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Rituxan Receives FDA Approval for 2 New NHL Indications

Rituxan Receives FDA Approval for 2 New NHL Indications

ROCKVILLE, Maryland--Rituxan
(rituximab, Genentech/Biogen Idec) has
been approved for two new indications
in patients with CD20-positive, B-cell
non-Hodgkin's lymphoma. After an accelerated
review, FDA approved Rituxan
for the first-line treatment of previouslyuntreated
patients with follicular NHL
in combination with cyclophosphamide,
vincristine, and prednisone (CVP) and
for use in low-grade NHL patients with
stable disease or who have achieved a
partial or complete response following
first-line treatment with CVP.

"These approvals are the result of an
extraordinary collaboration between
Biogen Idec, Genentech, the Eastern
Cooperative Oncology Group, clinical investigators,
the FDA, and most importantly,
the patients who participated in
the clinical trials," said Hal Barron, MD,
Genentech's senior vice president for development
and chief medical officer.

An estimated 360,000 Americans are
currently living with NHL, and physicians
diagnose more than 58,000 new
cases each year. Approximately 85% of
NHL cases involve B-cells, and 30%
of NHL patients have slow-growing but
incurable (low-grade) disease.

Rituxan is a genetically engineered
murine/human monoclonal antibody,
which binds specifically to the CD20 antigen
found on normal and malignant B
lymphocytes. This binding results in cell
lysis. The drug initially received FDA
approval in 1997 as a single agent for
patients with relapsed or refractory,
low-grade or follicular CD20-positive,
B-cell NHL. Earlier this year, the agency
approved Rituxan, in combination with
CHOP or other anthracycline-based
chemotherapies, as a first-line treatment
for patients with diffuse large B-cell lymphoma
(DLBCL).

Delay Disease Progression
"The goal of treating low-grade or follicular
NHL . . . is to delay disease progression
for as long as possible," said
Howard Hochster, MD, professor of
medicine and clinical pharmacology, New
York University's School of Medicine and
Cancer Institute. "These approvals enable
doctors and patients to select among
different treatment options with Rituxan
in the front-line setting. As we demonstrated
in the Eastern Cooperative
Oncology Group [ECOG] trial, the use
of extended Rituxan dosing following
induction of CVP chemotherapy in patients
who reached stable disease or better
has been shown to decrease the risk of
disease progression, relapse, or death."

FDA approved the first-line use of the
drug in previously untreated follicular,
CD20-positive, B-cell NHL patients based
on findings of a phase III controlled,
multicenter open-label study of 322 patients
randomized to receive up to eight
3-week cycles of CVP alone or in combination
with Rituxan 375 mg/m2 on the
first day of each cycle.

An independent review found a significantly
increased progression-free survival
for the Rituxan/CVP patients, 2.4
years vs 1.4 years for those receiving CVP
alone. Rituxan/CVP reduced the risk of
disease progression, relapse, or death
by 56%, compared with CVP alone
(P < .0001).

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