Here's what AP had to say after the close:
FDA Panel OKs Cancer Immunotoxin
Tuesday, June 2, 1998; 6:04 p.m. EDT
WASHINGTON (AP) -- A bioengineered toxin should be approved to
treat a certain type of advanced lymphoma, government advisers
unanimously recommended to the Food and Drug Administration
Tuesday.
If the FDA ultimately agrees, Seragen Inc.'s Ontak could become the
nation's first immunotoxin, a unique type of cancer fighter.
At issue is cutaneous T-cell lymphoma, a rare lymph cancer that attacks
the skin, starting with severely itchy lesions.
Ontak consists of an immune system protein called interleukin-2 and a
noninfectious portion of diphtheria toxin. The IL-2 binds to receptors on
lymphoma cells, allowing the toxin to slip inside and kill the cells, explained
Dr. Patricia Keegan of the FDA's Center for Biologics.
Seragen's major study infused Ontak into 71 advanced patients who had
failed standard treatments, Keegan said. Thirty percent of tumors
significantly shrank; seven disappeared.
The study couldn't tell how the tumor shrinkage affected patients' overall
symptoms, or how long the effect lasted, Keegan said. Seragen has begun
a larger trial to get those answers.
But the FDA's advisors said the early study was enough for Ontak to be
approved under a special program that allows promising cancer drugs to
be sold before final research is done.
The FDA is not bound by its advisers' recommendations, but typically
follows them.
Ontak caused numerous side effects, including fever and flulike symptoms
in 90 percent of patients, Keegan cautioned. Most of the side effects
responded to brief treatment. But the panel decided the side effects mean
Ontak should be offered just to advanced patients who have failed other
options, she said.
|
