STA gets TGA nod for Abraxane in pancreatic cancer
Specialised Therapeutics Australia (STA) has secured TGA approval for its licensed cancer drug Abraxane as a combination treatment for metastatic pancreatic cancer.
The regulator has approved Abraxane in combination with gemcitabine for the first-line treatment of metastatic adenocarcinoma of the pancreas.
The decision was based on results of a phase III trial of the drug - the first phase III study in metastatic pancreatic cancer to report greater than three-year survival rates. Around 4% of patients receiving both Abraxane and gemcitabine were alive after three years, compared to 0% in a gemcitabine alone arm.
Abraxane was developed by Abraxis BioScience, which was acquired by Celgene in 2010. STA has distribution rights to the treatment in Australia and New Zealand.
STA CEO Carlo Montagner said this marks the first time the TGA has approved a new drug for pancreatic cancer 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,” he said.
The TGA has also approved Abraxane in metastatic breast cancer and in first-line non-small cell lung cancer (NSCLC).
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