US-based Celgene Corporation’s chemotherapy drug Abraxane has received approval by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer, in combination with gemcitabine.
The FDA concluded that Abraxane (nab-paclitaxel) was a safe and effective drug for patients with late-stage adenocarcinoma of the pancreas, providing the first new option to increase survival rates in almost eight years.
At the moment, the only way to permanently remove or cure pancreatic cancer is through surgery, but it is usually too late by the time the cancer is detected.
FDA’s Center for Drug Evaluation and Research Office of Haematology and Oncology Products director Richard Pazdur said: "In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life."
Data from a Phase III trial (MPACT) that showed a significant improvement in extending the survival of patients who took a combination of Abraxane and gemcitabine, which is Eli Lilly’s Gemzar, compared with those that took Gemzar alone.
This combination also showed a 59% increase in the one-year survival rate and doubled that rate at two years, while demonstrating a 31% decrease in the risk of progression or death.
The drug’s side effects include a decrease in white blood cells (neutropenia), a reduced amount of platelets in the blood (thrombocytopenia), exhaustion, nerve damage in both the arms and legs (peripheral neuropathy), nausea, hair loss (alopecia), tissue swelling, diarrhoea, fever, vomiting and rash, as well as dehydration.
Celgene acquired the drug through its $2.9bn purchase of Abraxis in 2010; the drug brings in sales of around $439m a year as it is used to treat non-small cell lung cancer and breast cancer.
Photo: Abraxane has been approved by the FDA for the treatment of pancreatic cancer. Image: courtesy of Wikipedia.
