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

National Cancer Institute
Tuesday, 6 October 1998

The Food and Drug Administration approved Herceptin® (Trastuzumab) 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 at 4:30 p.m., on Wednesday, Oct. 7.

Patients already registered may continue to be treated and monitored on protocol until Jan. 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:

- 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 entered the lottery but was not selected, as well as other eligible patients.

- At the same time, NCI initiated a second protocol, called TP-98-01, for those who entered the lottery but were 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.

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.

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