GSK Approves Tykerb - Compassionate Use

[Joe]

We have been negotiating with GSK to release Tykerb for compassionate use. It looks like we had great results.

Christine and Joe



TYKERBÒ (Lapatinib)


FREQUENTLY ASKED QUESTIONS

What is an Expanded Access Program (EAP)?

An Expanded Access Program is a defined protocol based on specific safety and efficacy data from a Phase III clinical development program for a specific disease. EAPs are offered before a drug is approved by the U.S. Food and Drug Administration (FDA) and the drug becomes commercially available.



Does GSK offer an Expanded Access Program for Tykerb?

On June 3rd, GSK announced the opening of an Expanded Access Program (EAP) for Tykerb, in combination with capecitabine for the treatment of advanced and metastatic breast cancer. Although Tykerb is not yet approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory body, GSK recognizes that at this stage in the development program physicians may wish to consider treating certain patients with Tykerb based on clinical evidence to date. GSK is currently enrolling sites for a Global Expanded Access Program (EAP). The EAP program will open Globally over the next several months, as regulatory approvals needed to start the EAP program in those regions are obtained. The EAP will provide access to Tykerb for the group of seriously ill patients that have been shown to benefit in our clinical trials.



What are the entry criteria for the Tykerb EAP?

If a patient is not eligible for another Tykerb clinical trial and has advanced or metastatic ErbB2 overexpressing breast cancer, she may be eligible for the EAP. In particular, those patients who have previously received therapies containing anthracycline, taxane and trastuzumab and have progressive disease may be eligible. Patients will work with their medical oncologists to determine eligibility. For more information regarding qualification and enrollment in the U.S. and additional details on the Tykerb EAP, please call: 1-888-4TYKERB (489-5372). In Europe and Internationally inquiries from physicians can be directed to the following website: breastcancereap@gsk.com. Outside of the U.S. patients should consult their physicians.



How can I enroll in the Tykerb EAP?

Begin by talking to your oncologist about eligibility for the Tykerb EAP. The call center number for information about the Tykerb EAP in the U.S. is 1-888-4TYKERB (489-5372). Patients should press (1) and will be transferred to a call center representative at the National Organization for Rare Disorders (NORD).



Additional information on Tykerb studies is available at www.clinicaltrials.gov.



In Europe and Internationally inquiries from physicians can be directed to the following website: breastcancereap@gsk.com. Outside of the U.S. patients should consult their physicians.



Will the Tykerb EAP be limited to breast cancer treatment?

At this time the EAP will be limited to patients with advanced or metastatic breast cancer.



How many patients can enroll in the Tykerb EAP and how long is the program expected to last?

There is no set limit on enrollment for patients who meet eligibility requirements. The Tykerb EAP is expected to continue until Tykerb is approved by regulatory authorities. Local guidelines will apply to the Tykerb EAP in countries outside the U.S.



Where will the Tykerb EAP be available?

In the U.S. existing Tykerb clinical trial sites are eligible to participate in the EAP program. Additionally, Medical Oncologists who are not participating in Tykerb clinical trials have an opportunity to become a participating site by contacting 1-877-4TYKERB. In Europe and International regions, physicians should contact GSK country staff. The Tykerb EAP will be available in most countries where GSK expects to file for regulatory approval.



What if I can’t get to a distribution site?

GSK is committed to optimizing the geographic distribution of participating sites to minimize the likelihood that this will occur. Throughout the course of the program GSK will be working with investigators, institutions, and regulatory agencies to address urgent patient need with the EAP.

Patients should begin by talking to their oncologist about Tykerb EAP sites in their area. If they can not receive Tykerb through their oncologists, they will be directed to the closest participating site.



How much will the product cost through the EAP?

Patients will not pay for Tykerb while enrolled in the EAP in the U.S.



Local guidelines will apply to the Tykerb EAP in countries outside the U.S.