The National Cancer Institute (NCI) has announced that Genentech has increased the supply of Herceptin® enough to end the lottery for access to the drug through an NCI study. The lottery was put in place by the drug company, which is based in South San Francisco, to fairly dispense the very limited amount of the experimental drug to patients who did not meet the criteria for other research studies. All patients previously entered into the lottery but not selected can now be treated with Herceptin.

The lottery was used to select which of the patients eligible for the NCI study could be treated with this monoclonal antibody. The lottery was closed at the end of the day Friday, Sept. 18.

The Food and Drug Administration (FDA) is expected to decide soon whether to approve the drug for marketing. In a unanimous vote Sept. 2, its Oncologic Drug Advisory Committee recommended that the agency approve Herceptin. FDA's approval would allow Genentech, the drug's manufacturer, to make the drug available commercially.

Until that happens, NCI - working with Genentech and the FDA - is increasing patient access to this drug by expanding its studies with Herceptin. Although priority will be given to patients already enrolled in the lottery, others will now have increased access to Herceptin.

Breast cancer patients who meet the original lottery criteria can get Herceptin in the following ways:

• All patients who entered the lottery before 4:30 p.m., Sept. 18, but were not selected, will now be able to receive the drug through either of two mechanisms. They can register to participate in the current clinical trial (called the TRC-9801 protocol) at a participating NCI-sponsored cancer center. Or they can register in a new treatment protocol (TP-9801) that will allow the patient's primary oncologist to enroll the patient, administer the drug, and follow up on that patient's care.
• Eligible patients who have not entered the lottery may receive Herceptin through a participating cancer center on protocol TRC-9801, if waiting for commercial release is not a reasonable option.

NCI has asked the cancer centers who participate in the ongoing treatment protocol (TRC-9801) to contact the local oncologists of patients entered in the lottery but not selected. The centers have been asked to notify those doctors about the availability of Herceptin for their patients. These patients are eligible to participate in either TRC-9801 or the new treatment protocol (TP-9801). They also have the option of awaiting commercial availability, which should occur soon.

To enter either protocol, all patients must have disease that has recurred or progressed following treatment with two regimens for advanced breast cancer that expresses the HER2 protein. There are also certain other eligibility requirements. To obtain information regarding eligibility and cancer center locations, patients can call NCI's Cancer Information Service (CIS) at 1-800-4-CANCER.

While a percentage of other types of cancer express HER2, there is no experience to suggest that Herceptin can treat them. Clinical trials to determine whether Herceptin will help in these diseases are being planned.

The FDA has made action on Herceptin a high priority. Once the drug has FDA approval, patients will be able to obtain the drug through normal pharmaceutical channels.

See also: Questions and Answers About NCI's Expanded Research With Herceptin®