The FDA has approved Celgene’s supplemental New Drug Application (sNDA) of Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]) in combination with gemcitabine (Gemzar; Lilly) as first-line treatment for patients with metastatic adenocarcinoma of the pancreas.

Abraxane, in combination with gemcitabine, is the first treatment approved for metastatic adenocarcinoma of the pancreas in about eight years.

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The indication approval was based on results from MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, Phase 3, randomized, international study that evaluated a total of 861 chemotherapy-naïve patients with metastatic pancreatic cancer. The MPACT study was one of four studies to show an overall survival benefit over the past two decades.

Study results showed that 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. Also, 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.

Abraxane was granted a Priority Review designation by the FDA in May 2013.

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