease. As a physician who
regularly treats metastatic renal cell carcinoma, I am glad to be
able to offer my patients an effective new treatment."

Sunitinib malate's side effects in clinical studies for the
treatment of MRCC were generally mild or moderate. The most common
treatment-related adverse events of any grade were fatigue; GI
disorders -- diarrhea, nausea, stomatitis, dyspepsia, and vomiting;
skin discoloration; dysgeusia; and anorexia.

The most severe adverse events associated with sunitinib malate
vs. IFN alfa were decreased ejection fraction (2%), hand-foot
syndrome (5%), thrombocytopenia (6%), neutropenia (6%), and
hypertension (8%).

"Sutent has the potential to provide real improvements on the
current standard of care. With this first-line European approval,
these benefits can be extended to even more patients," said Dr.
Joseph Feczko, Pfizer's Chief Medical Officer.

In addition to its full authorization for the treatment of MRCC in
the EU, sunitinib malate is indicated for the treatment of
unresectable and/or metastatic malignant gastrointestinal stromal
tumors (GIST) after failure of imatinib mesylate treatment due to
resistance or intolerance.

Background on Sunitinib Malate's Full Marketing Authorization for
MRCC

Full approval of sunitinib malate for the treatment of MRCC
includes a broadening of the initial indications that the European
Commission conditionally authorized in July 2006. Based on results
from two phase II studies in cytokine refractory MRCC, the Commission
had granted Pfizer conditional marketing authorization in the EU. The
condition was that Pfizer would provide further data on the drug's
effect in terms of relevant clinical endpoints such as
progression-free survival (PFS). Following evaluation of clinical
data submitted by Pfizer, the European Medicines Agency (EMEA)
recommended removing the "conditional" status; it also recommended
extending the indication to first-line treatment of advanced and/or
metastatic RCC. The Commission has formally endorsed the
recommendations.

In the two phase II studies in cytokine-refractory MRCC, which
occurs when patients become resistant to cytokine therapy, a form of
immunotherapy, the objective response rates for sunitinib malate were
38% and 36%. While median overall survival in the first of these two
studies was 16.4 months, this endpoint has not yet been reached in
the second study, which is ongoing, although enrollment has been
completed.

For more information, please visit www.pfizer.com .

Web site: http://www.pfizer.com

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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