Health Canada Approves ABRAXANE Plus Gemcitabine for First-Line Treatment

Health Canada Approves ABRAXANE® Plus Gemcitabine for First-Line Treatment
of Patients with Metastatic Pancreatic Cancer
High unmet need addressed with first new approved treatment in eighteen years
MISSISSAUGA, ON – (August 6, 2014) – Health Canada has approved PrABRAXANE®
for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle,
albumin-bound [nab®] paclitaxel) for first-line treatment of adult patients with metastatic
pancreatic cancer. The approval is welcome news for Canadians who are diagnosed with
metastatic pancreatic cancer, and represents the first approved treatment for this disease
in nearly two decades.
The Health Canada approval was based on the results of MPACT (Metastatic Pancreatic
Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study
which was published in the New England Journal of Medicine in October 2013. The
MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic
cancer from 11 countries, including Canada, and showed a statistically significant
improvement in median overall survival with ABRAXANE plus gemcitabine compared to
gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.0001); a 28% overall reduction in
risk of death.1
“This is a cancer where there are few effective treatments and the first-line approval of
ABRAXANE in combination with gemcitabine represents an important advance,” said. Dr.
Malcolm J. Moore, Program Head, Medical Oncology and Hematology and Director,
McCain Centre for Pancreatic Cancer at the Princess Margaret Cancer Centre, University
Health Network in Toronto and an investigator in the MPACT trial. “This approval will
certainly have an impact on the way physicians manage this disease in the
future. Pancreatic cancer is a tough one to deal with; patients are desperate and
physicians are on the lookout for new advances. The addition of ABRAXANE to
gemcitabine has demonstrated significant benefits in overall survival and this gives our
patients hope.”
“It`s been quite some time since we’ve seen any type of treatment advance for pancreatic
cancer making this news so important for patients. This will give patients the hope that
is needed to continue to fight,” said Laurie Ellies, Co-founder, and Acting Executive
Director of Pancreatic Cancer Canada. “Over the past decade, there has been a
significant improvement in cancer survival rates. Sadly, the same cannot be said about
pancreatic cancer. We’re dealing with a deadly disease. For a person diagnosed with
metastatic disease it can be a question of weeks. This year alone, we can expect an
estimated 4,700 Canadians will be diagnosed with this disease. If anything, this number
tells us that we are desperately in need of more research and treatments - patients are
counting on it.”
ABRAXANE is commercially available in Canada.
About Pancreatic Cancer
Pancreatic cancer is the fourth-leading cause of cancer-related death in Canada.2 The
pancreas is composed of two main cell types: exocrine and endocrine. Adenocarcinoma
is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas.3
For all stages of pancreatic cancer combined, the five-year survival rate in Canada is
about 8%. For metastatic pancreatic cancer, the five-year survival is approximately 2% in
ABRAXANE® is an albumin-bound form of paclitaxel that is manufactured using patented
nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free
of solvents. The most common adverse reactions (≥ 20%) with a ≥ 5% higher incidence
in the ABRAXANE/gemcitabine treatment group are neutropenia, fatigue, peripheral
neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased
appetite, rash, and dehydration.4
Please refer to the ABRAXANE product monograph for complete safety information.
ABRAXANE in combination with gemcitabine for the treatment of metastatic pancreatic
cancer is approved in the United States and 30 other countries, including Argentina and
Australia as well as countries in Europe.
About Celgene
Celgene Corporation is an integrated global biopharmaceutical company engaged
primarily in the discovery, development and commercialization of novel therapies for the
treatment of cancer and inflammatory diseases through gene and protein regulation. For
more information, please visit the company's website at
All trademarks used or mentioned in this release are protected by law.
Stephanie Convery, Weber Shandwick, (416) 642-7945,
[email protected]
Von Hoff DD, Ervin T, Arena FP, et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus
Gemcitabine. New England Journal of Medicine. 2013; 369(18):1691-703.
2 Canadian Cancer Society, Statistics Canada, Public Health Agency of Canada. Canadian Cancer
Statistics 2014. Special topic: Skin cancers. Available at:
anadian-Cancer-Statistics-2014-EN.pdf Accessed August 5, 2014.
3 Canadian Cancer Society. Malignant tumours of the pancreas. Available at: Accessed August 5, 2014.
4 ABRAXANE® Product Monograph. July 15, 2014. Celgene Corporation.