[gdpawel]

Tykerb is one of the first oral agents with the potential to compete directly with the IV drugs which is both a high-volume and high-revenue part of office-based practices. Early use of Tykerb will likely be limited to patients whose breast cancer is refractory to Herceptin. In the longer term, it could supplant or perhaps find a place in combination with Herceptin.

Although oral tyrosine kinase inhibitors, like Tykerb, offer patients a well-tolerated, conveniently administered alternative to intravenous (IV) therapy, Decisions Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, found that oncologists are not yet ready to use Tykerb as a replacement for Herceptin. Ninety-one percent of surveyed oncologists stated that intravenous (IV) cancer therapies are more profitable than oral therapies. And fifty-eight percent of oncologists say they would favor IV Herceptin over oral Tykerb because administration of IV drugs remains an important source of income for their practices.

Of course, will patients be able to afford the cost of these drugs? Herceptin's wholesale price on an annualized basis is approximately $45,000 per year. Tarceva, $40,000 per year. Nexavar, $60,000 per year. Avastin, $47,000 per year. Will the price of Tykerb approximate these novel agents or exceed their costs? The problem is not unique to these drugs, but also to all of the new molecularly-targeted agents.

Lee Newcomer, former chief medical officer and currently an executive with United Health Group, stated at the 12th annual conference of the National Comprehensive Cancer Network, that "Avastin improves outcomes in about 20% of patients, but we have no idea which cancer patients will benefit from a course of treatment. Because Avastin is included with numerous drug cocktails, it costs $354,000 per year of life extended with Avastin because of today's 'cookie-cutter' approach to chemotherapy. You don't know in advance who is going to respond."

Everyone is scared to death (and rightly so) at what is going to happen to the healthcare economic system with the introduction of increasingly expensive new drugs that benefit only a small percentage of patients who receive them, hence the headlong rush to develop tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.

The FDA finds themselves under increasing pressure to allow new drugs into the marketplace, while at the same time protecting the safety of potential recipients of those drugs and also the financial interests of those who will have to pay for them. The pressure is so great that companion molecular diagnostics approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.

It should be in the FDA's interest in saving the healthcare system perhaps billions of dollars a year (and thereby the healthcare system itself) by ensuring that expensive treatments are used appropriately. It should serve their interest not only in discovering new cancer treatments, but also using currently-available cell culture assay technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.

The methods of cancer medicine during the last thirty some years are coming to haunt the "one-size-fits-all" establishment. Technologies, developed over the last twenty years by private researchers, hold the key to solving some of the problems confronting a healthcare system that is seeking ways to best allocate available resources while accomplishing the critical task of matching individual patients with the treatments most likely to benefit them.