Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency’s (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months.
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. Pancreatic cancer is currently the fourth most common cause of cancer death in the EU for men and women.1 Death rates from the disease are predicted to rise from 7.85 in 2009 to 8.01 in 2013 per 100,000 among men, and from 5.33 to 5.54 per 100,000 among women in same period.1 In fact, the pancreas is the only major cancer site for which no improvements in mortality rates is predicated for either sex.1 There have been no new treatments approved for pancreatic cancer in nearly seven years.
“The positive CHMP opinion on ABRAXANE with gemcitabine for metastatic pancreatic cancer is a significant step toward bringing the first new treatment option in many years to people diagnosed with this deadly disease, which has seen multiple clinical trial failures over the years,” said Alan Colowick, MD, President of Celgene Europe, the Middle East and Africa (EMEA). “Following a positive decision by the European Commission within the next few months, we hope to begin the important work of helping physicians and patients gain access to ABRAXANE plus gemcitabine, which has demonstrated statistically significant and clinically meaningful improvements in overall survival compared to gemcitabine alone, as reported recently in the New England Journal of Medicine.”
The CHMP positive opinion was based on the results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study published in the New England Journal of Medicine in its 16 October 2013 e-publication. 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, nab-paclitaxel 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<0.0001); a 28% overall reduction in risk of death.2
Grade 3 and higher adverse events that were reported more often with nab-paclitaxel plus gemcitabine versus gemcitabine alone were neutropenia, leukopenia, fatigue, and peripheral neuropathy.
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 Europe, 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 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 6 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, 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.