(ChemotherapyAdvisor) – A newly-completed phase 3 clinical trial shows that Abraxane (paclitaxel injection) plus gemcitabine is associated with prolonged survival among patients with metastatic pancreatic cancer, according to an announcement by the Pancreatic Cancer Action Network and Celgene Corporation.
A multinational phase 3 study of 861 patients diagnosed with metastatic pancreatic cancer found “statistically significant improvement in overall survival” for patients receiving Abraxane injection plus gemcitabine, compared to patients receiving gemcitabine alone, according to the announcement.
“Historically, few effective treatment options for pancreatic cancer have existed,” said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. “We are thrilled to have a new treatment option for patients with advanced pancreatic cancer.”
No statistical details have yet been released. Results from the study will be presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January 2013, Celgene officials said.
“We look forward to learning more about the increase in survival when the full results from the study are released in January,” Fleshman stated, who added that clinical trials represent “the only way to make progress towards better treatments.”
Abraxane is paclitaxel modified by the addition of human albumin protein, according to the Celgene website. It was approved by the FDA in 2005 for breast cancer treatment. It was approved in October 2012 as a first-line treatment in combination with carboplatin for locally-advanced or metastatic non-small cell lung cancer (NSCLC) among patients who cannot undergo curative surgery or radiotherapy. Celgene also plans to seek FDA approval for Abraxane for the treatment of pancreatic cancer.