FDA Advisory Committee Panel Recommends Approval of ZEVALIN
for Treatment of Certain Non-Hodgkin's Lymphomas
SAN DIEGO--(BW HealthWire)--Sept. 11, 2001--IDEC Pharmaceuticals Corporation (NASDAQ: IDPH - news)
announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration
(FDA) recommended approval of ZEVALIN(TM) (Ibritumomab Tiuxetan), an investigational agent, for the proposed
treatment of rituximab-refractory follicular, B-cell non-Hodgkin's lymphoma (NHL).
With respect to the use of ZEVALIN for treatment of patients that are not rituximab-refractory, that is, patients with
relapsed or refractory, low grade, follicular or CD20-positive transformed, B-cell NHL, the Committee recommended
that the FDA consider approval of ZEVALIN in this indication under the agency's accelerated approval regulations.
While the ZEVALIN BLA was not filed under the accelerated approval regulations, given the Committee's
recommendations, the Company will discuss with the FDA the merits of an accelerated approval approach for
ZEVALIN and its implications on product labeling and the timing of BLA approval.
The Advisory Committee consists of individuals recognized as experts in various fields including medicine, science and
research, industry, and consumer/patient advocacy. While the Committee's recommendations are a milestone, the FDA
will determine the applicability of the accelerated approval regulations and will make the final decision whether or not
to approve ZEVALIN. IDEC will continue to work with the FDA to implement the Advisory Committee's
recommendations.
``We are delighted the Advisory Committee recommended approval of a first-in-class radioimmunotherapy,'' said
William H. Rastetter, Ph.D., Chairman, Chief Executive Officer and President of IDEC. ``ZEVALIN represents years
of tireless work on the part of hundreds of IDEC employees. If approved by the FDA, we believe ZEVALIN will
provide a potential treatment alternative for certain non-Hodgkin's lymphoma patients.''
Christine A. White, M.D., IDEC's Vice President of Medical Affairs, gave the Company's scientific and medical
presentation of ZEVALIN data to the ODAC panel. More than 500 NHL patients have been treated with ZEVALIN
in clinical trials sponsored by IDEC throughout the U.S.<snip> |
