Celgene's chemotherapy drug Abraxane has been approved in the US for the treatment of advanced pancreatic cancer, the fourth leading cause of cancer death in the country.
Following a priority review, the US Food and Drug Administration concluded that Abraxane (nab-paclitaxel) is safe and effective for first-line use in patients with late-stage adenocarcinoma of the pancreas, offering the first new option to extend survival in nearly eight years.
According to the regulator, surgery is the only way of permanently removing or curing pancreatic cancer, but it is usually too late by the time the cancer is diagnosed.
“In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life," said Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The drug's approval came on the back of data from a Phase III trial (MPACT) showing a statistically significant improvement in overall survival in patients taking a combination of Abraxane and current standard of care gemcitabine (Eli Lilly's Gemzar) compared to those taking the latter alone (8.5 versus 6.7 months).
Cuts disease progression
The combination also demonstrated a 59% increase in one-year survival (35% vs 22%) and doubled the rate of survival at two years (9% vs 4%), as well as statistically significant improvements in key secondary endpoints, including a 31% reduction in the risk of progression or death.
On the downside, the list of commonly observed side effects included a decrease in infection-fighting white blood cells (neutropenia), a low level of platelets in the blood (thrombocytopenia), fatigue, nerve damage in the arms and legs (peripheral neuropathy), nausea, hair loss (alopecia), tissue swelling, diarrhoea, fever, vomiting, rash and dehydration.
The approval mark's Abraxane's third in cancer arena: the drug was approved by FDA for the first-line treatment of non-small cell lung cancer in combination with carboplatin in October, following a green light in breast cancer since 2005, and pulls in sales of around $439 million a year.
Celgene acquired the drug through its $2.9-billion purchase of Abraxis back in 2010.