Pfizer's Sutent Is Granted Full Marketing Authorization for First-Line Use in Advanced Kidney Cancer in the European Union
- Full marketing authorization and extension of indication to
first-line treatment of advanced and/or metastatic renal cell
- First multiple receptor tyrosine kinase inhibitor to be
approved in the EU for first-line use in MRCC
NEW YORK, January 18/PRNewswire/ -- 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.
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
"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
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
Source: Pfizer Inc
Oliver Stohlmann, +43-66-4335-0485 or +43-15-211-5337, or
Vanessa Aristide, +1-212-733-3784, both for Pfizer Inc. Company
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Posted: January 2007