FDA Restricts Cancer Therapy

To Small Group of Patients

The government will allow only a few thousand lung cancer patients to continue using a last-chance therapy after the highly touted Iressa failed to live up to its promise for most users.

The Food and Drug Administration's decision yesterday means that patients with advanced lung cancer who believe the drug is helping them won't lose access to it -- but that after Sept. 15, any new patients who wish to try Iressa will have to do so in a strictly controlled research study.

About 4,000 Americans are taking Iressa. Fear that they would lose it had been building since March, when the drug failed to live up to expectations in a key study.

Beginning Sept. 15, Iressa will be sold only through one mail-order pharmacy, which will require special documentation of eligibility by the doctor and patient, maker AstraZeneca announced.

It's the first time the FDA has taken such action for a cancer treatment approved under its special program that lets promising therapies sell before research proves whether they increase survival.

Iressa was one of the first targeted cancer therapies when it hit the market in 2003 for advanced lung cancer, but only about 10 percent of patients had any response to Iressa.

Test Wins Approval for Use

In Predicting Stroke Risk

A blood test already used to help screen for heart problems won U.S. approval to help predict a patient's risk for stroke, officials for the firm that makes it said yesterday.

The PLAC test, made by privately held DiaDexus, scans for high levels of the protein lipoprotein-associated phospholipase A2 (Lp-Pla2), which are more common in stroke patients.

The study followed a patient sample culled from a pool of 12,773 for about six years. During that time, 194 people suffered an ischemic stroke, while 812 did not.

Researchers found levels of the protein were higher in the resulting stroke cases.

The National Institutes of Health and GlaxoSmithKline funded the study.

Antipsychotic Drug Linked

To Pituitary Gland Tumors

Patients taking Johnson & Johnson's Risperdal antipsychotic drug developed tumors in the pituitary gland at a higher rate than people on similar drugs, a review of adverse events reported to U.S. regulators showed.

More than two-thirds of the 64 benign pituitary gland tumors reported to the U.S. Food and Drug Administration for people on antipsychotic medications were in patients taking Risperdal, according to an analysis led by Ana Szarfman, an FDA medical officer. The findings were presented at a scientific meeting on bipolar disorder yesterday in Pittsburgh.

U.S. regulators in recent weeks rejected applications to market Risperdal, Johnson & Johnson's second best-selling drug, to treat autism and psychosis in patients with Alzheimer's disease.

Risperdal was one of seven antipsychotic drugs that the FDA said in April should have prominent label warnings citing the drugs' link to an increased risk of death when used to treat behavioral disorders in elderly patients with dementia, a use for which none of them has FDA approval.

"It's very preliminary data that FDA will have to review and research further" before basing any action on it, agency spokeswoman Susan Cruzan said in a telephone interview.

-- From News Services