This is the first drug in 6 years to treat lung cancer but we seem to have a trend lately of the drugs being very expensive and not to mention the current shortage of generic drugs that treat cancer. A quick search of the internet says the cost will be $9600 a month so again that runs into some money pretty quickly. Now that we know the cost, please read the link below on how a new “scoring” algorithm has been developed to tell people how long they have to live…keep an eye out on this as we hope it will not be used to determine who gets care and who does not. Actually the link below discusses how formulas are being used both constructively and the potential for abuse so read up as everyone is combining data from all different types of sources today and we have ethics issues forming rapidly. BD
Prognostic Scoring Analysis System Can Tell Doctors How Long Cancer Patients Have to Live; Danger Zone As Far as Misuse With Drug and Treatment Access for Patients
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of XALKORI is based on objective response rates (ORR) and, as XALKORI received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
“The development of XALKORI – from publication of the discovery of the ALK fusion gene in NSCLC to FDA approval in just four years - is a remarkable feat in the oncology world and reinforces the importance of collaboration among academic research, pharmaceutical, diagnostic and regulatory organizations.”
“Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer. XALKORI is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease,” said Ian Read, president and chief executive officer of Pfizer. “The acceleration, collaboration and critical focus of the XALKORI clinical development program reflect Pfizer’s Precision Medicine approach to advancing our pipeline and strengthening our innovative core to deliver medicines that matter most.”
With the lastest press release from Pfizer about their new drug Xalkori, the queston of whether to consider spending $3,000 or more for a cell-based functional profiling test gets more interesting. The drug will cost $9,600 per patient per month and the gene test for it will cost $1,500 per patient. A biotech executive states the real cost of the drug is $9,600 plus 25 ALK tests, because that's how many patients will need to be screened for one to actually get Xalkori.ReplyDelete
There are lots of things which determine if drugs work, beyond the existence of a given target (like ALK). Does the drug even get into the cancer cell? Does it get pumped out of the cell? Does the cell have ways of escaping drug effects? Can cells repair damage caused by the drug? Do combinations of drugs work in ways which can't be predicted on the basis of static gene expression patterns?
Tumor biology is a lot more complex than we'd like it to be. Cancer is more complex than its gene signature. Many common forms of cancer present as a host of mutated cells, each with a host of mutations. And they're genetically unstable, constantly changing. That's why so many cancers relapse after initially successful treatment. You kill off the tumor cells that can be killed off, but that may just give the ones that are left a free reign.
The idea of searching for clinical responders by testing for a single gene mutation seems like a nice theoretical idea, but you may have to test for dozens of protein expressions that may be involved in determining sensitivity/resistance to a given drug. Because if you miss just one, that might be the one which continues cancer growth. And at $1,500 a pop, that's a lot of dough, on top of the inflated price of the single drug!
The key to understanding the genome is understanding how cells work. The ultimate driver is "functional" pre-testing (is the cell being killed regardless of the mechanism) as opposed to "target" pre-testing (does the cell express a particular target that the drug is supposed to be attacking). While a "target" test tells you whether or not to give "one" drug, a "functional" pre-test can find other compounds and combinations and can recommend them, all from the one test.