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.
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.
F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer (New York Times)
FDA okays Celgene's Abraxane for pancreatic cancer (Reuters)