ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, March 30, 1996 TAG: 9604010018
SECTION: NATIONAL/INTERNATIONAL PAGE: A3 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: ASSOCIATED PRESS
Cancer patients will get quicker access to promising new drugs, much as AIDS patients already do, under a program announced Friday by President Clinton.
The Food and Drug Administration program could shave one to three years off the time some 100 cancer drugs now in development will be tested.
It also could cut in half the 12 months the FDA typically spends deciding a cancer drug is ready for sale - and allow dying Americans special access to cancer therapies approved in Australia, Canada or Europe but not yet on the market here.
``The waiting is over,'' said Clinton, who lost his mother and stepfather to cancer. ``We cannot guarantee miracles, but at least now new hope is on the way.''
About 1.3 million Americans get cancer annually, and one in three people will develop it over a lifetime. Caught early, many cancers are treatable - some 7 million Americans are considered cured. Still, 1,500 cancer victims die every day.
Since 1991, the FDA has offered special ``accelerated approval'' to drugs promising hope for any life-threatening disease. Instead of proving a drug prolonged life in hundreds of patients, medicines could be sold when small studies showed they helped a vital symptom.
Eleven drugs have won fast approval under the program, including seven for AIDS - one of which was approved in a record 42 days - and a breakthrough for multiple sclerosis.
Only one cancer drug is in the group, Zeneca Pharmaceuticals' Casodex for advanced prostate cancer.
The FDA on Friday provided guidelines for makers of cancer drugs: Simply show in Phase II trials that the medicine makes a tumor shrink. Expensive, final testing in many more patients will still prove the drug's long-term effectiveness, but those Phase III studies can run while the drug is being sold.
LENGTH: Short : 46 linesby CNB