Australian biopharmaceutical company Specialized Therapeutics Australia (STA) announced that Abraxane (nanoparticle albumin-bound paclitaxel) in combination with gemcitabine is now approved by Australia’s Therapeutic Goods Administration (TGA) for the first-line treatment of metastatic pancreatic cancer.
The TGA approval for Abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
TGA approval was based on the pivotal, randomized, Phase 3 trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), published in the New England Journal of Medicine (NEJM) in October 2013. The study reported that patients treated with Abraxane plus gemcitabine had a statistically significant improvement in overall survival (OS) compared to patients receiving the current standard of care, gemcitabine monotherapy. An updated analysis of OS presented at a recent international cancer conference in January 2014 showed the survival benefit was further extended in the Abraxane plus gemcitabine arm, with a 2.1 month median OS improvement compared to gemcitabine alone.
MPACT is the first Phase 3 trial in metastatic pancreatic cancer to report greater than three-year survival rates, with 4% of patients in the Abraxane plus gemcitabine arm alive after three years, and 3% of patients alive at 42 months, compared to 0% in the gemcitabine alone arm at both time points.
STA Chief Executive Officer Carlo Montagner said TGA approval paves the way for Australian patients with metastatic pancreatic cancer to access this more effective treatment option.
“In Australia, pancreatic cancer is the fifth most common cause of death from cancer for both men and women, and very few treatment options exist for this group of patients. No new drugs have been approved by the TGA for this disease since 2006. We are extremely pleased to receive TGA approval in recognition that Abraxane is capable of prolonging survival for patients with metastatic pancreatic cancer, and look forward to a Pharmaceutical Benefits Scheme (PBS) listing for this difficult to treat cancer,” Montagner said.
Abraxane is now TGA approved for three indications; metastatic breast cancer, first-line Non-Small Cell Lung Cancer (NSCLC) and first-line metastatic pancreatic cancer.
STA is currently seeking a PBS listing for Abraxane in first line metastatic pancreatic cancer.
Date: March 18, 2014
Filed Under: Drug Discovery