Q&As on Iressa's (gefitinib) New Labeling (cont.)

10. What about patients who are already taking Iressa?

Patients who are currently receiving and benefiting from Iressa, or who have taken and benefited from Iressa in the past, may continue to receive the drug. The Iressa Access Program will allow those patients continued access to Iressa. Previously enrolled patients or new patients in non-IND clinical trials approved by an IRB (Institutional Review Board) prior to June 17, 2005 are also eligible to receive Iressa under the Iressa Access Program. Patients enrolled or who may in the future enroll in a clinical trial conducted under an IND may also continue to receive Iressa.

11. Is this decision based on safety concerns?

The main concern is that Iressa would be used in new patients in lieu of other approved treatments that have been shown to improve patient survival. Since the approval of Iressa, Tarceva (erlotinib), an oral drug similar to Iressa, has been approved for treatment of patients with advanced NSCLC who have had prior chemotherapy. Tarceva has been shown in clinical trials to significantly improve patient survival. Taxotere, a chemotherapy drug, has also been shown in clinical trials to improve survival in this group of patients.

12. Has there been a limited access program for an anticancer drug before?


13. Have other anticancer drugs received accelerated approval and subsequently been withdrawn from the market or made available in a limited access program? If so, what are they?


14. Will Iressa eventually be pulled completely from the market?

The FDA is not currently considering withdrawal of Iressa. When the number of patients receiving Iressa under the limited access program becomes small, Iressa may either be removed from the market or, depending on any additional clinical data, the indication may be modified. There are ongoing clinical trials and other clinical trials are planned that may support approval of Iressa for a new indication. If Iressa is eventually withdrawn from the market, the FDA will consider authorizing continued Iressa access under an IND protocol for patients who are benefiting or have benefited from Iressa.

15. What are other treatment options for NSCLC?

Tarceva and Taxotere have been shown to prolong survival in patients with advanced NSCLC who have had prior chemotherapy. Alimta has also been granted accelerated approval for treatment of these patients.

16. What impact does Tarceva have?

Tarceva prolonged life by an average of 2 months in patients with advanced NSCLC who had received one or two prior chemotherapy regimens.

17. How are Tarceva and Iressa similar?

Tarceva and Iressa are similar drugs. Both are targeted therapies. Both are EGFR tyrosine kinase inhibitors.

Source: FDA, Center for Drug Evaluation and Research, June 17, 2005

For additional information, please read the "New Labeling for Iressa (gefitinib)" article.

Last Editorial Review: 6/21/2005