Herceptin's FDA Approval Means Drug Will Soon Be Available, Registration Will End for NCI's Expanded Access Program

National Cancer Institute
Tuesday, 29 September 1998

The Food and Drug Administration approved Herceptin® (Trastuzumab) for marketing on Sept. 25, and the drug will be commercially available within two weeks of that date, according to Genentech, Inc., the company in South San Francisco that makes the drug. Registration of new patients on the National Cancer Institute's (NCI's) expanded access trials with Herceptin will end on the day the drug is launched commercially.

Patients already registered by that date may continue to be treated and monitored on protocol for three months after the drug becomes available commercially. Patients not registered on the trials by that date 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.

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:

- Last spring, NCI and Genentech arranged to make the drug available in more locations. Through its Treatment Referral Center, NCI opened a new expanded access protocol, known as TRC-9801. Eligible patients, selected through the lottery, could enroll in this study at any NCI-designated cancer center that had approved the TRC-9801 protocol.

- The lottery ended on Sept. 18. With supplies of the drug increasing, TRC-9801 was opened to any eligible patient who had been entered on the lottery but not selected, as well as other eligible patients.

- At the same time, NCI initiated a second protocol, called TP-98-01, for those who had been entered on the lottery but not selected. TP-98-01 allows patients to participate in the expanded access protocol with their local oncologists rather than by traveling to a participating cancer center.

For more information on Herceptin's commercial availability, patients and physicians may call Genentech's toll-free Herceptin information line, 1-888-777-4464.

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

For more information, or to contact National Cancer Institute, see their website at: www.cancer.gov