Does GSK offer an Expanded Access Program for lapatinib?
On June 3, 2006, GSK announced the opening of a Lapatinib Expanded Access Program (LEAP). This program provides treatment with lapatinib in combination with capecitabine for the treatment of advanced and metastatic breast cancer. Although lapatinib is not yet approved for marketing by most regulatory authorities outside of the US, GSK recognizes that at this stage in the development program physicians may wish to consider treating certain patients with lapatinib based on clinical evidence to date. Therefore, after discussion and agreement with Regulatory Authorities, GSK is currently enrolling sites and patients for a global Expanded Access Program (EAP). The EAP program is or will be opened worldwide, as regulatory approvals needed to start the EAP program in those regions are obtained. The EAP will provide access to lapatinib for the group of seriously ill patients that have been shown to benefit in our clinical trials.
