US FDA expands approval of Celgene’s Abraxane to pancreatic cancer

The US Food and Drug Administration (FDA) has approved Celgene's supplemental New Drug Application of Abraxane as a first-line treatment for patients with advanced pancreatic cancer. Abraxane was approved by the US FDA to treat breast cancer in 2005 and lung cancer in 2012.

Abraxane (paclitaxel protein-bound particles for injectable suspension) in combination with gemcitabine is the first new treatment approved for metastatic adenocarcinoma of the pancreas in nearly eight years. Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.

"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."

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. 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."

Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network.

The approval was based on results from a phase 3 clinical trial called MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), that were featured at this year's ASCO annual meeting and have been submitted for publication in a peer-reviewed journal.

The trial 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); 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; 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.

Over the past two decades, more than 30 phase 3 clinical trials have been conducted in patients with advanced pancreatic cancer and the MPACT study is only one of four studies to show an overall survival benefit.