I've just received some sad and shocking news: The cancer drug that saved my life 14 years ago and has saved the lives of so many other cancer patients is about to be discontinued. A spokesperson for GlaxoSmithKline (GSK), the international pharmaceutical company, sent me a note today informing me that the the company will halt the manufacture and sale of Bexxar on Feb. 20, 2014.
Bexxar is a so-called radio-immunotherapy (RIT) that is currently approved for the treatment of certain types of non-Hodgkin’s lymphoma, including the most common type, follicular. I was treated with Bexxar in a clinical trial in April, 1999 and have not been treated for my cancer since - though I did fall out of remission recently and am currently mulling over my treatment options.
Simply put, Bexxar saved my life, and has saved the lives of many of my fellow cancer patients, some of whom are profiled in my book "Hope Begins in the Dark: 40 Lymphoma Survivors Share Their Exclusive Life Stories."
The company says it was announcing its decision now "to give treatment centers in the U.S. and Canada currently offering Bexxar adequate time to consider and, if appropriate, transition to other therapies."
The note also suggests that the decision to discontinue Bexxar "involved a thoughtful and careful evaluation of patient needs and the clinical use of the therapy. The use of Bexxar has been extremely limited and is projected to continue to decline. Additionally, there are other treatment options available for patients with relapsed non-Hodgkin’s lymphoma."
But studies have shown that RIT – both Bexxar and its competitor, Zevalin - have given non-Hodgkin's lymphoma patients longer remissions than any other available treatment, including the so-called standard of care: chemotherapy plus Rituxan. Yes, Bexxar is evidently more effective and less toxic than the treatment that is still being used in far greater numbers.
|Dr. Mark Kaminski, developer of Bexxar|
Bexxar, which was developed by Mark Kaminski, a kind and brilliant hematologist and researcher at the University of Michigan, was never really given a chance to succeed for a variety of reasons that have nothing to do with how effective it is.
Bernadette King, a GSK spokesperson, told me today that GSK considered a "range of options" in an attempt to continue to make Bexxar available for patients. But after a "substantial and considered review, the company reached the decision to discontinue the manufacture and sale of the product," she says.
"However, in keeping with GSK’s focus on transparency and collaboration, GSK plans to make available, for legitimate research purposes, the cell line that secretes the anti-CD20 antibody used to make Bexxar," King adds. "Access to the cell line will require that the user first enter a material transfer and other appropriate agreements. Because GSK will provide such access to the cell line, GSK does not plan to replenish antibody supply."
King concluded, "As you know, Bexxar is a therapy that involves very complicated manufacturing and supply chain processes. The cell line is but one component of the product. It is used to produce the antibody for that product. It would be the responsibility of the user to assess the utility of the cell line in the manufacture of a biosimilar in any country, or for research or other purposes, and to obtain any licenses required for any contemplated use, e.g.intellectual property or regulatory licenses."
There are years and years of research dedicated to Bexxar, a highly effective therapy that offers an easy and quick treatment time of about one week. It's very well tolerated and for most people causes few side effects. I had virtually none, other than some tiredness and temporarily low blood counts.
Bexxar often results in very long remissions. I know several people who have been treated with Bexxar who are still in remission more than a decade later. It gave me an almost miraculous 13-plus years of remission. Whereas the chemotherapy I did in 1997 gave me less than two years. Pretty simple math, yes?
But since its approval 13 years ago, it seems no one has known how to market this treatment. RIT has been used by fewer than ten percent of patients who might benefit from it. It's a tragedy, the slow but sure demise of this drug. It clearly has more to do with money, and doctors’ refusal to embrace something new, and drug companies’ refusal to fight for this drug, than with saving lives.
Thankfully, Zevalin, which is manufactured by Spectrum Pharmaceuticals, is still available. But one must wonder now about Zevalin's future, too.
Over the next six months, GSK says it will continue to provide support services for patients and treatment centers. Physicians and patients with questions can call the GSK Response Center (GRC) at 888-825-5249.
At the bottom of its announcement today, GSK ended with the most offensive line: "GSK’s commitment to the oncology community will continue through our efforts to develop and deliver other therapies to help address the unmet needs of patients living with cancer."
In my opinion, this company never did enough to support or promote Bexxar. I tried on an almost daily basis over the past decade to spread the word about this amazing treatment. The drug company simply gave up on it. I know it was difficult dealing with oncologists' resistance. But the company still should have tried harder and spent more money to market this drug and let people know just how effective it really is.
Over the last decade, RIT has been the subject of considerable media attention. Publications ranging from my longtime employer, Newsweek, to the New York Times have reported the fact that this therapy has never been utilized as much as it should by lymphoma patients for reasons that have nothing to do with its efficacy.
There are all sorts of issues ranging from inequitable Medicare reimbursement rates to unfounded fears by patients and even some doctors that this treatment is dangerous and problematic because of the radiation component.
There are numerous false notions about RIT, and unfortunately neither GSK nor the nation's oncologists have done enough to dispel them. For example, contrary to popular belief, there is no evidence that Bexxar increases the risk of secondary concerns any more than chemotherapy.
It's also not true, despite what some say, that there is too little data to make an informed decision about using RIT. An enormous amount of data has in fact been collected in the nearly two decades since trials for RIT began in 1990.
In short, Bexxar saved my life, and saved the lives of many others. It is nothing less than a tragedy that it is being shelved.