WASHINGTON _ The FDA expects as many as 100 applicationsfor promising new anti-cancer therapies will be presented to theagency as the result of last week's White House announcement tospeed up the review of these therapies.

Several biotech companies currently developing anti-cancer drugshave assumed a wait-and-see attitude about whether the FDA reallywill improve the review of anti-cancer drugs. "President Clinton andFDA Commissioner David Kessler have stuck their necks out. Bypromising that new anti-cancer therapies will be reviewed within sixmonths, they will be held accountable by patient groups, physiciansand drug companies," said Bill Rastetter, president of IDECPharmaceuticals Corp., of San Diego.

Currently the FDA reviews most cancer drugs within 12 months ofsubmission.

ImmunoGen Inc., of Cambridge, Mass., still is trying sort out how thepolicy change will affect its product. According to ImmunoGenchairman and CEO Mitchel Sayare, "Our reviewer in the Center forBiologics Evaluation and Research [CBER] has said they are not sureif the policy change applies to them. Until the agency has clarifiedthese changes internally, it's difficult for us to make a decision aboutwhether our studies meet the agency's new criteria.

"We have a solid response rate from Oncolysin B for B celllymphoma. It could be evaluated by the FDA right now based onpromising Phase I and Phase II results but we need to work that outwith the FDA," Sayare said.

Mike Friedman, FDA deputy commissioner for operations, in aninterview with BioWorld Today, said the agency estimates at least250 anti-cancer therapies could be reviewed under the acceleratedapproval process announced by the White House last week. "Aconservative estimate says that about half of these could becandidates for the accelerated mechanism," Friedman said. "If weultimately get a dozen products on the market, it would be a greatbenefit to patients."

Friedman said he is committed to meeting the six-month deadlinebecause of the resources made available by user fees paid by drugmanufacturers. "User fees permit us to have the reviewer availablewhen an application crosses the threshold at the FDA." If the six-month deadline sound familiar, it is one of the principle provisions ofSen. Nancy Kassebaum's (R-Kan.) FDA reform bill that cleared hercommittee less than 24 hours before the White House announcement.

Friedman said the agency was flexible about the size of the clinicaltrial and the product's comparability with existing oncologytreatments. "A single trial might be acceptable if the data were notambivalent. It depends on the situation and the magnitude of thebenefit. There are some cancers such as pancreatic and brain cancerwhere a small benefit would be important. But in other cancers suchas lymphoma and breast cancer, where existing therapies have adramatic therapeutic effect, a competing therapy would have to showvery good results," Friedman said.

"If a drug manufacturer has completed a modest-size Phase II clinicaltrail that has clean clinical endpoints and has produced good data, itclearly would be eligible for accelerated approval," he said. "Acouple of Phase II trials with a small number of patients would beeasier and faster for a manufacturer to complete than a large Phase IIItrial with hundreds of patients."

Drug companies that already have a cancer therapy approved abroadwould be eligible for an expanded access program in the U.S. whileits drug is under review at the FDA, Friedman said.

While the policy changes were effective March 29, 1996, furtherdetails on the newly announced FDA policy will be discussed at theApril 19, 1996, meeting of the Oncology Drugs Advisory Committee.To be included on that agenda will be other FDA proposals such asexpanding membership of FDA advisory committees reviewingcancer drugs to include more patient representatives.

The FDA also has proposed to drastically reduce the number ofsupplemental applications for additional indications for oncologytherapies a manufacturer would have to file. The agency said that inmany circumstances these supplemental applications are unnecessaryand will eliminate the requirement that they be filed "to allowinvestigators to devote more of their time to the challenges of cancerresearch." n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.