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ABRAXANE® Product Photo

Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

ABRAXANE® Product Photo

ABRAXANE® Product Photo

“For more than 15 years, treatment with gemcitabine has been the standard of care in this disease. The addition of ABRAXANE to gemcitabine demonstrated meaningful improvements across key efficacy outcomes, including overall survival, with a well-characterized safety profile,” said Jean-Pierre Bizzari, M.D., Executive Vice President of Hematology and Oncology for Celgene Corporation.

“We are pleased that patients with advanced pancreatic cancer now have a new treatment option helping to expand the treatment landscape for the fourth leading cause of cancer death in the United States,” said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. “The FDA approval of ABRAXANE is an important step for a disease that desperately needs treatment advances to improve patient outcomes. The Pancreatic Cancer Action Network will continue to work with the medical community to build upon this success and advance our goals in the fight against pancreatic cancer.”

ABRAXANE in combination with gemcitabine is the first new treatment approved for metastatic adenocarcinoma of the pancreas in nearly eight years. The approval was based on results from MPACT ( Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study, that were featured at this year’s ASCO annual meeting and have been submitted for publication in a peer-reviewed journal. Over the past two decades, more than 30 randomized, phase III studies have been conducted in patients with advanced pancreatic cancer and the MPACT study was one of four studies to show an overall survival benefit. In the MPACT study, which involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer, 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<0.0001); a 28% overall reduction in risk of death. ABRAXANE plus gemcitabine demonstrated a median progression-free survival (PFS) of 5.5 vs. 3.7 months for gemcitabine alone (HR 0.69, P<0.0001); a 31% reduction in the risk of progression or death. The Overall Response Rate (ORR) was 23% for the ABRAXANE plus gemcitabine arm versus 7% in the gemcitabine alone arm (p<0.0001).

“Historically, patients with pancreatic cancer have not experienced benefit with many of the drugs so useful in other malignancies. This is beginning to change,” said Margaret A. Tempero, M.D., Director and Professor of Medicine, UCSF Pancreas Center. “The combination of ABRAXANE and gemcitabine represents an important new therapeutic option for patients with pancreatic cancer. It also provides a foundation for future clinical research.”

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