FDA approves late-stage pancreatic cancer injectable

FDA expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane, Celgene) to treat patients with metastatic pancreatic cancer.

“The FDA approval of Abraxane offers another alternative form of treatment for pancreatic cancer, to reduce the growth of the certain tumors, which can offer hope for individuals who are diagnosed with this rare form of cancer,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “Since diagnosis can generally be made after there has been tumor growth, surgery may no longer be a viable option so the reduction or prevention of this growth can be a key measure to saving lives.”

Abraxane in combination with gemcitabine is the first new treatment approved for metastatic adenocarcinoma of the pancreas in nearly 8 years. The approval was based on results from MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase 3, randomized, international study.

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<.0001); a 28% overall reduction in risk of death. Abraxane plus gemcitabine demonstrated a median progression-free survival of 5.5 vs 3.7 months for gemcitabine alone (HR=0.69, P<.0001); a 31% reduction in the risk of progression or death. The overall response rate was 23% for the Abraxane plus gemcitabine arm versus 7% in the gemcitabine alone arm (P<.0001).

“Little progress has been made in the treatment of pancreatic cancer relative to other cancers over the last 4 decades, during which the 5-year survival rate for metastatic disease has remained relatively flat at just ~2%,” said Julissa Viana, director of public relations for Celgene. “Over the past 2 decades, more than 30 randomized phase 3 studies have been conducted in patients with advanced pancreatic cancer; the MPACT study was 1 of 4 studies to show an overall survival benefit.”

Neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration were the most common adverse reactions (≥20%) with a ≥5% higher incidence in the Abraxane /gemcitabine treatment group.

Pancreatic cancer is the fourth leading cause of cancer death in the United States. About 45,220 patients will be diagnosed and 38,460 will die from it in 2013, according to the National Cancer Institute. Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.