Sep 25 2014
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, today announced that Swissmedic, the regulatory authority for Switzerland, has granted approval for ABRAXANE® (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer.
ABRAXANE has been approved in more than 30 countries for metastatic pancreatic cancer and over 40 countries for metastatic breast cancer.
The approval for ABRAXANE in pancreatic cancer is particularly meaningful, as there have been no new medications approved in nearly 7 years and more than 30 clinical trials have failed to lead to regulatory approval in the EU for advanced or metastatic pancreatic cancer. In Switzerland, pancreatic cancer has the fourth highest cancer mortality rate, affecting an estimated 1000 patients in the next year.2 Median life expectancy after diagnosis with metastatic pancreatic cancer is only 3–6 months.3,4
Metastatic breast cancer (MBC) is a late-stage or advanced form of breast cancer that occurs when cancer spreads from the breast to other areas of the body. MBC is the top cause of cancer-related deaths among women in Switzerland, accounting for 19 % of all cancer-related deaths. An estimated 5400 women will be diagnosed with breast cancer, and 1340 will die from the disease in 2014, according to Krebsliga Schweiz / Ligue Suisse contre le Cancer.2
“This approval is a significant milestone for patients and their families across Switzerland, as we now have a new treatment option that can meet an unmet need, particularly in the treatment of pancreatic cancer,” said Professor Eric Raymond, Head of the Oncology Department at the CHUV, Lausanne. “My perception is that this approval is going to mandate a change in the way that we treat patients, offering a new option with a good efficacy and safety profile.”
Tuomo Pätsi, newly appointed President of Celgene Europe, the Middle East and Africa (EMEA), added: “Since announcing the European Commission approval for the European Union earlier this year for the pancreatic cancer indication, we have been able to make this innovative medicine available, giving an overall survival benefit in a disease that historically has resulted in death too soon after diagnosis. Today’s announcement is a significant step forward and we remain committed to developing innovative treatments to improve the lives of those with this devastating disease.”
The Swissmedic decision for the pancreatic cancer indication was based on the results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomised, international study published in the New England Journal of Medicine in its 31 October 2013 edition. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries, including North America, Eastern and Western Europe, and Australia. In the study, ABRAXANE plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.001); a 28% overall reduction in risk of death.5
The Swissmedic approval for the breast cancer indication was based mainly on data from the pivotal phase III randomised CA-012 trial including 454 patients.6 The primary endpoint, response rate (complete and partial response according to the RECIST criteria) showed a statistically significant result for Abraxane vs. conventional (non-albumin-bound) paclitaxel (24.0% vs. 11.1%; p <0.001). Median time to disease progression was 5.0 vs. 2.7 months.
About ABRAXANE®
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.
In the European countries covered by the European Commission, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
In the United States, ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE has been globally approved in more than forty countries for the treatment of metastatic breast cancer (MBC).
In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Japan, and New Zealand.
In September 2013, the FDA approved ABRAXANE as first–line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. ABRAXANE is also approved for the treatment of metastatic pancreatic cancer in Argentina, Australia, and Canada, Ecuador, Lebanon, and New Zealand.
Source: http://www.celgene.com/