NIH Press Release
NATIONAL INSTITUTES OF HEALTH
National Cancer Institute

FOR IMMEDIATE RELEASE
Tuesday, October 6, 1998

NCI Press Office
(301) 496-6641


With Herceptin® Now Available, Registration Ends for NCI's Expanded Access Program

The Food and Drug Administration approved Herceptin® for marketing on Sept. 25, and the drug became commercially available on Oct. 5, according to Genentech, Inc., the company in South San Francisco that makes the drug. Accordingly, registration of new patients on the National Cancer Institute's (NCI's) expanded access trials with Herceptin ends on Oct. 7 at 4:30 p.m.

Patients already registered may continue to be treated and monitored on protocol until January 7, 1999. Patients not registered on the trials will be able to receive the drug through normal medical/pharmaceutical channels. Genentech has stated it is committed to ensuring that there will be no interruption in patients' access to Herceptin.

Assistance with patient reimbursement needs is available from Genentech's Single Point of Contact (SPOC) reimbursement service for health care professionals and consumers (1-888-249-4918). SPOC also manages the company's Patient Assistance Program which provides access for uninsured patients.

The expanded access program has made Herceptin available to patients with metastatic breast cancer who did not meet the criteria for other research studies. Until recently, eligible patients had to enter a lottery in order to participate in this program. The lottery was instituted by Genentech to fairly distribute the very limited supplies of the drug.

Initially, patients selected by the lottery received the drug as part of a Genentech study at about 10 different hospitals. Several changes have been made in this system recently:

In addition to the reimbursement hotline given above, Genentech has two other information lines: Genentech Medical Information (1-800-448-3405) provides medical and full prescribing information to health care professionals and consumers. In addition, Genentech Customer Service (1-800-551-2231) provides ordering and shipping information.

More information on NCI's expanded access protocols is available from the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237)

For more information about cancer, visit NCI's Web site for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main web site at http://www.nci.nih.gov.