Promising lymphoma treatment clears a hurdle
Monoclonal antibody still needs FDA approval
July 28, 1997
Web posted at: 10:59 p.m. EDT (0259 GMT)
From Correspondent Jeff Levine
WASHINGTON (CNN) -- A promising new treatment for
non-Hodgkins lymphoma cleared a hurdle Friday
and is nearing government approval.
It's called a monoclonal antibody, a chemical agent that
seeks out and destroys cancer cells the way a guided missile
seeks out and destroys its target.
Among those attesting to its efficacy in treating the
immune-system cancer was a doctor who sent her
endorsement in a letter to a U.S. Food and Drug
Administration advisory panel meeting in Washington.
"As far as she is concerned, it's sort of a miracle of modern
science," says Kathryn Adams of the Cure for Lymphoma
Foundation. "She feels this drug is her only hope and is a
great hope, as she said in her statement, for a long and
happy life."
The panel also heard about a study of 160 patients with
non-Hodgkins lymphoma for whom other treatments
had failed.
About half of them got better using a monoclonal antibody
called IDEC C2B8, and they stayed healthy for at least nine
months.
The letter, the study and other testimony convinced the panel
to recommend unanimously that the FDA approve the therapy.
Easier on patients than chemotherapy
"I felt that the risks are certainly acceptable, and I think
it does represent a drug that we can use," said Dr. Carole
Miller of the Johns Hopkins Oncology Center and a member of
the panel.
The new treatment is easier on patients than chemotherapy or
radiation, and its main side effects are flu-like symptoms.
"This antibody is not just active, but it's safe," says Dr.
Antonio Grillo-Lopez of IDEC Pharmaceuticals, the company
that makes IDEC C2B8. "It is effective, and it provides
significant benefits to the patient."
Monoclonal antibodies were heralded as a magic bullet 20
years ago, but they have proved difficult to target at tumor
cells only.
If approved, IDEC C2B8 could be the beginning of a new
generation of cancer treatments that are tough on tumors and
kinder to the patient.
Although the FDA must still make the final decision to
approve it, backers of the treatment feel it could be
approved and available by the end of the year.
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