Posts tagged ‘Crizotinib’
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.
Source: National Cancer Institute
Lung cancer and the molecular targets associated with it have been the theme for posts by Icarus Consultants’ “Dr Sally” on Pharma Strategy Blog this week.
Sally Church has a keen interest in lung cancer and serves on the board of Seattle based non-profit GRACE (Global Resource for Advancing Cancer Education).
Pharma new products professionals have a challenging role as they need to not only understand the science of new pathways and molecular targets, but how to apply this information in a dynamic, competitive landscape.
Bringing new products to market is not easy, and choosing the right molecular target is key to success. Clinical trials are costly not only for company resources, but use up valuable clinical trial subjects.
If you are not an avid reader of Pharma Strategy Blog, here’s a brief overview of the topics around lung cancer molecular targets that Sally wrote about this week:
Does chemotherapy improve PFS in non-squamous lung cancer?
Sally discusses new phase III data on whether it was safe and effective to continue pemetrexed as maintenance therapy for patients with advanced NSCLC. Her analysis of the data, is that “it looks to be a safe and viable option, albeit with a small additional increase of 1.3 months in survival.“
MET amplification and Resistance to EGFR therapy in lung cancer
Researchers have shown that MET amplification leads to resistance with EGFR inhibitors such as gefitinib (Iressa), raising the possibility that combining a MET inhibitor with erlotinib might be a good combination.
Sally discusses what the future holds for two of the leading compounds in phase II/III ARQ-197 and METMab. If you are interested in the answer to the question “What does the data with MET inhibitors mean?, check out Pharma Strategy Blog.
Update on new targets in squamous cell carcinoma of the lung
Acccording to Sally, “there are no approved targeted therapies specially for squamous cell carcinoma.” However, there is a potential new molecular target on the horizon: DDR2 (discodin domain receptor 2). “What does this new research on DDR2 tell us?” The answer is in Sally’s insightful post.
Update on EGFR inhibitors, KRAS and T790M mutations in lung cancer
This post has a really useful table of current EGFR inhibitors that are approved and in development. Some of the inhibitors in phase III trials include necitimumab and nimotuzumab. Try saying those words after a couple of beers. According to Sally, many people call them “Nessie” and “Nimo”. Sally brings to life some of the other new products in development including, PF299804. She discusses in detail the challenges that have to be overcome in targeting T790M mutations.
Update on emerging therapies in ALK+ lung cancer
Within adenocarcinomas, EFGR isn’t the only potential target mutation. Recent research with crizotinib has highlighted the role ELM4-ALK translocations have to play. As Sally notes, the development of crizotinib by Pfizer is “an exciting development.” There are, however, other ALK inhibitors in development including IPI-504, LDK378, ASP3026 and AP26113. “This is a small, but rapidly growing niche.”
FGFR1 mutations in squamous cell lung cancer
Sally discusses recent research using Pfizers pan-FGR inhibitor PD173074. You can read more about this on Pharma Strategy Blog.
The landscape in lung cancer is rapidly changing as new molecular targets are identified and new-targeted therapies are developed.
If you would like to know more about this market, the molecular targets and where your new product may have the most opportunity, please contact us.
Sally Church, PhD our oncology new products expert, is passionate about making a difference to the lives of patients with cancer. She channels her many talents and energies into helping pharma and biotech companies assess the best targets for their new products. It’s a job that requires science, marketing strategy and commercial awareness; a unique blend of skills.
Sally’s recent post on Pharma Strategy Blog entitled “Accelerated approval and cancer drugs” considers how best to bring new cancer drugs to market? Should promising oncology new products go from phase 2 clinical trials to market without the need for a large and expensive phase 3 registration study? If so, what happens when the data doesn’t pan out as happened with Roche/Genentech’s bevacizumab (Avastin) in breast cancer?
You can read more about Sally’s thoughts on Pharma Strategy Blog.
Sally Church on Pharma Strategy Blog reviews a 2011 paper on molecular subsets in lung cancer published by Lowly & Carbonne in Nature Reviews Clinical Oncology.
The molecular subsets to-date include KRAS, EGFR and ALK, but what is interesting is that half remain unknown.
You can read Sally’s blog post for her thoughts on what the next target may be after ALK and crizotinib.
Crizotinib and ALK rearrangements in lung cancer: an interview with Dr Ross Camidge
November 30th, 2010
Daedalus
Published by Sally Church on Pharma Strategy Blog