Feb 12 2015
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, today announced that ABRAXANE®(paclitaxel formulated as albumin-bound nanoparticles; nab-paclitaxel), in combination with gemcitabine, has now received a positive recommendation for the treatment of metastatic pancreatic cancer by the Scottish Medicines Consortium (SMC) within the National Health Service Scotland.
The decision follows the recent NHS England announcement to defer their review of ABRAXANE® for metastatic pancreatic cancer, allowing the treatment to remain on the National Cancer Drugs Fund (NCDF) list until a final decision is made.
The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women across the European Union. Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately two to six months. In the UK, pancreatic cancer is the fifth most common cancer killer with approximately 8,800 new cases diagnosed each year. In Scotland an estimated 770 new patients are diagnosed and over 740 die from the disease each year.
Professor Jeff Evans, Professor of Translational Research at the University of Glasgow said: “I welcome the Scottish Medicines Consortium decision to approve the prescribing of ABRAXANE® in Scotland. Pancreatic cancer has extremely low survival rates as the majority of patients are diagnosed at an advanced stage. ABRAXANE® has shown that it is able to increase survival for patients with metastatic pancreatic cancer and now sufferers of the disease in Scotland will be able to use this treatment.”
The SMC decision is based on results from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, published in the October 2013 edition of the New England Journal of Medicine, which demonstrated an increase in median overall survival of 1.8 months when compared to gemcitabine alone [(8.5 months vs. 6.7 months respectively) (HR 0.72; P<0.001)]. Updated results published in the February 2015 edition of the Journal of the National Cancer Institute demonstrated an increase in the median overall survival benefit of 2.1 months when compared to gemcitabine alone [(8.7 months vs. 6.6 months respectively) (HR 0.72; P<0.0001)]. 9 Grade 3 and higher adverse events that were reported more often with ABRAXANE® plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy.
Ms Alex Ford, Chief Executive of Pancreatic Cancer UK, said: “We are absolutely delighted with the SMC’s decision. They have listened to the positive input received from patients and clinicians and they should be applauded for doing so.
The decision means that eligible patients in Scotland will be now be able to access this treatment for free on the NHS, alongside patients in England and Wales, which is fantastic news. It is particularly important as, currently, pancreatic cancer causes almost 5% of cancer deaths in Scotland and it is important that as many patients as possible are given every opportunity to access life-extending treatment. And whilst not every patient will be fit enough to be able to use ABRAXANE®, a significant number will and we hope this will give them the opportunity of spending more time with their loved ones.”
Ali Stunt, Founder and CEO of Pancreatic Cancer Action said: “This is fantastic news for metastatic pancreatic cancer patients in Scotland who have been waiting for this treatment for almost 12 months. The unmet need in pancreatic cancer is significant due to the terrible prognosis associated with the disease and the lack of new treatments that are coming through. At Pancreatic Cancer Action, we welcome the SMC’s decision to make ABRAXANE® available to all eligible patients in Scotland.”
Wim Souverijns, Vice President and General Manager, Celgene UK & Ireland, said: “Celgene is dedicated to working with all the reimbursement bodies in the UK and Ireland and across the world to make sure that as many eligible patients can be treated with ABRAXANE® as possible. Access to innovative cancer medicines generates clear benefits to patients. Therefore, widening access to life-extending treatments for cancer patients has the potential to reduce the rise in cancer mortality rates that has been seen over the last two decades and help to increase survival rates in pancreatic cancer which have hardly moved in decades.
The SMC have recognised the clinical benefit of ABRAXANE®, so Scottish patients will now be able to receive the treatment alongside their counterparts in England and Wales and in many countries across the European Union where the medicine is approved and available to patients.”
Source: http://www.celgene.com/