[hutchibk]

GD - "Tykerb taken with food potentially cuts drug costs"...

This is not a new controversy or idea... My doctor and I talked about it last summer (and he was not yet interested in something so speculative without any scientific studies behind it) and then I talked to doctors at SABCS who were heavily involved in phase 1 to phase 3 trials of Tykerb (Dr. Burris and Dr. Hayes) as well as one of the scientists who was on the team that "invented" it... and they all strongly agreed with this response from GSK.
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GSK’s Response to JCO commentary – July 17, 2007
In response to commentary published by Ratain and Cohen in the July 20,2007 issue of the JCO, GlaxoSmithKline issues the following statement:

Speculative statements by Ratain and Cohen in a recent JCO commentary have the potential to be misunderstood and misused by clinicians and patients. TYKERB® (lapatinib) is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Breast cancer is a serious and potentially life threatening disease. In order for treatments like TYKERB to be used safely and effectively, it is critical that TYKERB is prescribed and taken correctly, as approved by the FDA. The effectiveness of TYKERB depends on the right amount of medicine reaching the cancer cells. TYKERB should be taken at least one hour before or at least one hour after food. The current FDA-approved labeling for TYKERB was established based on the efficacy and safety data from the pivotal Phase III study, in combination with capecitabine. Currently there is no evidence to support that adjusting the dose of TYKERB, in combination with either food or grapefruit juice may be as safe or effective for the patient. While dosing TYKERB with food has been found to increase absorption, food effects are highly variable and hard to predict. Taking TYKERB with food could result in increased side effects and decreased efficacy. Additionally, concurrent medicines that patients may be taking, including capecitabine, must be considered. Each medicine has its own potential for drug and food interactions. Therefore, it is imperative that patients follow the current FDA approved TYKERB dosing and administration recommendations without food so that a consistent amount of the medicine is absorbed by the body. Finally, our clinical experience indicates that dosing with food does not impact the incidence of diarrhea associated with TYKERB. The speculation that this side effect is due to unabsorbed drug in the intestine, and that dosing with food would decrease this toxicity, is not validated by our clinical experience. Identifying cost-savings for the healthcare system and cancer patients is necessary. However, making speculative dosage adjustments for this potential “value meal” does a disservice to patients with this life threatening disease and the healthcare professionals who treat them.