Late last friday afternoon, Pfizer received FDA approval for Xalkori® (crizotinib) in non-small cell lung cancer (NSCLC). The companion diagnostic test from Abbott was approved at the same time. Sally Church on Pharma Strategy Blog has written about the Xalkori approval and the “wonderful news” this represents for those affected by this disease.
Sally notes that the Xalkori® story “represents another major advance for targeted therapy in a clearly defined subset of patients.” The cost of treatment is $9,600 per month. In addition there will be the cost of screening the majority of NSCLC patients who do not have an abnormal anaplastic lymphoma kinase (ALK) gene. “ALK aberrations typically occur in the order of 4-7% of NSCLC patients.”
Sally in her informative Pharma Strategy Blog post also shares the story from Dr Jack West in Seattle of one patient who has been on the drug for 2 years and is now coaching soccer!
Post Glivec/Gleevec, which Sally helped bring to market while at Novartis Oncology, it’s good to see two new highly targeted therapies that will have a major impact on the lives of patients.
Not withstanding the excellent results, it remains to be seen whether the high price of recently approved oncology drugs such as Zelboraf, Adcetris and Xalkori represents a sustainable business model in the long-run. Drug companies argue that how society spends its healthcare dollars is a matter of public policy and choice by the taxpayers, rather than an issue of how they choose to price their products.
As Pieter Droppert noted on Biotech Strategy Blog last week while writing about the Google/Department of Justice Settlement, many prescription drugs are cheaper in Canada than in the United States. Is it inevitable that the continued rise in the price of oncology drugs in the United States will eventually force some form of price regulation or costing model based on performance metrics such as Quality-Adjusted Life Years (QALY)?
In the meantime, the Xalkori approval is one that Pfizer can be proud of. Despite all that’s been said about the lack of innovation in the pharmaceutical industry, it’s an example of how knowledge of the underlying biology and mechanism of action of a disease can be leveraged in drug development. The result is a new product brought to market within a relatively short period of time.
In addition to Sally Church’s recent post on Pharma Strategy Blog about the crizotinib FDA approval, she previously posted an excellent interview with Dr Ross Camidge on “crizotinb and ALK rearrangements in lung cancer.“ This is well worth reading if you missed it the first time.