Positive CDF Decision for Abraxane, First New Treatment for Metastatic Pancreatic Cancer in 17 Years

As of today, Abraxane (paclitaxel formulated as albumin bound nanoparticles; nab-paclitaxel) in combination with gemcitabine, is available in England following its inclusion on the Cancer Drugs Fund (CDF) list.  

Dr Sebastian Cummins, Clinical Director of Oncology at Royal Surrey County Hospital, comments: "It is fantastic news that the application for nab-paclitaxel in combination with gemcitabine for the treatment of metastatic pancreatic cancer has been accepted by the CDF. This decision means that a new medicine is now available in a therapy area that has lacked substantial treatment advances for nearly two decades." 

Currently, pancreatic cancer is the fifth most common cancer killer in the UK, and more than 8500 people are diagnosed each year.[2,3] Survival rates are amongst the lowest of all the major cancers in the UK and only 15.7% of patients diagnosed in the advanced stage of the disease survive for one year after diagnosis.[4,5] Around 80% of patients are diagnosed once the cancer has already reached an advanced stage, when a cure is no longer an option.[6]

 
Results from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, which was published last year in the New England Journal of Medicine, showed that nab-paclitaxel, in combination with gemcitabine, demonstrated an increase in overall survival when compared to gemcitabine alone [(8.5 months vs. 6.7 months respectively) (HR 0.72; P=0.001)].]7]

The positive decision by the CDF was based on results presented recently during the American Society of Clinical Oncology Gastrointestinal Cancer (ASCO GI) Symposium in San Francisco. The results demonstrated an overall survival of 2.1 months when compared to gemcitabine alone [(8.7 months vs. 6.6 months respectively) (HR 0.72; P=0.0001)].[8]

 
Ms Alex Ford, Chief Executive of Pancreatic Cancer UK comments: “We are delighted by the CDF's decision to include Abraxane on its list of approved drugs. This will make a real and tangible difference to the lives of patients with metastatic pancreatic cancer as well as their families and loved ones.

"However, whilst extremely welcome, the CDF decision is only a stop-gap until NICE makes a more permanent appraisal decision in 2015. Moreover, the CDF only covers England, so patients in Scotland, Wales and Northern Ireland will have to wait for separate funding decisions being made in those countries  — time which many patients simply do not have.” 

Ali Stunt, Founder and CEO of Pancreatic Cancer Action comments: “We are absolutely delighted that Abraxane has been approved by the CDF as a treatment for metastatic pancreatic cancer. The committee have listened to us and come to the correct conclusion to make this novel therapy available to those eligible patients with metastatic pancreatic cancer.

"Historically, there has been very little hope for pancreatic cancer patients with most surviving for only 4–6 months from diagnosis. Additionally, significant underfunding for pancreatic cancer research has meant that there has been very little in the way of improvements in survival for these patients for decades.” 

“Therefore, it is only right that eligible patients should have immediate access to this medical advance.” 

Celgene will be submitting to the National Institute for Health and Care Excellence (NICE) in May 2014 but a decision will not be made until late 2014 or early 2015.  

Sam Pearce, Vice President and General Manager, Celgene UK & Ireland, said: “We are delighted that nab-paclitaxel has been approved for use on the CDF giving patients access to a new treatment option which has been shown to extend the lives of patients with metastatic pancreatic cancer.” 

References

[1] Celgene data on file. January 2014.

[2] www.bmj.com/content/344/bmj.e2476?variant=pdf Published May 2012. Accessed March 2014

[3] http://pancreaticcanceraction.org/pancreatic-cancer/about/prognosis-survival/ Accessed March 2014

[4] www.ons.gov.uk/ons/dcp171778_283644.pdf Published: 23 October 2012. Accessed December 2013

[5] http://pancreaticcanceraction.org/pancreatic-cancer/about/prognosis-survival/ Accessed February 2014

[6] www.pancreaticcancer.org.uk/media/100292/report_final_for_web.pdf Accessed March 2014

[7] www.nejm.org/doi/full/10.1056/NEJMoa1304369#t=abstract Accessed December 2013